Vallabh Parmar

About the Company

Vins Bioproducts Limited is a leading biopharmaceutical company based in Hyderabad, Telangana, India, established in 1997 and actively manufacturing life‑saving biological products and antisera for emergency medical conditions.

The company specializes in the production of equine‑derived immunoglobulins and antitoxins, including anti‑snake venom serum, anti‑rabies immunoglobulin, tetanus and diphtheria antitoxins, scorpion venom antiserum, and gas gangrene antitoxin. These products are manufactured in compliance with stringent WHO cGMP and international quality standards at state‑of‑the‑art facilities that include advanced laboratories and a large equine farm dedicated to plasma collection and processing.

Key Responsibilities-QA Head (Vaccine & Sera Products)

• Lead the overall Quality Assurance function across all manufacturing units, ensuring compliance with cGMP, WHO, and regulatory standards for biologics, antisera, and vaccines.
• Established and maintained a comprehensive Quality Management System (QMS) to ensure compliance with regulatory standards.
• Managed final product release processes for antisera vaccines and other biological products to ensure compliance with quality standards.
• Manage and supervise validation and qualification activities, including equipment & utilities qualification, process validation, cleaning validation, and aseptic process simulation (media fill studies).
• Ensure documentation accuracy, data integrity, and regulatory compliance for all QA operations.
• Lead regulatory inspections, customer audits, and internal audits, ensuring timely closure of observations and implementation of corrective actions.
• Implement Deviation Management, CAPA, Change Control, and Risk Assessment systems to continuously improve quality standards.
• Monitor environmental and utilities control programs, contamination prevention strategies, and compliance of cleanroom operations.
• Drive cross-functional collaboration with Production, QC, R&D, and Engineering teams to resolve quality issues and ensure product quality.
• Mentor, train, and develop the QA team, promoting a culture of accountability, continuous improvement, and compliance excellence.
• Approve and oversee raw materials, in-process materials, and finished product quality in line with regulatory and internal quality standards.
• Support tech transfer, new product introduction, and scale-up activities ensuring adherence to quality and regulatory guidelines.

About the Company

Atlantic Lifesciences Limited is a leading sterile pharmaceutical manufacturing company based in Larkpleku, Greater Accra Region, Ghana. Established in 2017, it specializes in the production of a wide range of sterile dosage forms, including Large Volume Parenteral (intravenous infusions), Small Volume Parenteral, eye/ear/nasal drops, anesthetic solutions, biological products, vaccines, and sera — all manufactured in compliance with WHO cGMP standards and regularly inspected by the Ghana Food and Drugs Authority.

Key Responsibilities – QA Head (Vaccine & Sera Products)

• Lead the overall Quality Assurance function for vaccine and sera manufacturing, ensuring compliance with cGMP, WHO, USFDA, EMA, and other regulatory standards.
• Develop, implement, and maintain Quality Management System (QMS), SOPs, and policies aligned with regulatory and organizational requirements.
• Oversee in-process quality monitoring (IPQA), batch record review, and release of vaccine and sera batches.
• Supervise validation and qualification activities, including process validation, cleaning validation, equipment and utilities qualification, and aseptic process simulation (media fill studies).
• Ensure robust documentation practices, data integrity, and regulatory compliance across all QA operations.
• Lead regulatory inspection preparedness, including supporting audits from regulatory authorities, customers, and third-party auditors.
• Implement and monitor Deviation Management, CAPA, Change Control, and Risk Assessment systems for continuous quality improvement.
• Manage environmental monitoring programs, utilities monitoring, and contamination control strategies to maintain sterile production standards.
• Drive cross-functional collaboration with production, engineering, R&D, and QC teams to resolve quality issues and enhance product quality.
• Mentor and develop the QA team, ensuring a culture of quality, accountability, and continuous improvement.
• Evaluate and approve raw materials, packaging materials, and finished product quality standards in line with company policies and regulatory expectations.
• Oversee tech transfer, scale-up, and introduction of new vaccine or sera products in compliance with quality and regulatory guidelines.

About the Company

Zydus Lifesciences Limited is a globally recognized pharmaceutical company focused on the development, manufacturing, and marketing of innovative healthcare solutions, including pharmaceuticals, vaccines, biologics, and specialty products. The company operates world-class manufacturing facilities compliant with USFDA, EMA, and other international regulatory standards, supplying medicines to more than 50 countries worldwide.

