12 Sep
|
GELIKAPS LIFESCIENCES LTD "formerly known as Dinesh Remedies
|
Anastu
12 Sep
GELIKAPS LIFESCIENCES LTD "formerly known as Dinesh Remedies
Anastu
Job Description
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.
nWe 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.
nKey Responsibilities
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- Lead QA operations for empty hard gelatin capsule manufacturing.n
- Ensure GMP compliance across manufacturing and support functions.n
- Provide QA oversight of gelatin preparation, dipping, drying, stripping, trimming, joining, printing, sorting, inspection, and packing processes.n
- Review and approve BMRs/BPRs, SOPs, specifications, validation protocols, reports, and other GMP documentation.n
- Manage deviations, OOS/OOT investigations, CAPA, change controls, complaints, risk assessments, and Product Quality Reviews.n
- Oversee process validation, cleaning validation,
equipment qualification, analytical method validation, and related quality activities.n
- Ensure effective vendor qualification and monitoring of critical raw materials and packaging materials.n
- Lead customer, regulatory, GMP, and certification audits, including preparation, response, and closure of observations.n
- Monitor quality KPIs, rejection trends, complaints, deviations, CAPA effectiveness, and other quality metrics.n
- Work closely with Production, QC, Engineering, R&D;, Warehouse, and Regulatory teams to resolve quality issues and improve processes.n
- Develop, mentor, and lead the QA team while strengthening the organization's GMP and quality culture.n
nQualifications & Experience
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- 10+ years of relevant experience in QA/Quality Management within the pharmaceutical, nutraceutical, or related manufacturing industry.n
- Mandatory: Hands-on experience in Empty Hard Gelatin Caps
📌 Head of Quality Assurance (Anastu)
🏢 GELIKAPS LIFESCIENCES LTD "formerly known as Dinesh Remedies
📍 Anastu