
Senior Compliance Associate
7 days ago
Job Summary
- This is an exciting opportunity for a Quality Assurance professional to join our organization in the role of Sr. Associate, QA Compliance. The successful candidate will be responsible for ensuring the implementation and maintenance of Quality Management System elements at our site.
The Sr. Associate, QA Compliance will be responsible for achieving compliance with global quality metrics and submitting quality metrics data to the QA Head and management on time. This includes tracking and implementing improvement objectives identified during quality metrics presentations.
In addition, the successful candidate will evaluate departmental efficiency and ensure required training for cross-functional team members is provided. They will also assist the QA Head in implementing Electronic Quality Management System (E-QMS) modules to handle QMS elements effectively across the plants.
Key Responsibilities- Quality Management: Ensure non-conformities (NCR/SNCRs) are adequately investigated, root causes identified, and effective Corrective and Preventive Actions (CAPA) are implemented.
- Review and Approval: Review and approve Out of Specifications (OOS) results, ensuring timely assessment for Field Alert Report (FAR) or regulatory actions.
- Laboratory Investigation Reports (LIR): Ensure Out of Trend (OOT), Out of Limit (OOL), and Laboratory Investigation Reports (LIR) are adequately investigated.
- Change Control Management (CCM): Review and approve Change Control Management (CCM) and Document Change Requests (DCR) as per Standard Operating Procedures.
- Monitoring and Reporting: Monitor and ensure key performance indicators are maintained periodically and achieved.
- Data Reliability: Ensure data reliability is in place.
- Site Management Reviews: Conduct site management reviews, NCR, OOS/OOT/OOL, and Change Control review meetings on time.
- CAPA Review Board Meetings: Attend CAPA review board meetings and monthly quality metrics review meetings on time.
- External and Internal Audits: Support external and internal audits at the site, providing observations related to QMS compliance.
- Communication: Communicate cross-functional requirements to concerned personnel and functions.
To succeed in this role, you will need strong analytical and problem-solving skills, as well as excellent communication and interpersonal skills. You should have a solid understanding of Quality Management Systems and experience in auditing and inspection.
BenefitsWe offer a competitive salary and benefits package, including opportunities for career growth and professional development.
OthersIf you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
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