Head of Quality Assurance

GELIKAPS LIFESCIENCES LTD "formerly known as Dinesh Remedies Limited"; Padra; On-site; INR 2,800,000 - 5,200,000; Full time

Job summary

GELIKAPS LIFESCIENCES LTD, formerly Dinesh Remedies Limited, is seeking a Head – Quality Assurance to lead the QA function and drive GMP compliance, product quality, and regulatory adherence across our capsule manufacturing operations.

The ideal candidate has 10+ years in QA/QMS within pharma/nutraceutical manufacturing, with expertise in audits, CAPA, deviations, validation, and risk management. The role requires strong leadership and collaboration with Production, Regulatory, and R&D teams.

Qualifications

• 10+ years of QA/Quality Management experience in pharma/nutrition/commercial manufacturing.
• Experience with empty hard gelatin capsule manufacturing is a plus.

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 GMP documentation (BMRs/BPRs, SOPs, specs, validation reports).
• Manage deviations, OOS/OOT investigations, CAPA, change controls, complaints, risk assessments, and PQRs.
• Oversee process validation, cleaning validation, equipment qualification, analytical method validation, and related quality activities.
• Ensure effective vendor qualification and monitoring of critical materials.
• Lead audits by customers, regulators, GMP bodies, and certifications; coordinate responses and closure of observations.

Skills

GMP expertise

PQS

Audits

Validation

CAPA

Deviations

OOS/OOT

Change control

Risk management

Regulatory compliance

Education

Bachelor’s or Master’s in Pharmacy, Chemistry, Life Sciences

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.

• The ideal candidate will have 10+ years of relevant experience in Quality Assurance/Quality Management within the pharmaceutical, nutraceutical, or related manufacturing industry, with strong expertise in GMP, Pharmaceutical Quality Systems, audits, validation, CAPA, deviations, OOS/OOT, change control, risk management, and regulatory compliance.

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.

• The ideal candidate will have 10+ years of relevant experience in Quality Assurance/Quality Management within the pharmaceutical, nutraceutical, or related manufacturing industry, with strong expertise in GMP, Pharmaceutical Quality Systems, audits, validation, CAPA, deviations, OOS/OOT, change control, risk management, and regulatory compliance.

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 in pharmaceutical, nutraceutical, or related manufacturing.
• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related discipline.
• Strong practical knowledge of GMP, PQS, CAPA, deviations, OOS/OOT, validation, change control, risk management, and audits.
• Proven leadership and team-management experience.
• Experience in empty hard gelatin capsule manufacturing will be an added advantage.