DIVAKARLA SURYANARAYANA
HEAD OPERATIONS & SITE HEAD
Bengaluru,KA
Summary
Site Head-Operations BIF Plant leading greenfield sterile manufacturing across cartridges, PFS, and vial filling lines. Drives end-to-end commissioning, qualification, validation, technology transfer, and audit readiness for high-containment aseptic operations using isolator technology and EU Annex 1 standards. Improves throughput, asset utilization, and compliance through capacity planning, OEE improvement, and manufacturing digitalization.
Overview
2
2
Languages
29
29
years of professional experience
Work History
Site Head-Operations BIF Plant
Biocon Limited,Bengaluru
11.2025 - Current
- Overview:
- Leading the establishment and commercialization of greenfield sterile manufacturing facilities for cartridges, PFS, and vial manufacturing. Responsible for end-to-end greenfield project execution covering facility design, equipment selection, technology transfer, commissioning, qualification, validation, regulatory readiness, and commercial operations. In addition, driving Operational Excellence initiatives including CIP (Continuous Improvement Programs), cost reduction, Overall Equipment Effectiveness (OEE) improvement, product-to-equipment mapping, manufacturing capacity enhancement, campaign batch planning, and digitalization to maximize productivity, asset utilization, and business performance
- Lead operations across sterile manufacturing platforms including cartridges, PFS, and vial filling lines, while establishing and managing high-containment facilities using isolator technology for aseptic processing.
- Provide Quality oversight for technology transfer of sterile injectable products from internal development organizations into commercial manufacturing.
- Collaborate with Development, MSAT, Analytical dept, and Regulatory Affairs during process development, validation, and lifecycle management.
- Review and approve Technology Transfer Protocols, Risk Assessments, Control Strategies, Validation Master Plans, and PPQ strategies.
- Support CMC documentation for regulatory submissions and post-approval manufacturing changes.
- Ensure Quality governance for engineering batches, exhibit batches, PPQ batches, and commercial launches.
- Drive cross-functional Quality Risk Management using ICH Q9 principles during scale-up and process optimization.
- Manage end-to-end technology transfers in compliance with EU Annex 1 and global regulatory standards, including execution of line modifications using single-use systems (SUS) and ready-to-fill assemblies for biological products.
- Ensure continuous audit readiness for global regulatory inspections (USFDA, EMA, MHRA) and collaborate closely with Quality, Engineering, and Regulatory teams to support validation and commercialization activities.
- Established and operationalized cartridge, PFS, and vial manufacturing capabilities in high-containment environments, delivering multiple sterile manufacturing line projects aligned with regulatory and operational requirements.
- Led end-to-end design and deployment of isolator systems for high-potency products including GLP-1, defining URS for closed processing, glove integrity, RTPs, alpha-beta systems, and VHP bio-decontamination cycles.
- Integrated isolators with automated filling lines, lyophilizers, and packaging and inspection systems to enhance operational efficiency and ensure regulatory compliance.
- Improved capacity utilization through product-to-line mapping and planning, and managed technology transfers and scale-up activities with a focus on regulatory alignment.
- Executed end-to-end workforce planning for a greenfield project, overseeing recruitment, manpower budgeting, onboarding, training, and workforce optimization.
- Led digitalization in the greenfield facility through MES.
Senior GM Operations and Plant Head
Eugia Steriles Pvt Ltd. (Aurobindo JV), Visakhapatnam
03.2022 - 10.2025
- Overview:
- Led the complete greenfield establishment of sterile injectable manufacturing facility, overseeing a CAPEX investment of approximately US$69 million (₹600 crore) from concept through design, commissioning, qualification, validation, technology transfer, commercialization, and routine operations. Managed 7 sterile manufacturing lines (Aseptic Vial, TS, Cartridge, and PFS) with a workforce of over 500 employees. Successfully led the site through two USFDA, one ANVISA, Health Canada, and TGA inspections while implementing end-to-end digitalization across manufacturing and operational processes to drive compliance, efficiency, and operational excellence.
- Key Responsibilities:
- Led operations for 8 manufacturing lines in Visakhapatnam, ensuring efficient production operations for regulated markets.
- Overseen the execution of plant setup, expansion, and the installation & commissioning of equipment, ensuring projects are completed on time and within budget.
- Maintained audit-ready status for site, facilitating successful inspections and regulatory compliance.
