Job Title: Senior QA

Company: LifeCell International Pvt. Ltd.

Location: Chennai

Experience: 36 Years

Job Summary

LifeCell International Pvt. Ltd. is seeking an experienced Senior QA to ensure compliance with Quality Management Systems (QMS), GMP requirements, and regulatory standards. The ideal candidate should have hands-on experience in Clean Room operations and quality assurance activities within the pharmaceutical, biotechnology, medical device, or cell therapy industry.

Key Responsibilities

- Review and approve QA documents, SOPs, protocols, reports, and batch records.
- Ensure compliance with Quality Management System (QMS), GMP, GLP, GDP, and regulatory requirements.
- Monitor and maintain Clean Room operations, ensuring compliance with GMP and contamination control requirements.
- Review environmental monitoring data and support clean room qualification and validation activities.
- Handle CAPA, deviations, change controls, OOS/OOT investigations, and risk assessments.
- Plan and coordinate internal, external, customer, and regulatory audits.
- Support equipment, utility, and clean room qualification and validation activities.
- Ensure documentation complies with Positive Documentation Practices (GDP).




- Conduct GMP and quality compliance training for employees.
- Collaborate with Production, QC, Engineering, and Regulatory Affairs teams to ensure quality standards are maintained.
- Drive continuous process improvements and maintain audit readiness.

Qualifications

- Master's Degree in Biotechnology, M.Pharm, or a related Life Sciences discipline.

Experience

- 3 to 6 years of experience in Quality Assurance.
- Hands-on experience in Clean Room operations is mandatory.
- Experience in handling QMS, GMP, GLP, GDP, CAPA, Deviations, Change Control, Validation, and Risk Management.
- Experience in pharmaceutical, biotechnology, medical device, or cell therapy industries is preferred.

Skills Required

- Strong knowledge of QMS, GMP, GLP, GDP, CAPA, Deviations, Change Control, and Risk Management.
- Good understanding of Clean Room classifications, environmental monitoring, contamination control, and GMP compliance.
- Excellent documentation, analytical, and communication skills.
- Strong problem-solving and cross-functional collaboration abilities.
- Ability to work independently while ensuring regulatory compliance.

Apply Now

Siva

(phone hidden)

📌 Senior - Quality Assurance (Chennai)
🏢 Lifecell
📍 Chennai