Job Summary

Position: Executive/Asst. Manager - QA

Location

Location: Silvassa

Experience

Experience: 2 - 10 Years

Industries

Industries: Pharma

Responsibilities

- Ensure compliance with GMP, regulatory guidelines, and quality standards in pharmaceutical formulation manufacturing.
- Manage quality systems, audits, documentation, validations, and batch release while leading the QA team.
- Implement and maintain Quality Management Systems (QMS) as per USFDA, WHO-GMP, MHRA, and EU-GMP.
- Oversee deviation management, CAPA, change control, and OOS/OOT investigations.
- Conduct and lead regulatory and customer audits and ensure compliance with audit observations.
- Manage process validation, cleaning validation, and analytical method validation as per regulatory standards.
- Maintain data integrity and ensure compliance in reviewing BMR, BPR, COA, and stability studies.
- Handle vendor qualification, supplier audits, and raw material compliance.




- Lead customer complaint handling, market recalls, and root cause investigations.
- Provide GMP training, mentoring, and development of the QA team to drive quality excellence.
- Ensure effective coordination with cross-functional teams to maintain quality standards across production and QC.

Required Skills
- Robust knowledge of regulatory compliance, quality risk management, and audit handling.
- Expertise in QMS, validation processes, and documentation review.
- Excellent leadership, problem-solving, and communication skills.
- Exposed to regulatory audits.
- Exposed with Sterile / Non-sterile products formulations.
- SAP is must

Qualifications Required Qualification: B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry

Key Skills

- Qa
- Manager

📌 Executive/Asst. Manager - QA (Dadra)
🏢 Quality HR Services
📍 Dadra