Head - Quality Assurance

Job Description:

Position:      Head - QA

Location:      Daman

Experience:    15 - 25 Years

Industries:     Pharma

Responsibilities:

• Site Quality Leadership:
• To establish and maintain a robust Quality Management System (QMS) aligned with regulatory expectations.
• To represent the organization as the Quality Management Representative during internal, external, and regulatory inspections, ensuring successful outcomes and continuous compliance readiness.
• Quality Management System (QMS) Ownership:
• To ensure compliance of deviation management, change control, Market Complaint Recall, CAPA systems, OOS, risk assessments, and investigations with regulatory and quality standards.
• To ensure for cGMP/GLP/GDP/GEP followed by all personnel.
• To manage batch release processes, ensuring timely review and disposition in alignment with GMP requirements.
• To manage document control, master batch records, validation protocols, and ensure timely periodic reviews.
• To led continuous improvement initiatives to enhance the Quality Management System (QMS) and drive operational excellence.
• Batch Release and Product Quality Oversight
• To ensure timely review and approval of Batch Manufacturing Records, Quality Control (QC) reports, and Certificates of Analysis (COA).
• To execute QA release for commercial and validation batches, including product quality review and compliance verification.
• Training and Development 
• To establish and led training programs on GMP, GDP, Data Integrity, and regulatory updates for QA and cross functional teams.
• To build quality culture across the site through continuous learning initiatives and behaviour-based quality systems.
• FDA
• To handle FDA work preparation of documents, submission, reply and follow up supervisors.
• To collaborate with Engineering, Quality Control (QC), Regulatory Affairs, Supply Chain, and Corporate Quality teams to ensure smooth execution of compliance activities and alignment with regulatory quality standards.
• Risk Management (QRM) & Continuous Improvement
• To led Quality Risk Management (QRM) activities, including risk assessments and mitigation
• planning to proactively identify and address quality and compliance risks.
• Qualifications & Validations
• To ensure effective coordination with validation teams for timely execution of equipment qualifications, re-qualifications, and periodic reviews of OSD manufacturing equipment’s and
• Injection manufacturing equipment like Autoclave, Tunnel, Vial washing machine, Filling machine,
• Lyophilizer, Isolators and utilities like HVAC systems, Nitrogen, compress air, water system, puresteam.
• RMG, Autocoater, Compression machine, Blister machine.
• To oversee Process Validation, Cleaning Validation activities and Aseptic Process simulation compliance to ensure alignment with current regulatory expectations and cGMP standards.
• To led review and approval of Qualification Protocols, Validation Reports, SMF, and VMP to ensure compliance with regulatory standards.
• Audits and Compliance
• To led and actively participate in external regulatory audits and customer audits, serving as a key point of contact for quality and compliance matters.
• To demonstrate strong audit-facing capabilities with a proven track record in managing regulatory and customer audits, ensuring timely and effective closure of observations through robust CAPA implementation.
• In-Process Quality Systems & cGMP Compliance
• To accountable for in-process Quality Assurance (IPQA) activities across Liquid Injectable,Lyophilized Injectable, and Solid Oral Dosage manufacturing and packing areas.
• To ensure adherence to current Good Manufacturing Practices (cGMP) by proactively monitoring operations and resolving day-to-day quality and compliance issues in real time.
• Documentation, Data Control & Regulatory Compliance
• To ensure timely review and approval of key quality documents including Annual Product Quality
• Reviews (APQRs), Continued Process Verification (CPV) reports, and implementation of CAPAs where required.
• To oversaw accurate stability monitoring programs in compliance with ICH guidelines and customer-specific requirements.
• To accountable for release or rejection of raw materials, packaging materials, intermediates, and finished drug products as per approved procedures.

 Required Skills

• Logical thinking.
• Organizing.
• Good communication.

Required Qualification: - B. Pharm/M. Pharm

Salary :- Upto 22.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-