GELIKAPS LIFESCIENCES LTD , formerly known as Dinesh Remedies Limited, is a GMP-certified manufacturer of Empty Hard Gelatin Capsules serving the pharmaceutical, nutraceutical, herbal, and healthcare industries.

We are looking for an experienced Head – Quality Assurance to lead our QA function and ensure the highest standards of GMP compliance, product quality, regulatory compliance, and continuous improvement across our manufacturing operations.

- The ideal candidate will have 10+ years of relevant experience in Quality Assurance/Quality Management within the pharmaceutical, nutraceutical, or related manufacturing industry, with solid expertise in GMP, Pharmaceutical Quality Systems, audits, validation, CAPA, deviations, OOS/OOT, change control, risk management, and regulatory compliance .

Key Responsibilities
- Lead QA operations for empty hard gelatin capsule manufacturing .
- Ensure GMP compliance across manufacturing and support functions.
- Provide QA oversight of gelatin preparation, dipping, drying, stripping, trimming, joining, printing, sorting, inspection, and packing processes .
- Review and approve BMRs/BPRs, SOPs, specifications, validation protocols, reports, and other GMP documentation .
- Manage deviations, OOS/OOT investigations, CAPA, change controls, complaints, risk assessments, and Product Quality Reviews .




- Oversee process validation, cleaning validation, equipment qualification, analytical method validation, and related quality activities .
- Ensure effective vendor qualification and monitoring of critical raw materials and packaging materials.
- Lead customer, regulatory, GMP, and certification audits , including preparation, response, and closure of observations.
- Monitor quality KPIs, rejection trends, complaints, deviations, CAPA effectiveness, and other quality metrics.
- Work closely with Production, QC, Engineering, R&D;, Warehouse, and Regulatory teams to resolve quality issues and improve processes.
- Develop, mentor, and lead the QA team while strengthening the organization's GMP and quality culture .

Qualifications & Experience
- 10+ years of relevant experience in QA/Quality Management in pharmaceutical, nutraceutical, or related manufacturing.
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related discipline .
- Strong practical knowledge of GMP, PQS, CAPA, deviations, OOS/OOT, validation, change control, risk management, and audits .
- Proven leadership and team-management experience.
- Experience in empty hard gelatin capsule manufacturing will be an added advantage.

📌 Head of Quality Assurance (Padra)
🏢 Gelikaps lifesciences
📍 Padra