Head of Quality Assurance

Gelikaps Lifesciences Ltd. "formerly known as Dinesh Remedies Limited" · India

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 kevin@gelikaps.com .

Only candidates with relevant capsule-manufacturing and joining experience will be considered.

GELIKAPS LIFESCIENCES LTD

• Formerly known as Dinesh Remedies Limited