Chemist

Care Group; Padra; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Care Group in India invites a senior QA professional to lead quality assurance activities across pharmaceutical/medical device operations. The role requires extensive experience in GMP/GDP, QMS, and regulatory-aligned documentation, with oversight of SOPs, BMR/BPR, and finished product release.

The ideal candidate will manage qualification and validation of equipment and processes, including DQ/IQ/OQ/PQ, and ensure robust CAPA/Change Control, risk management, and trend analysis.

Qualifications

• B.Pharm / M.Pharm / M.Sc or equivalent qualification.
• 45 years of QA experience in the pharmaceutical or medical device industry.
• Strong knowledge of GMP, GDP and QMS requirements.
• Experience in preparation, review and control of SOPs and other QA documents.
• Experience in BMR/BPR review and finished product release.
• Experience in qualification and validation of equipment and areas, including DQ, IQ, OQ and PQ, as applicable.
• Experience in process validation and media fill validation.
• Knowledge of calibration and validation activities.
• Knowledge of Change Control, Deviation, CAPA and Risk Management.
• Experience or knowledge of APQR/PQR, complaint handling, PMS and trend analysis.
• Good documentation and communication skills.
• Should be detail-oriented and able to ensure compliance with approved procedures and GMP requirements.

Skills

GMP knowledge

GDP knowledge

QMS requirements

SOPs & QA docs

BMR/BPR review

Qualification & validation

Process validation

CAPA & Change Control

Education

B.Pharm / M.Pharm / M.Sc or equivalent qualification

Job description

• B.Pharm / M.Pharm / M.Sc. or equivalent qualification.
• 45 years of experience in Quality Assurance in the pharmaceutical or medical device industry.
• Good knowledge of GMP, GDP and Quality Management System requirements.
• Experience in preparation, review and control of SOPs and other QA documents.
• Experience in BMR/BPR review and finished product release.
• Experience in qualification and validation of equipment and areas, including DQ, IQ, OQ and PQ, as applicable.
• Experience in process validation and media fill validation.
• Knowledge of calibration and validation activities.
• Knowledge of Change Control, Deviation, CAPA and Risk Management.
• Experience or knowledge of APQR/PQR, complaint handling, PMS and trend analysis.
• Good documentation and communication skills.
• Should be detail-oriented and able to ensure compliance with approved procedures and GMP requirements.