AGM -QA Head
- Rusan Pharma
- 15 - 20 years
- Kandla
- 6 months ago
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Job Description
Key Responsibilities
- Lead and manage the Quality Assurance department, ensuring compliance with GMP norms and regulatory requirements of WHO, EU GMP, PICS, TGA, MHRA, USFDA, and other global agencies.
- Develop, implement, and monitor Quality Management Systems (QMS) across all QA functions.
- Ensure strict adherence to SOPs and continuous improvement practices in line with regulatory expectations.
- Oversee handling of rejected materials, market complaints, product recalls, deviations, change controls, CAPA, and CCF.
- Manage end-to-end Validation and Qualification activities (process validation, cleaning validation, equipment qualification, analytical method validation, etc.).
- Ensure audit readiness at all times and lead regulatory/customer audits and inspections.
- Review, approve, and monitor the control of documents, records, and quality risk management systems.
- Provide leadership and guidance to QA teams, including training, mentoring, and performance monitoring.
- Collaborate with cross-functional teams (Production, QC, R&D, Regulatory Affairs) to maintain high-quality standards.
- Drive initiatives for continuous quality improvement and compliance to ensure products meet global regulatory expectations.
Desired Candidate Profile
- B.Pharm / M.Pharm with 1520 years of proven experience in Quality Assurance of Pharma Formulation Units.
- Strong command over WHO GMP, EU GMP, PICS, TGA, MHRA, and USFDA regulatory guidelines.
- Expertise in handling market complaints, investigations, and product recalls.
- Thorough knowledge of CAPA, deviations, and change control processes.
- In-depth experience in validation & qualification activities.
- Excellent leadership, decision-making, and cross-functional coordination skills.
- Strong communication skills with the ability to face regulatory and customer audits confidently.
- Willingness to relocate to Gandhidham.
- Candidates who can join immediately will be given preference.
Compensation & Benefits
- Competitive salary aligned with industry standards.
- Relocation support for suitable candidates.
- Opportunity to head the QA function and drive strategic quality initiatives for a regulated market facility.Role & responsibilities
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: Rusan PharmaLocation(s): Kandla
Keyskills: Pharma Formulations QA Leadership EU GMP Tablets Product Recalls Market Complaint PICS Regulatory Compliance MHRA TGA USFDA Equipment Formulation Injectables Handling Rejected Material WHO
Rusan Pharma
Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its Corporate office at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing ...
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