10 Sep
|
GELIKAPS LIFESCIENCES LTD "formerly known as Dinesh Remedies
|
Vadodara
10 Sep
GELIKAPS LIFESCIENCES LTD "formerly known as Dinesh Remedies
Vadodara
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.
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 within the pharmaceutical, nutraceutical, or related manufacturing industry.
- Mandatory: Hands-on experience in Empty Hard Gelatin Capsule Manufacturing.
- Mandatory: Practical experience in caps
📌 Head Of Quality Assurance (Vadodara)
🏢 GELIKAPS LIFESCIENCES LTD "formerly known as Dinesh Remedies
📍 Vadodara