Satyanarayana Raju V
Chennai
Summary
Accomplished pharmaceutical professional with over 12+ years of experience seeking a challenging role to drive operational excellence and organizational growth. Demonstrated expertise in pharmaceutical production, quality systems, process enhancement, and team management. Skilled in implementing quality and safety standards, optimizing operations, and solving complex problems through analytical thinking, effective communication, and a flexible, detail‑focused approach.
Overview
14
14
years of professional experience
Work History
Senior Technical lead
HCL technologies
Chennai
04.2024 - Current
- Project: Johnson and Johnson Pharma chemicals and biologics should costing
- Client: Johnson and Johnson pharmaceuticals
- Manage and mentor the Pharma cost management team through routine review of technical results, coaching, training, and helping to create reusable templates for customer presentation.
- Contribute to project timelines and cost structures.
- Be the main point of contact for the program with the customer, drive and manage the relationship with the customer to expand current service and identify new opportunities in the organization.
- Performing 'Should Costing' of procured chemicals and/or biologics for the customer by mapping the end-to-end manufacturing process, equipment used, labor, capital investment and other operational costs.
- Expertise in engineering judgement for key assumptions like step yield, % loss, mass and material balances, energy balances, and % recovery for the various process steps.
- Ensure the team members are making reasonable engineering assumptions to arrive at the should-cost.
- Drive Pharma MFG engineering business by identifying other potential services (eg Process transfer, tech transfer, MFG technical writing, etc) that can be offered by the team based on their skill level and experience.
Senior Technical lead
HCL technologies
Chennai
03.2025 - 11.2025
- Project: Supplier Change controls
- Client: Johnson and Johnson pharmaceuticals
- Led and actively contributed to supplier change control projects, managing change notifications from initiation through final closure.
- Administered 800+ supplier change controls as Team Lead, ensuring timely progression, compliance, and quality alignment across all phases.
- Independently created and processed 300+ supplier change controls as a team member using TrackWise and Comet systems.
- Served as the primary point of contact for clients, internal stakeholders, and suppliers, building strong working relationships and ensuring clear communication.
- Owned end-to-end change management, from receipt of supplier change notification through assessment, planning, implementation, release, and closure.
- Drove change control execution across all phases, including impact assessment (quality, regulatory, technical), change planning, implementation tracking, and effectiveness verification.
- Coordinated cross-functional reviews with Quality, Regulatory, Engineering, Procurement, and Manufacturing teams to ensure compliant and timely approvals.
- Ensured adherence to GMP, GDP, and client-specific quality requirements throughout the change management lifecycle.
- Monitored change control metrics, risks, and timelines to support on-time closure and continuous improvement initiatives.
- Mentored team members on change control workflows, system usage, and quality expectations to improve overall team efficiency and consistency.
Assistant Manager
Eugia Pharma specialties UNIT-III (Aurobindo Group)
Hyderabad
05.2018 - 04.2024
- Planning and supervising of daily production manufacturing and fill finish activities.
- Intimate understanding of chemical manufacturing processes and synthesis of Drug.
- Assist in improving standards of manufacturing by explaining drug chemistry and necessity of producing quality product of API manufacturing for patients' safety.
- Worked closely with plant leads and R&D experts in process optimization and development.
- Indenting receiving cross verifying of raw materials with batch records.
- Evaluate alignment with internal standards and relevant regulatory requirements.
- Planning of process activity and maintaining manpower as per the requirement.
- Accurately evaluate equipment readiness, facility infrastructure, and documentation controls.
- Ensure compliance during manufacturing and throughout production process of APIs.
- Preparation of BMR and BPR as per the MFC and regulatory requirements.
- Preparation and execution of validation protocols.
- Engage with cross-functional teams to support product development.
- Review and approval of process related SOPs with pictorial representation.
- Working exposure in TRIMS (training information management).
- Working exposure in QMS (quality management system) for change controls CAPA's and deviations review and approval.
- Working exposure in DMS (Document Management system) for preparation of SOPs.
