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Senior Executive Quality Assurance
2 weeks ago
Location
: Udaipur, Rajasthan
Department
: Quality Assurance
Experience Required
: 3–6 years in QA (Pharmaceuticals)
Employment Type
: Full-time
About Us
Mednext Biotech Ltd. is a WHO-GMP certified, export-oriented pharmaceutical formulations company with a global footprint across Africa, Asia, and emerging markets. We manufacture tablets, capsules, oral liquids, injectables, ointments, gels, and nutraceuticals. As we expand into better compliance metrics and new therapeutic categories, we are strengthening our Quality Assurance team to uphold the highest global standards.
Role Overview
We are seeking a Senior QA Executive who will be responsible for ensuring compliance with GMP, GDP, and global regulatory requirements across manufacturing and packaging. This role will involve oversight of in-process quality checks, documentation review, and coordination with cross-functional teams (Production, QC, RA, SCM) to ensure first-time-right operations.
Key Responsibilities
- Review and approval of Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), and logbooks.
- Oversight of line clearance, in-process checks, and IPQA during manufacturing and packing.
- Support in deviation handling, OOS/OOT investigations, CAPA implementation, and change control.
- Maintain and monitor QMS modules (document control, deviations, complaints, product recalls).
- Support in qualification and validation activities (equipment, process, cleaning, analytical).
- Preparation for regulatory audits (WHO, CDSCO, ISO, client audits) and timely closure of observations.
- Liaison with Production, QC, RA, and SCM for regulatory readiness and smooth batch release.
- Assist in drafting and reviewing SOPs, protocols, and training materials.
Qualifications & Experience
- B.Pharm / M.Pharm / M.Sc. in Chemistry, Pharmaceutical Sciences, or related field.
- 3–6 years of experience in Quality Assurance within a pharma plant.
- Strong knowledge of GMP, GDP, QMS, and documentation practices.
- Hands-on exposure to regulatory audits (WHO, CDSCO; EU-GMP exposure preferred).
- Excellent attention to detail, documentation discipline, and communication skills.
What We Offer
- Opportunity to work in a fast-growing international pharma company.
- Exposure to global regulatory standards and new market expansions (EU, Africa, Asia).
- Collaborative work culture with strong focus on quality and compliance.
- Competitive salary and performance-linked incentives.
- Company-provided bus service for convenient commute to the plant.
