Manager – QA (Kosamba Unit)

Department: Quality Assurance

Location: Kosamba

Qualification: B.Sc./M.Sc./B.Pharm

Experience: 8–15 years

Job Responsibilities

- Act as QA In-charge for the plant.
- Drive Quality KPIs.
- Lead QA documentation, CAPA, deviations, change control, risk assessments and validation review.
- Coordinate customer, internal and regulatory audits.
- Ensure compliance with GMP, cGMP, ISO 9001 principles and applicable regulatory requirements.
- Review SOPs, BMR/BPR, specifications and quality records.
- Support qualification/validation activities.
- Train employees on GMP, GDP and quality systems.
- Lead continuous improvement and inspection readiness.

Core Functional Competencies

- Solid knowledge of QA systems, documentation, GMP/cGMP, GDP and ISO standards.
- Expertise in CAPA, deviation, OOS/OOT investigation, change control and risk management.
- Internal/external audit planning, execution and compliance monitoring.
- Regulatory inspection handling and root cause analysis.

Behavioral Competencies

- Leadership and team management.
- Cross-functional collaboration.
- Strong communication and decision-making.
- Analytical thinking, problem solving and proactive quality culture.

📌 Manager – QA (Kosamba Unit) (India)
🏢 Talent Vision Services
📍 India