Key Responsibilities-Manager (Leading Validation in Vaccines Products)

• Preparation, review, and execution of Validation Master Plan (VMP) in compliance with cGMP and regulatory guidelines.
• Perform qualification of equipment and utilities, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Execution and documentation of process validation to ensure consistent manufacturing processes and product quality.
• Perform cleaning validation for manufacturing equipment to confirm removal of product residues and cross-contamination control.
• Conduct aseptic process simulation (media fill studies) to verify sterility assurance in aseptic manufacturing processes.
• Responsible for qualification of critical utilities such as HVAC, purified water systems, compressed air, nitrogen, and clean steam systems.
• Perform Computer System Validation (CSV) activities including preparation of validation protocols and reports.
• Preparation, review, and approval of validation protocols, reports, and supporting documentation.
• Monitor revalidation activities and ensure periodic review of validation status.
• Investigate deviations during validation activities and implement Corrective and Preventive Actions (CAPA).
• Responsible for In-Process Quality Assurance (IPQA) activities to ensure manufacturing operations comply with cGMP and regulatory requirements.
• Perform line clearance, in-process checks, and stage-wise inspection during manufacturing and packaging operations.
• Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and other GMP documents to ensure accuracy and compliance.
• Monitor critical process parameters, environmental conditions, and utilities to maintain product quality and process integrity.
• Handle deviations, change control, investigations, and implement Corrective and Preventive Actions (CAPA).
• Ensure proper documentation practices and compliance with Quality Management System (QMS) requirements.
• Support internal audits, regulatory inspections, and customer audits, ensuring timely closure of observations.
• Coordinate with production, engineering, and regulatory teams to resolve quality issues and improve manufacturing processes.
• Contribute to continuous improvement initiatives to enhance operational efficiency and product quality.

Greenfield Project Experience – Vaccine Manufacturing Facility

• Successfully participated in two greenfield projects (Rabies Vaccine Facility and Corona Project Facility) for vaccine manufacturing facilities, supporting end-to-end qualification, validation, and regulatory compliance activities.
• Involved in facility design review, equipment selection, and layout planning to ensure compliance with cGMP and regulatory requirements.
• Executed qualification of critical equipment and utilities including HVAC systems, purified water systems, clean steam, compressed air, and manufacturing equipment.
• Prepared and executed DQ, IQ, OQ, and PQ protocols for equipment, utilities, and facility systems.
• Conducted aseptic process simulation (media fill studies) for sterile vaccine manufacturing operations.
• Performed cleanroom qualification and environmental monitoring program implementation.
• Involved in process validation and cleaning validation for vaccine production processes.
• Prepared and reviewed validation protocols, reports, and documentation in compliance with cGMP and regulatory guidelines.
• Coordinated with engineering, production, and quality teams to ensure timely completion of project activities.
• Supported regulatory inspections and audit readiness during commissioning of the vaccine facility.

About the Company

Chiron Behring Limited is a leading biotechnology and vaccine manufacturing company based in Ankleshwer, Gujarat, India. Established in 1989, the company specializes in the development and production of high-quality rabies vaccines and plays an important role in global rabies prevention programs. The company’s flagship anti-rabies vaccine, previously marketed as Rabipur has been widely used worldwide and is supported by extensive clinical research and safety data.

Job Profile / Key Responsibilities (Manufacturing)

• Handling and maintenance of primary cell cultures under controlled laboratory conditions.
• Performing aseptic handling and aseptic techniques to ensure contamination-free operations during cell culture and processing activities.
• Preparation, review, and implementation of Standard Operating Procedures (SOPs) in compliance with cGMP guidelines.
• Preparation, documentation, review and implementation of Batch Manufacturing Records (BMR), Batch Packing Record (BPR) and other related production records.
• Preparation and management of cGMP documentation, ensuring accuracy, traceability, and regulatory compliance.
• Ensuring adherence to quality standards, documentation practices, and regulatory requirements during all laboratory and manufacturing activities.
• Supporting quality systems through proper documentation, record maintenance, and compliance monitoring.