29 Aug
|
GELIKAPS LIFESCIENCES LTD "formerly known as Dinesh Remedies
|
Padra
29 Aug
GELIKAPS LIFESCIENCES LTD "formerly known as Dinesh Remedies
Padra
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 robust 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
📌 Head of Quality Assurance (Padra)
🏢 GELIKAPS LIFESCIENCES LTD "formerly known as Dinesh Remedies
📍 Padra