Quality Assurance Specialist

About the Role: Executive – Quality Assurance

Responsibilities:

• Management and control of document, Quality assurance procedure & SOPs.
• Control, Review and issuance of work instructions, SOPs, QSPs & artwork etc.
• Preparation and review of procedure, QSPs, qualification and validation protocol.
• Preparation and analysis of quality trends.
• Handling of change control management system and non-conformity of product.
• Conduct internal audit, supplier quality audit and support in external audit.
• Review of correction, corrective action and preventive action including effectiveness monitoring.
• Review and follow-up with internal department for external and internal calibrations as per schedule.
• Review/approve of proof check, print proof and artwork.
• Review the batch manufacturing Record.
• Provide training related to GMPs, QSPs, SOPs etc.
• Communicate and update the work instructions.
• Support in the investigation of non-conformity and market complaint.
• Collect the data for management review meeting & data analysis.
• Review of all quality test reports, printing specification and trends.
• Provide training to Microbiological procedure, GLP, QSPs, SOPs, GMP etc.
• Responsibility to review and release of batch release.

Qualifications: Pharmacy, Biotechnology, Life Sciences preferred

Required Skills:

• Technical files as per the requirement of EUMDR
• Preparing Technical files as per the requirement of MDD and ensure the compliance with the MDD requirements for class I, IIa, IIb and class III medical devices
• Preparation and review of Design History File, Clinical Evaluation Report, PMS Report, PSUR, PMCF report etc.

Pay range and compensation package: Full time

Equal Opportunity Statement: We are committed to diversity and inclusivity.