Senior Manager QA - Amol Pharmaceutical Pvt Ltd - Jaipur
(2023-04)
Amol Pharmaceutical Pvt. Ltd (APPL) is a sister concern of US Pharma Lab (USA) and Amol Biotech Ltd (China). Certified for USFDA, ANVISA, MD-SAP, FSSAI, WHO-GMP, USDA- Organic, NSF-GMP, Ayurvedic –GMP, ISO 13485:2016, ISO 9001:2015, ISO 14001:2018, ISO 45001:2018, Koshar, Halal, UL certification, CDSCO, SEDEX 4 pillar.
- Ensure compliance with WHO-GMP, US FDA, ANVISA, ICH guidelines, and local regulatory requirements
- Implementation of ISO 9001, ISO14001, ISO 22000, ISO45001 and FSSC 22000 requirement
- Review and approve SOPs, policies, and quality procedures
- Drive continuous improvement initiatives
- Regulatory Compliance & lead preparation for USFDA, KFDA, ANVISA, MDSAP and NSF-GMP audits
- Ensure closure of audit observations, CAPAs, and compliance of gaps
- Coordinate responses to warning letters, deviations, and non-conformances
- Review Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs)
- Approve or reject finished products based on quality data
- Ensure data integrity and documentation compliance
- Lead investigations related to Deviations, OOS (Out of Specification), OOT (Out of Trend), and Market complaints
- Approve CAPA plans and verify effectiveness
- Conduct root cause analysis using tools like Fishbone, 5-Why, etc.
- Process validation, Cleaning validation, Equipment qualification, Computer system validation
- Ensure validation protocols and reports meet regulatory expectations
- Approve vendors and contract manufacturers
- Conduct supplier qualification and audits
- Ensure raw materials and packaging materials comply with specifications
- Ensure ALCOA+ principles for data integrity
- Control document issuance, archival, and revision systems
- Monitor electronic quality systems and audit trails
- Lead QA managers, executives, and auditors
- Train teams on GMP and compliance requirements
- Evaluate risks affecting product quality and patient safety
- Track KPIs such as Deviations, CAPA closure, Audit findings, Market complaints, Batch rejection trends
- Present quality metrics to senior management
- Building a quality culture across the organization
- Supporting regulatory filings and market expansions
- Present management review meetings to Top management
- Budgeting and resource planning for QA functions
- Supporting digital quality transformation initiatives
- Product design & development close coordination with R&D team
- Review and approval of Tech transfer /Product suitability reports
- Review, Investigation, and approval of OOS/OOT/Specification/ STP/Protocol/Reports/Stability study report
- Pest control management
- Review and approval of artwork
- Taking Care for Export Business Specific For UK, CANADA, and ISRAEL
- Vendor qualification for procurement of Raw and Packaging Materials
- Third party Contract Manufacturing Organizations (CMO) Qualification
- Third party Contract Manufacturing Organizations (CMO) assessment periodically and quality rating
- Review and approval of system related SOPs like Change control, Training Management, Recall Management, CAPA, Audit management etc
- Quality management system (QMS) compliance and continual improvement
- Internal Auditing and make sure for CAPA implementation
- CAPA sustainability monitoring
- External audit and CAPA review
- Technology transfer and review of documents
- Training management and evaluations
- Quality compliance at CMOs during batch manufacturing and packaging
Manager CQA - Dabur Research Foundation - Sahibabad
(2022-09 - 2023-04)
- Taking Care for Export Business Specific For UK, CANADA, and ISRAEL
- Fluent In Communications
- Vendor qualification for procurement of Raw and Packaging Materials
- Third party Contract Manufacturing Organizations (CMO) Qualification
- Third party Contract Manufacturing Organizations (CMO) assessment periodically and quality rating
- Review and approval of system related SOPs like Change control, Training Management, Recall Management, CAPA, Audit management etc
- Quality management system (QMS) compliance and continual improvement
- Internal Auditing and make sure for CAPA implementation
- CAPA sustainability monitoring
- External audit and CAPA review
- Technology transfer and review of documents
- Training management and evaluations
- Quality compliance at CMOs during batch manufacturing and packaging
Manager (promoted from Dy. Manager) - Tirupati Lifesciences Pvt Ltd - Paonta Sahib (H.P)
(2013-03 - 2022-08)
Tirupati life sciences is Tirupati group of company which producing products in different dosage forms like Tablet, Capsule, Syrup and Powder. Tirupati life sciences working for different Indians and overseas companies like Dr. Reddy's Laboratories Ltd, Sun Pharmaceutical Ltd., Cipla Ltd., Abbott Nutrition, Glanbia Performance Nutrition India Pvt Ltd, Herbalife international pvt. Ltd., 4 life, Shakle, Alembic Pharmaceutical ltd., Sanofi Inida Ltd., Etc. Tirupati group having approx. 1000 Cr.
Annual
Turnover. Tirupati lifesciences Facility Registered & Certified for 21 CFR Part 111, SEDEX 4 pillar Audit, Best place to work certified.
