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.