- Developed and implemented operational policies to enhance quality and reduce costs, contributing to overall operational efficiency.
- Managed capital and revenue budget, aligning financial planning with strategic goals to support growth and sustainability.
- Led project activities from conceptualization to final execution, including finalizing technical specifications and ensuring successful project delivery.
- Key Achievements:
- Successfully completed 4 manufacturing lines (1 Aseptic Vial, 1 Ampoule, 2 TS Vial Lines) within 2 years, initiating production and commercialization.
- Effectively recruited and onboarded 400+ members, playing a pivotal role in establishing the foundation of the company from the ground up.
- Led the site through a successful regulatory audits (EU & 2 FDA) with zero major findings, demonstrating a commitment to quality and compliance that positively impacted the company's reputation and market standing.
- Transitioned from manual logbooks to electronic logs using software, and currently overseeing the digitalization process of electronic batch records (e-BR).
- Worked on the 3 additional manufacturing lines' exhibit batches: 1 Aseptic Vial, 1 Cartridge, 1 BFS line and 1 PFS line.
Plant Head
Optimus Pharma, Hyderabad
02.2021 - 02.2022
- Overview:
- Oversaw all operations related to the production of dosage forms (tablets, capsules, and ointments), ensuring efficiency, quality, and compliance with regulatory standards. Managed production schedules, optimized manufacturing processes, and coordinated with other departments to meet production targets.
- Key Responsibilities:
- Developed and implemented strategic plans that optimized production efficiency and aligned with company goals.
- Managed production schedules, resources, and budgets to meet production targets and timelines.
- Managed production schedules, resources, and budgets, ensuring timely achievement of production targets.
- Identified and implemented process improvements to enhance productivity and reduce costs.
- Liaised with senior management, delivering updates on plant performance and driving alignment on strategic initiatives.
- Drove a culture of safety, quality, and continuous improvement throughout the plant.
Head of Quality
Neo Pharma, Abu Dhabi
08.2019 - 09.2020
- Overview:
- Led a team of quality assurance professionals to ensure the highest quality and compliance standards in the plant. Oversaw the implementation and maintenance of robust quality management systems in line with regulatory requirements, including developing and enforcing quality policies, conducting audits, and managing the release of products to the market.
- Oversaw all aspects of Quality Assurance, including Product Assurance, Batch Release, Technology Transfers, Validations, Complaints, Product Quality Reviews, Stability Studies, and Transportation Studies.
- Managed quality metrics, compliance, and quality management systems, while overseeing regulatory and customer audits.
- Led vendor management efforts, including qualification, audits, compliance, and quality agreements, to maintain supplier quality and address out-of-specification incidents through effective corrective and preventive actions (CAPA).
- Conducted management review meetings, driving timely execution and closure of action items to reinforce accountability and continuous improvement in quality processes.
- Revolutionized the Quality Management System by spearheading the digitalization initiative, resulting in a 30% reduction in paperwork and administrative burden while enhancing data accuracy and accessibility.
- Implemented innovative quality control measures, resulting in a 20% decrease in product defects, leading to significant cost savings and increased customer satisfaction.
- Introduced proactive quality risk management strategies, reducing non-conformances by 25% and mitigating potential risks to product quality and patient safety.
Dy. General Manager - Quality
Apotex Research Pvt. Ltd., Bengaluru
06.2016 - 08.2019
- Overview:
- My primary focus was on leading and overseeing the validation and compliance activities at 2 sites. This encompassed ensuring compliance with regulatory requirements, developing and implementing validation strategies, and managing a team of validation professionals. I played a key role in ensuring the integrity and reliability of processes, systems, and equipment within the pharmaceutical manufacturing environment. I participated in various audits conducted by regulatory bodies such as HC, EU, MHRA, and FDA.
- Developed process validation strategies for alternative vendor development of drug substances and packaging materials, ensuring compliance through risk assessment methodologies.
- Developed and implemented validation protocols for OSD (Oral Solid Dosage) manufacturing processes.
- Conducted risk assessments to identify critical process parameters and develop validation approaches.
- Performed equipment qualification and process validation activities in compliance with regulatory requirements.
- Collaborated with cross-functional teams to ensure alignment with project timelines and objectives.
- Provided technical guidance and support to ensure successful execution of validation activities.
- Participated in regulatory inspections and audits, addressing validation-related inquiries and findings.
