AMBADAS ZADE
D1/501, Brahmand D Block, Thane
Summary
Quality management leader with extensive experience in operational excellence within the pharmaceutical sector. Demonstrated success in overseeing quality operations across various contract manufacturers, enhancing compliance and promoting cross-functional collaboration. Focused on continuous improvement and cultivating a culture of quality and data integrity.
Overview
18
18
years of professional experience
Work History
Senior Manager, Quality External Mfg.
BAYER PHARMACEUTICALS PVT. LTD
Thane
04.2021 - Current
- Managed end-to-end quality operations across 11 CMOs in India and Bangladesh.
- Ensured readiness of third-party manufacturers through performance monitoring and compliance oversight.
- Accounted for quality assurance and capability on all formulations produced at CMOs.
- Led cross-functional teams to implement strategic initiatives, achieving alignment and collaboration across departments.
- Championed process improvement initiatives, enhancing operational efficiency and ensuring robust quality control.
- Participated in CMO lifecycle processes, including selection, qualification, and phase-out.
- Steered supplier evaluation management processes to uphold quality standards for managed suppliers.
- Monitored supplier performance through regular dialogues and evaluations, identifying risks and driving corrective actions.
- Conducted quality audits according to schedule, ensuring timely CAPA implementation.
- Facilitated training sessions to enhance team capabilities and knowledge sharing.
- Developed and monitored project plans to ensure alignment with corporate goals.
- Supported strategy deployment as QEM representative in relevant decision-making boards.
Commercial Country Quality
BAYER PHARMACEUTICALS PVT. LTD
Thane
05.2020 - 04.2021
- Managed quality oversight of import products, resolving supply chain deviations and temperature excursions to maintain product integrity.
- Ensured quality oversight and compliance across distribution functions in all warehouses in India.
- Led country quality initiatives to maintain high standards and compliance across quality functions in India.
- Performed GMP/GDP audits for assigned sites according to audit calendar.
- Administered quality management systems including change control, deviations, market complaints, and CAPA.
- Handled document management for SOPs, annual product quality reviews, investigations, stability reports, and process validations.
- Reviewed and executed technical agreements to ensure compliance with industry standards.
- Oversaw warehouse operations to enhance efficiency and streamline processes.
Manager, Quality Technical Operations
PROCTER & GAMBLE HEALTH LTD. (FORMELY MERCK LTD.)
Mumbai
06.2016 - 04.2020
- Managed quality operations for a portfolio across 12 manufacturing sites.
- Oversaw quality technical operations in contract manufacturing environments.
- Preparation of audit calendar for CMO, CTL, RM / PM and Finished Product Suppliers.
- Planning & Performing the Qualification / Routine / For cause Quality Audits in accordance with the company norms & regulatory guidance.
- Escalated critical audit findings to Global Quality team and conducted risk assessment of site.
- Review of audit compliance report and follow up for CAPA plan to ensure timely closure of audit observation.
- Verified effectiveness of corrective and preventive actions implemented at CMOs, CTL, and Finished Product Suppliers.
- To prepare and review GMP/Technical Agreements for CMOs & Finished Product Suppliers.
- Ensuring smooth product launch and technology transfer at CMOs.
- Prepared process validation protocols and reports.
- To review the site documents / compliances to the GMP during the technology transfer activities at CMOs.
- To review of Technology transfer protocol and reports, Master Formula and Master Packing record, Finished Product and Stability specifications.
- Tracking of Stability samples for Accelerated and Real time testing conditions.
- Preparation of product quality review reports as per the PQR calendar.
- To follow up for the annual product review report from all CMOs.
- To prepare & review of data on monthly basis for CPV. Verification of process robustness through Continuous Process Verification (CPV).
- Followed up on actions for recommendations and product process improvements based on product quality review findings.
- Review of the data with respect to schedule reporting period of all products manufactured at CMOs.
- To perform Quality Risk Assessment, to identify the risks and prepare mitigation plans, in line with standards.
- Managed change control, complaints, and deviation management.
Sr. Executive R&D, Quality Assurance
USV LTD.
Mumbai
06.2015 - 06.2016
- Established Pilot Lab for manufacturing Bio-batches, facilitating DCGI submission.
- Reviewed and validated batch manufacturing records for Bio-batches, ensuring regulatory compliance.
- Review of stability data of Bio-batches.
- Conducted periodic reviews of quality system documents, maintaining adherence to industry standards.
Sr. Executive, Process Validation, Quality Assurance
DR REDDYS LABS
Hyderabad
10.2012 - 06.2015
- Improved process compliance by managing 15 validation batches, ensuring quality control and regulatory adherence.
- Conducted incident investigations, authored investigation write-ups, and performed root cause analysis to address quality issues.
- Reviewed and implemented change controls for new products, revalidations, and equipment changes, ensuring thorough impact assessments.
