Job Description:

Position: Dy. Manager - Quality

Location: Vapi

Experience: 8 - 10 Years

Industries: Pharma API

Responsibilities:
- Quality Management System (QMS)

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Establish, implement, and maintain an effective Quality Management
- System in line with cGMP, ICH, USFDA, EU-GMP, WHO, and other regulatory requirements.
- Ensure compliance with SOPs, policies, and regulatory guidelines across manufacturing, QC, and support functions.
- Review and approve SOPs, protocols, validation documents, and quality records.
- Regulatory Compliance & Audits
- Lead regulatory inspections and customer audits (USFDA, MHRA, WHO, ANVISA, etc.).
- Ensure audit readiness of the facility at all times.
- Review observations, prepare responses, and ensure timely CAPA implementation and closure.
- Deviation, CAPA & Risk Management
- Oversee investigations related to deviations, OOS, OOT, complaints, and incidents.
- Ensure root cause analysis and effectiveness of corrective and preventive actions.
- Manage change control and risk assessment activities.
- Product Quality & Validation




- Ensure execution and review of Process Validation, Cleaning Validation, Equipment Qualification, and Analytical Method Validation.
- Review and approve Product Quality Review (PQR/APQR).
- Ensure lifecycle management of products and processes.
- Team Leadership & Training
- Lead, mentor, and develop the Quality team.
- Ensure training on GMP, data integrity, and quality systems for all employees.
- Conduct performance reviews and competency development.
- Data Integrity & Continuous Improvement
- Ensure compliance with Data Integrity principles (ALCOA+).
- Drive quality improvement initiatives and promote a quality culture.
- Implement quality metrics and management review processes.
- Cross-Functional Coordination
- Collaborate with Production, Engineering, Warehouse, Supply Chain, Regulatory Affairs, and R&D.;
- Support current product introductions, technology transfers, and regulatory submissions.

Requ

📌 Dy. Manager (Vapi)
🏢 Quality HR India
📍 Vapi