- Handling of Customer Complaints & First point of contact person for consumer response programme
- Review, implementation and compliance for Legal L&W, LM, FSSAI, ISO 14001 requirements
- Review, implementation and compliance of SOPs
- Review and implementation of Food Safety and Quality Management System
- Handling of QMS (Change Control, Risk assessment, Impact assessment, Deviation, Internal audit, Incident management, RCA, CAPA etc.)
- Internal and external Audit and Compliances
- Vendor Qualifications & development
- Preparation, review and implementation of Quality policy and objectives
- Product traceability (forward and backward) and recall
- Review and approval of Stability Reports
- Review and updating of Site Master File
- Review of Annual Product Quality Review
- Investigation and review of Out of Specifications and Out of trend (OOT)
- Review and approval of Specification and STPs
- Review of qualification and validation protocol and reports
- To ensure issuance, revision, and retrieval of all controlled documents
- Process validation and Hold time validation
- To impart individual or group training to all employees on SOP on SOP, Handling of market complaints, change control, Good Manufacturing practice, Internal Auditing & Visual quality inspection criteria
- Approval of Batch Manufacturing and packaging Records
- Competency Mapping and Training Management
- To conduct sudden/unplanned random checks in warehouse, manufacturing, packaging, engineering operations and submit report to top management for information along with correction & corrective action of the observations
- Review of Standard Operating Procedures and Standard Sanitation Procedures
- Conducting of process validation
- Internal auditing and preparation of non compliance report
- Review of Batch Manufacturing and Packing Records
- Verification of implementation of proposed Corrective and preventive action (CAPA)
- Responsible for investigation deviations
- Issuance, revision and retrieval of all controlled documents
- To ensure for preparation & review of SOPs
- Responsible for In-process quality control activities
- To ensure for timely issuance, retrieval, trainings & implementation of SOPs
- Responsible for Review of Batch Manufacturing & Packing Records
- Responsible for Qualification of all new and existing equipments
- Responsible for Re-qualification of equipments as per approved plan
- Responsible for timely preparation of Annual Product Quality Review
- Responsible for conducting of process validation along with team
- Responsible for preparation and updating of site master file
- Responsible for preparation of Validation Master Plan
Assistant Manager - Sarvotham Care - Baddi
(2012-05 - 2013-02)
- Review of Standard Operating Procedures and Standard Sanitation Procedures
- Conducting of process validation
- Internal auditing and preparation of non compliance report
- Review of Batch Manufacturing and Packing Records
- Verification of implementation of proposed Corrective and preventive action (CAPA)
- Responsible for investigation deviations
- Issuance, revision and retrieval of all controlled documents
Officer - Surya Pharmaceutical Ltd - Panchkula
(2011-03 - 2012-05)
- To Ensure for review of Quality Data
- To Ensure for review of Batch Processing Records
- Responsible for preparation of Equipment Qualification Protocol
- Responsible for preparation & review of Standard Operating Procedure
- Responsible for investigation of Deviations & submit report to HOD
- Responsible for preparation of Annual Product Quality Review
- Responsible for review of Standard Operating Procedure
- To Ensure for timely issuance, and retrieval of Standard Operating Procedures
- To Ensure for timely issuance of Batch Processing Records
- Responsible for inspection of the finish products before dispatch
- Responsible for Handling of Export and Domestic Dispatch of the Finish Product
- Line clearance of various in-process activities like dispensing, sifting, blending, Granulation, Coating etc
- In-process testing like Moisture analysis, Disintegration, Friability, Hardness testing, along with required documentation
- Calibration of weighing balances and documentation
- Handling of control samples and appropriate documentation
- Sudden inspection of Raw material and Packaging materials
Tr. Chemist to Sr. Chemist - Nectar Life Sciences Ltd - DeraBassi, Mohali (PB)
(2009-12 - 2011-02)
- To Ensure for review of Quality Data
- To Ensure for review of Batch Processing Records
- Responsible for preparation of Equipment Qualification Protocol
- Responsible for preparation & review of Standard Operating Procedure
- Responsible for investigation of Deviations & submit report to HOD
- Responsible for preparation of Annual Product Quality Review
- Responsible for review of Standard Operating Procedure
- To Ensure for timely issuance, and retrieval of Standard Operating Procedures
- To Ensure for timely issuance of Batch Processing Records
- Responsible for inspection of the finish products before dispatch
- Responsible for Handling of Export and Domestic Dispatch of the Finish Product
Chemist - Orision Pharma International - Kalaamb (H.P)
(2008-08 - 2009-12)
- Line clearance of various in-process activities like dispensing, sifting, blending, Granulation, Coating etc
- In-process testing like Moisture analysis, Disintegration, Friability, Hardness testing, along with required documentation
- Calibration of weighing balances and documentation
- Handling of control samples and appropriate documentation
- Sudden inspection of Raw material and Packaging materials