- Prepared annual product quality review and continuous process verification report to ensure compliance and support decision-making.
Executive, In-Process, Quality Assurance
LUPIN LTD
Mandideep
09.2009 - 10.2012
- Conducted in-process quality assurance activities on shop floor to ensure compliance with standards.
- Reviewed equipment qualification protocols and reports for IQ, OQ, and PQ to validate operational readiness.
- Performed scheduled self-audits and prepared comprehensive audit reports to identify compliance gaps.
- Review of investigations related to deviations, OOS, OOT's, Complaints etc.
Executive, Quality Assurance
PARENTRAL BIOTECH LTD.
Indore
12.2008 - 09.2009
- Biological Development Division, Quality Assurance
- Implemented quality management system to streamline processes and improve overall product quality.
- Drafted, executed, and implemented standard operating procedures to ensure compliance and enhance operational consistency.
- Prepared batch manufacturing records to support quality assurance and regulatory compliance.
Officer, Quality Assurance
UNIMAX LABORATORIES
Faridabad
01.2008 - 11.2008
- Conducted in-process checks as Quality Assurance chemist in manufacturing of solid dosage forms, ensuring compliance with regulatory requirements.
- Executed implementation of documentation for quality assurance, production, and quality control processes.
- Managed daily operations for laboratory testing and quality assurance.
- Developed and implemented standard operating procedures for laboratory processes.
- Coordinated training sessions for new staff on safety protocols and equipment use.
Education
Bachelor in Pharmacy -
Amravati University
Amravati07-2007
Diploma In Pharmacy -
Mumbai technical board
Maregoan07-2004
Higher Secondary School Certificate -
Janta Mahavidylaya College
Chandrapur01-2002
Secondary School Certificate - Matriculation
Kirti Convent School
Chandrapur01-2000
Skills
- Regulatory compliance
- Quality risk management and governance
- Data integrity and inspection readiness
- Validation processes
- Technology transfer and product introduction
- Supplier & CMO Quality Management
- Laboratory compliance
- Cross-functional collaboration
- Quality leadership and strategy
Accomplishments
• Gold Medalist, gold medallist in Diploma of Pharmacy, 1st year, 2003-2004.
• Achievers Award, awarded in Merck Ltd. for handling the most technology transfers of products (22) in a calendar year at the Achievers Award held in 2018 in Malaysia.
• Top Performance Award, awarded with 2 consecutive Top Performance Awards in Bayer for contribution to the investigation of stability failure in 2023 and new product launches in 2024.
• Outstanding Performer, awarded with Outstanding Performer in 2018 at Merck and in 2022 at Bayer.
• Workshop Participant, actively participated in the 2nd workshop on Marketing Authorization and licensing of vaccines organized by CDSCO - WHO, 9-14 March '09.
• Regulatory Audit, actively participated in regulatory audits like USFDA, TGA, PMDA, WHO, MHRA, MCC, ANVISA, and other customer audits.
• Achievers Award, awarded in Merck Ltd. for handling the most technology transfers of products (22) in a calendar year at the Achievers Award held in 2018 in Malaysia.
• Top Performance Award, awarded with 2 consecutive Top Performance Awards in Bayer for contribution to the investigation of stability failure in 2023 and new product launches in 2024.
• Outstanding Performer, awarded with Outstanding Performer in 2018 at Merck and in 2022 at Bayer.
• Workshop Participant, actively participated in the 2nd workshop on Marketing Authorization and licensing of vaccines organized by CDSCO - WHO, 9-14 March '09.
• Regulatory Audit, actively participated in regulatory audits like USFDA, TGA, PMDA, WHO, MHRA, MCC, ANVISA, and other customer audits.
Languages
- English, Native
- Hindi, Native
- Marathi, Native
Timeline
Senior Manager, Quality External Mfg.
BAYER PHARMACEUTICALS PVT. LTD
04.2021 - Current
Commercial Country Quality
BAYER PHARMACEUTICALS PVT. LTD
05.2020 - 04.2021
Manager, Quality Technical Operations
PROCTER & GAMBLE HEALTH LTD. (FORMELY MERCK LTD.)
06.2016 - 04.2020
Sr. Executive R&D, Quality Assurance
USV LTD.
06.2015 - 06.2016
Sr. Executive, Process Validation, Quality Assurance
DR REDDYS LABS
10.2012 - 06.2015
Executive, In-Process, Quality Assurance
LUPIN LTD
09.2009 - 10.2012
Executive, Quality Assurance
PARENTRAL BIOTECH LTD.
12.2008 - 09.2009
Officer, Quality Assurance
UNIMAX LABORATORIES
01.2008 - 11.2008
Bachelor in Pharmacy -
Amravati University
Diploma In Pharmacy -
Mumbai technical board
Higher Secondary School Certificate -
Janta Mahavidylaya College
Secondary School Certificate - Matriculation
Kirti Convent School