- Key Achievements:
- Executed cleaning validation strategy for multi-product facility per latest EU guidelines, applying Quality Risk Management (QRM) principles and conducting Industrial Hygiene (IH) studies for MHRA compliance.
- Implemented a streamlined validation process that reduced validation cycle times by 20%, resulting in significant time and cost savings for the OSD plant.
- Played a key role in achieving regulatory compliance in validation activities, leading to successful audits by regulatory agencies such as the FDA and MHRA.
- Mentored and trained junior validation professionals, enhancing team competency and reducing reliance on external consultants.
DGM-CQA
Aurobindo, Hyderabad
09.2015 - 06.2016
- Overview:
- Led corporate validation function, ensuring quality and compliance across all formulation sites of Aurobindo Pharma Limited (APL).
- Self-motivated, with a strong sense of personal responsibility.
- Worked effectively in fast-paced environments.
- Skilled at working independently and collaboratively in a team environment.
Associate Director-Technical Services
Dr. Reddy's Ltd, Hyderabad
03.2009 - 09.2015
- Overview:
- Led the end-to-end execution of three greenfield pharmaceutical manufacturing projects, including an oncology sterile injectable (vial) facility, an oncology oral solid dosage (tablet) facility, and a general oral solid dosage (OSD) manufacturing facility. As Head of Manufacturing Science & Technology (MSAT) for Dr. Reddy's formulation business, provided technical leadership for greenfield projects across multiple sites, driving the complete project lifecycle from concept, facility design, engineering, equipment selection, cleanroom qualification, FAT, SAT, commissioning, qualification, validation, technology transfer from R&D, regulatory approvals, and commercialization. Partnered with Manufacturing and Engineering teams to improve Overall Equipment Effectiveness (OEE), optimize process performance, and enhance operational reliability across formulation facilities. Also led qualification remediation initiatives at Dr. Reddy's US manufacturing site, resolving critical compliance gaps and strengthening inspection readiness for global regulatory agencies
- Led tech services function, ensuring validation and qualification compliance across all formulation sites of Dr. Reddy's with a team of 37.
- Designed facility layout and equipment specifications, including User Requirement Specifications (URS), while conducting Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) to guarantee robust equipment performance.
- Developed and performed IH studies for Anti hormonal and cytotoxic block for OEL determination as part of cross contamination studies.
- Oversaw cleaning, equipment qualification, and CSV automation to maintain compliance and operational standards.
- Leading the design of facility layout and equipment specifications, including User Requirement Specifications (URS) and conducting Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) to ensure robust equipment performance.
- Accountable for Cleaning, Equipment qualification and CSV automation.
- Responsible for overseeing the seamless transfer of products from Research and Development (R&D), encompassing both Injectable and OSD (Oral Solid Dosage) formulations, to various manufacturing sites.
- Conducting media fill runs based on comprehensive risk assessments.
- Prepare technical justifications and compliance documentation for any observations identified.
- Key Achievements:
- Developed external manufacturing facilities to meet the standards of regulatory as well as Dr. Reddy's quality standards.
Assistant Manager QA
Sandoz Pvt. Limited, Mumbai
03.2007 - 02.2009
- Overview:
- Played a key role in the establishment of Sandoz's greenfield sterile injectable manufacturing facility in Mumbai for Carbapenem dry powder injections using advanced isolator technology, designed to supply regulated US and European Union (EU) markets. Reported directly to Global Quality, Kundl, Austria, and led quality, qualification, and validation activities supporting technology transfer from the Austria manufacturing site to Mumbai. Drove facility qualification, aseptic process validation, cleaning validation, process validation, and commercialization while ensuring compliance with global quality standards and regulatory requirements.
- Key Responsibilities:
- Coordinated validation activities for Carbapenem injection product transfers between India and Kundl (Austria).
- Developed and reviewed SOPs for QA and validation systems to ensure compliance with quality standards.
- Created cleaning validation policies and process validation plans to support timely product commercialization.
- Managed the preparation, planning, and monitoring of Aseptic Media Fill Validations (AMFV) and associated policies.
Assistant Manager R&D QA
AET Laboratories Limited, Hyderabad
06.2005 - 02.2007
- Overview:
- Played a key role in establishing a greenfield pilot manufacturing facility at AET Laboratories, the Indian R&D and pharmaceutical development center of a Germany-based organization. Led facility qualification, commissioning support, Validation Master Planning, Quality Management System (QMS) implementation, and regulatory compliance activities while reporting to the European Global Quality organization. Collaborated with global cross-functional teams to harmonize quality systems and validation standards and participated in supplier qualification and GMP audit programs across Europe, South Korea, Taiwan, and China. Certified Lead Auditor with extensive experience in global vendor qualification, quality system assessments, and regulatory compliance supporting international pharmaceutical operations.
