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. /n 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. /n Key Responsibilities /n /n
- Lead QA operations for empty hard gelatin capsule manufacturing.
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- Ensure GMP compliance across manufacturing and support functions.
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- Provide QA oversight of gelatin preparation, dipping, drying, stripping, trimming, joining, printing, sorting, inspection, and packing processes.
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- Review and approve BMRs/BPRs, SOPs, specifications, validation protocols, reports, and other GMP documentation.
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- Manage deviations, OOS/OOT investigations, CAPA, change controls, complaints, risk assessments, and Product Quality Reviews.
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- Oversee process validation, cleaning validation, equipment qualification, analytical method validation, and related quality activities.
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- Ensure effective vendor qualification and monitoring of critical raw materials and packaging materials.
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- Lead customer, regulatory, GMP, and certification audits, including preparation, response, and closure of observations.
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- Monitor quality KPIs, rejection trends, complaints, deviations, CAPA effectiveness, and other quality metrics.
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- Work closely with Production, QC, Engineering, R&D;, Warehouse,
and Regulatory teams to resolve quality issues and improve processes.
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- Develop, mentor, and lead the QA team while strengthening the organization's GMP and quality culture.
/n /n Qualifications & Experience /n /n
- 10+ years of relevant experience in QA/Quality Management within the pharmaceutical, nutraceutical, or related manufacturing industry.
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- Mandatory: Hands-on experience in Empty Hard Gelatin Capsule Manufacturing.
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- Mandatory: Practical experience in capsule joining operations/process.
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- Robust practical knowledge of GMP, Pharmaceutical Quality Systems, CAPA, deviations, OOS/OOT, validation, change control, risk management, and audits.
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- Proven leadership and team-management experience.
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- Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline.
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- Experience in handling regulatory, customer, and GMP audits will be highly preferred.
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- Candidates who can join within one month will be preferred.
/n /n Location & Employment /n Location: Padra, Gujarat, India /n Work Mode: On-site /n Employment Type: Full-time /n Expected Joining: Within 1 Month /n Interested? /n If you meet the above requirements and have hands-on experience in empty hard capsule manufacturing and capsule joining, we would like to hear from you. /n Please share your updated CV along with your current CTC, expected CTC, notice period, and interview availability at
[email protected]. /n Only candidates with relevant capsule-manufacturing and joining experience will be considered. /n GELIKAPS LIFESCIENCES LTD /n /n
- Formerly known as Dinesh Remedies Limited
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📌 Head of Quality Assurance (Jamnagar)
🏢 Gelikaps lifesciences
📍 Jamnagar