Senior Quality Assurance Specialist

Overview

LifeCell International Pvt. Ltd., located in Chennai, is seeking a seasoned Senior Quality Assurance professional to uphold compliance with Quality Management Systems (QMS), Good Manufacturing Practices (GMP), and applicable regulatory standards. The ideal candidate will possess extensive practical experience in Clean Room operations along with quality assurance tasks within pharmaceutical, biotechnology, medical device, or cell therapy sectors.

Core Responsibilities

• Evaluate and authorize QA documentation, Standard Operating Procedures (SOPs), protocols, batch records, and reports.
• Ensure adherence to QMS, GMP, Good Laboratory Practice (GLP), Good Distribution Practice (GDP), and regulatory norms.
• Supervise Clean Room activities, reinforcing GMP compliance and contamination control protocols.
• Analyze environmental monitoring results and facilitate activities involving clean room qualification and validation.
• Manage Corrective and Preventive Actions (CAPA), deviations, change controls, investigations of Out of Specification (OOS) and Out of Trend (OOT) results, and perform risk assessments.
• Coordinate and lead various audits including internal, external, customer-driven, and regulatory inspections.
• Support qualification and validation of equipment, utilities, and clean room environments.
• Guarantee documentation aligns with Good Documentation Practices (GDP).
• Deliver GMP and quality compliance training to personnel.
• Collaborate across Production, Quality Control, Engineering, and Regulatory Affairs departments to uphold quality standards.
• Promote continuous improvements in processes and maintain readiness for audits.

Qualifications and Experience

• Master's degree in Biotechnology, Pharmacy (M.Pharm), or related Life Sciences field.
• 3 to 6 years of experience in Quality Assurance roles.
• Essential hands-on expertise in Clean Room operations.
• Familiarity with QMS, GMP, GLP, GDP, CAPA, deviation handling, change control, validation techniques, and risk management.
• Preferred background in pharmaceutical, biotechnology, medical device, or cell therapy industries.

Key Skills

• Comprehensive knowledge of quality systems including QMS, GMP, GLP, GDP, CAPA, deviation and change control processes, and risk management principles.
• Understanding of Clean Room classification, environmental monitoring, and contamination control procedures aligned with GMP.
• Proficient documentation, analytical thinking, and communication skills.
• Strong problem-solving aptitude and ability to work effectively across multiple teams.
• Capacity to independently manage tasks while adhering to regulatory standards.

Additional Information

Location details: Two office addresses are provided – one in Kelambakkam on the Kelambakkam-Vandalur Road, and one in T. Nagar, Chennai.

Interested candidates may contact Siva at 7826802077 for application details.