- Key Responsibilities:
- Managed facility qualifications for greenfield pilot project and implemented quality management system.
- Developed Master Validation Plan, Site Master Plan, and master cleaning validation plan to ensure compliance.
- Served as lead auditor for API vendors, assessing compliance and quality standards.
Sr. Executive QA
Intas Pharma Pvt. Ltd, Ahmedabad
03.2005 - 06.2005
- Conducted internal audits and managed document control to ensure compliance and quality in in-process activities.
- Led cross-functional teams to streamline operational workflows and enhance productivity.
- Developed and implemented strategic initiatives to optimize supply chain processes.
- Oversaw compliance with industry regulations, ensuring adherence to quality standards.
Executive Validations QA
Lupin Ltd, Bhopal
05.2002 - 02.2005
- Managed revalidation activities and led qualification of Goa OSD facility to ensure compliance with regulatory standards.
- Handled cGMP and validations for injectable cephalosporins, ensuring adherence to quality standards.
- Developed protocols for cross-contamination and transport validations to mitigate risks in production processes.
- Led USFDA and customer audits, including BAXTER US.
Chemist QA
Gland Pharma Ltd, Hyderabad
09.1998 - 04.2000
- Supervised IPQA and qualified equipment for USFDA-approved injectable and ophthalmic facility, ensuring compliance with regulatory standards.
- Developed SOPs and document control processes, facilitating successful customer audits.
- Developed and validated analytical methods for quality control of pharmaceutical products.
- Conducted complex chemical analyses using HPLC and GC techniques to ensure product compliance.
- Led cross-functional teams in troubleshooting and optimizing laboratory processes for efficiency.
Chemist QA
Hi-Tech Pharma Ltd, Hyderabad
01.1998 - 05.1998
- Coordinated production planning and cGMP implementation for diverse formulations to ensure compliance in a GMP plant.
- Conducted qualitative and quantitative analysis to ensure product quality and compliance with regulatory standards.
- Developed and optimized chemical formulations to enhance product efficacy and performance.
- Implemented laboratory best practices, resulting in improved safety protocols and reduced errors.
Education
M. Pharmacy -
VL College of Pharmacy
Raichur, India 04.2001 -
Bachelor of Pharmacy -
VL College of Pharmacy
Raichur, India06-1997
Skills
Green field facility design and qualification
Quality operations
Process design & validation
Aseptic processing & terminal sterilization
Technology transfer
Commercialization planning
Operational excellence
CAPEX planning
Regulatory inspection readiness
Financial planning & budget management
Timeline
Site Head-Operations BIF Plant
Biocon Limited,Bengaluru
11.2025 - Current
Senior GM Operations and Plant Head
Eugia Steriles Pvt Ltd. (Aurobindo JV), Visakhapatnam
03.2022 - 10.2025
Plant Head
Optimus Pharma, Hyderabad
02.2021 - 02.2022
Head of Quality
Neo Pharma, Abu Dhabi
08.2019 - 09.2020
Dy. General Manager - Quality
Apotex Research Pvt. Ltd., Bengaluru
06.2016 - 08.2019
DGM-CQA
Aurobindo, Hyderabad
09.2015 - 06.2016
Associate Director-Technical Services
Dr. Reddy's Ltd, Hyderabad
03.2009 - 09.2015
Assistant Manager QA
Sandoz Pvt. Limited, Mumbai
03.2007 - 02.2009
Assistant Manager R&D QA
AET Laboratories Limited, Hyderabad
06.2005 - 02.2007
Sr. Executive QA
Intas Pharma Pvt. Ltd, Ahmedabad
03.2005 - 06.2005
Executive Validations QA
Lupin Ltd, Bhopal
05.2002 - 02.2005
M. Pharmacy -
VL College of Pharmacy
04.2001 -
Chemist QA
Gland Pharma Ltd, Hyderabad
09.1998 - 04.2000
Chemist QA
Hi-Tech Pharma Ltd, Hyderabad
01.1998 - 05.1998
Bachelor of Pharmacy -
VL College of Pharmacy