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.
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 capsule joining operations/process.
- Strong practical knowledge of GMP, Pharmaceutical Quality Systems, CAPA, deviations, OOS/OOT, validation, change control, risk management, and audits.
- Proven leadership and team-management experience.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline.
- Experience in handling regulatory, customer, and GMP audits will be highly preferred.
- Candidates who can join within one month will be preferred.
Location & Employment
Location: Padra, Gujarat, India
Work Mode: On-site
Employment Type: Full-time
⏳ Expected Joining: Within 1 Month
Interested?
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.
Please share your updated CV along with your current CTC, expected CTC, notice period, and interview availability at .
Only candidates with relevant capsule-manufacturing and joining experience will be considered.
GELIKAPS LIFESCIENCES LTD
- Formerly known as Dinesh Remedies Limited