> Role Objective:

A key objective of this position is to lead and govern the Quality function at the manufacturing site, ensuring uncompromised product quality, patient safety, and compliance with global regulatory requirements (USFDA, EU-GMP, MHRA, WHO-GMP, TGA, and other regulated markets) across sterile injectable operations. The role is responsible for building a robust Quality Management System, driving a strong quality culture, ensuring inspection readiness, and enabling business continuity through consistent, compliant, and right-first-time manufacturing and testing of injectable products.

> Desired Candidate Profile:

- B.Pharm / M.Pharm / M.Sc. (Chemistry or Microbiology) or equivalent; a Ph.D. or additional certification in Quality/Regulatory Affairs will be an added advantage.
- 18 to 22 years of progressive experience in Quality Assurance/Quality Control, with a mandatory and demonstrable background in pharma injectable (sterile/parenteral) manufacturing vials, ampoules, PFS, lyophilized products, or biologics.
- Prior experience of successfully hosting and clearing regulatory inspections (USFDA, EU-GMP, MHRA, WHO, ANVISA, etc.) at an injectable facility.
- Proven track record in leading site quality operations for a large-scale, high-volume sterile manufacturing plant.
- Strong exposure to aseptic processing, isolator/RABS technology, media fill validation, and environmental monitoring programs.
- Demonstrated leadership in managing large, multi-level quality teams (QA, QC, Microbiology, Validation, Regulatory Compliance).
- Excellent stakeholder management skills with the ability to interface with regulators, corporate quality, and site leadership.

> Roles & Responsibilities:

- Provide strategic leadership to the site Quality function (QA, QC, Microbiology, Validation, and Documentation) in line with corporate quality objectives.
- Own and drive the site Quality Management System (QMS), ensuring alignment with global GMP/GDP standards.
- Set annual quality objectives, KPIs,



and improvement plans for the site.
- Ensure regulatory compliance and inspection readiness for all applicable health authorities.
- Lead preparation for and hosting of USFDA, EU-GMP, MHRA, WHO-GMP, and other customer/regulatory audits.
- Ensure timely closure of audit observations, CAPAs, and warning letter responses, where applicable.
- Govern quality systems specific to sterile/injectable manufacturing.
- Oversee aseptic process validation, media fills, environmental monitoring, and sterility assurance programs.
- Ensure robust control over deviations, OOS/OOT, change controls, CAPA, and market complaints.
- Drive Quality Risk Management across manufacturing, packaging, and laboratory operations.
- Implement risk-based approaches (QRM/ICH Q9) for critical process and product quality attributes.
- Lead validation and qualification programs.
- Ensure equipment, utility, process, and cleaning validations are executed and maintained in a validated state.
- Build and mentor a high-performing Quality organization.
- Develop talent, succession plans, and training programs to strengthen quality capability at the site.
- Partner with cross-functional teams (Manufacturing, Engineering, Supply Chain, Regulatory Affairs) to ensure quality is embedded across the value chain.
- Report site quality performance, risks, and compliance status to senior leadership and corporate quality on a periodic basis.

> Functional Skills Required:

- In-depth knowledge of cGMP, GLP, GDP, and global regulatory guidelines (USFDA, 21 CFR 211, EU Annex 1, ICH Q7-Q10).
- Strong command of sterile/injectable manufacturing processes aseptic filling,



lyophilization, terminal sterilization, and container closure integrity.
- Expertise in Quality Management Systems: deviations, CAPA, change control, OOS/OOT investigations, and complaint management.
- Sound knowledge of validation and qualification (process, cleaning, equipment, computer system validation).
- Experience with data integrity requirements (ALCOA+) and computerized system compliance (21 CFR Part 11).
- Working knowledge of Quality Risk Management tools (FMEA, HACCP, QRM as per ICH Q9).
- Proficiency in handling regulatory audits, customer audits, and corporate quality reviews independently.
- Familiarity with statistical tools and trending techniques for quality data analysis.

> Behavioral Skills Required:

- Strong leadership and people management capability to lead large, cross-functional teams.
- High integrity and uncompromising commitment to quality and patient safety.
- Excellent communication and interpersonal skills to engage with regulators, senior management, and cross-functional stakeholders.
- Sound decision-making and problem-solving ability, especially under regulatory and business pressure.
- Strategic thinking combined with hands-on execution capability.
- Resilience, composure, and the ability to manage crisis situations (e.g., audits, recalls, market complaints) effectively.
- Robust ownership, accountability, and a continuous improvement mindset.

> Team Size to be Handled:

- Reports to: VP Quality.
- Team Structure: 30 - 35 Quality professionals, including 3-4 direct reportees at the Sr. Manager and Manager levels

> Important Links:

Website: https://biotechhealthcare.com/

LinkedIn: https://www.linkedin.com/company/biotechhealthcare/

Instagram: Biotech Vision Care

Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.

📌 General Manager Quality (Gujarat)
🏢 Biotech Vision Care
📍 Gujarat