- Preparation of FMEA's (Failure mode Effective analysis) risk assessment and investigation reports regarding Drug manufacturing process.
- Work experience in operation and execution of validation process of equipment's manufacturing vessels, reactors, washing and Depyrogenation tunnels and homogenizers and area.
- Active participation and successful completion of customer audits and USFDA audits.
- Handling the Pilot Plant projects for scale up, exhibit, PV, commercial batches.
- Attending for trainings like on job, cGMP, external and giving trainings on process related SOPs as per the schedule/training matrix.
- CGMP Documentation practices, control and initiation of quality notifications.
- Responsible for review and online completion of documentation like log sheets and BMRs and BPRs.
- Responsible for DQ, IQ, OQ and PQ of equipment's and autoclaves and filling machines.
- Tracking and Intimation to engineering department regarding calibration and PMPs of equipment.
- Daily, monthly and Quarterly calibration of equipment's.
Production Jr. Executive
Pfizer pharmaceutical India Pvt. Ltd.
Vizag
08.2014 - 12.2017
- Handling all component and solution manufacturing activities in sterile injectable formulation.
- Participated and worked in 600L and 6000L Propofol commercial line qualifications and commercial batch manufacturing around 200 batches.
- Good work experience in DCS (distributed control system) SAP, AMPS, LIMS and electronic BMR and logbooks.
- Handling the Pilot Plant projects for scale up, exhibit, PV, commercial batches.
- Handling all GDP documentation through SAP transaction.
- Ensuring cleaning and sanitization, rotation of disinfectants in clean rooms as per the procedures.
- Taking approvals/line clearance from QA department before starting of each activity.
- Handling of HOMOGENIZER (Gaulin).
- CGMP Documentation practices, initiation of quality notifications.
- Responsible for documentation like log sheets and updating and closing of BMRs.
- Compliance to all approved procedure, documents and GMP activities during production.
Executive
Biological E Ltd.
Hyderabad
04.2012 - 08.2014
- Involved in purification and conjugation Process of HIB vaccine and Detoxification and purification of Diphtheria vaccine.
- Handling of autoclaves (Machin Fabrik, FEDEGARI), DHS, centrifuges (BECKMAN COULTER).
- Protein Concentration, Diafiltration and Purification (TFF and Depth filters), conjugation and alkaline degradation.
- Sterile bulk filtration through 0.22µ filters in grade B area.
- Preparation of Lot Summary Protocols and Deviation reports.
- Audits face: USFDA, WHO, CDSCO, EU-GMP, ANVISA.
Assistant Manager
Cipla Pvt. Ltd
Goa
05.2018
- Managed major commercial project in establishing most commercial oncology molecules doxorubicin liposomal injection and paclitaxel Nano particle injection in scale up and exhibit batch completion.
- Good exposure in handling scale-up and exhibit batch manufacturing.
- Good Hand on experience in handling lipex machine and homogenizers and tangential flow filtration equipment's.
Education
Post Graduation - Biotechnology
Madras University
ChennaiGraduation - Chemistry
Andhra University
VisakhapatnamSkills
- Good pharmaceutical knowledge
- Inventory management
- Knowledge on QMS tools
- Good exposure on GMP and GDP
- Compounding and manufacturing
- Process optimization and development
- Equipment's and area qualification
- Manpower management and cost analyses
Disclaimer
I hereby declare that the information furnished above is true to the best of my knowledge.
Languages
English
First Language
Telugu
Proficient
C2
Hindi
Upper Intermediate
B2
Timeline
Senior Technical lead
HCL technologies
03.2025 - 11.2025
Senior Technical lead
HCL technologies
04.2024 - Current
Assistant Manager
Eugia Pharma specialties UNIT-III (Aurobindo Group)
05.2018 - 04.2024
Assistant Manager
Cipla Pvt. Ltd
05.2018
Production Jr. Executive
Pfizer pharmaceutical India Pvt. Ltd.
08.2014 - 12.2017
Executive
Biological E Ltd.
04.2012 - 08.2014
Post Graduation - Biotechnology
Madras University
Graduation - Chemistry
Andhra University