Job Title: Assistant Manager / Head of Department – Quality Assurance (QA)

Experience: 7–8 Years

Location:Ahmedabad

Industry: Pharmaceuticals – OSD / Liquid Formulations

Role Overview

We are seeking a dynamic and experienced professional to lead and manage the Quality Assurance (QA) function. The incumbent will be responsible for ensuring strict compliance with GMP, regulatory guidelines, and company SOPs, while managing QMS, IPQA, deviation handling, change control, and batch release activities across OSD and Liquid dosage forms.

Key Responsibilities

• Develop, implement, and monitor Quality Management Systems (QMS) in line with regulatory requirements.
• Prepare, review, and approve SOPs, protocols, and quality documents.
• Ensure effective execution of In-Process Quality Assurance (IPQA) across OSD and liquid manufacturing units.
• Manage change control, deviation handling, CAPA implementation, and risk assessments.
• Oversee batch release process in compliance with cGMP and internal quality standards.
• Conduct internal audits, self-inspections, and regulatory compliance checks.
• Ensure adherence to regulatory guidelines (USFDA, MHRA, WHO, etc.).
• Provide training to cross-functional teams on QA systems, GMP practices, and SOP adherence.
• Lead and mentor QA team members to achieve departmental objectives.

Key Skills & Competencies

• Strong knowledge of QMS, SOP drafting/review, IPQA, and batch release processes.
• Hands-on experience in OSD and Liquid formulation QA functions.
• Expertise in change control, deviation, investigation, and CAPA management.
• Familiarity with global regulatory requirements (USFDA, EU, WHO, etc.).
• Strong leadership, analytical, and decision-making skills.
• Excellent communication and documentation abilities.

Qualification

• M. Pharma / B. Pharma with 7–8 years of experience in Quality Assurance (OSD / Liquid formulations).