
Senior Compliance Officer
7 hours ago
The Quality Assurance Specialist plays a vital role in ensuring product quality, regulatory compliance, and continuous improvement within a regulated environment.
Main Responsibilities:- Initiate and complete technical and cost-saving activities for process improvements including risk documentation, test methods, process/software validation, and procedural updates.
- Review and approve change controls.
- Perform statistical analysis and interpret data using appropriate statistical tools and methods.
- Develop and implement effective sampling strategies.
- Write and review CAPAs, non-conformance reports (NC/NCMRs), and supplier corrective action requests (SCARs).
- Ensure ongoing compliance in Product Manufacturing, Packaging, and Labelling.
- Conduct internal and supplier audits to verify compliance.
- Support external audits by regulatory bodies (e.g., ISO, FDA).
- Collect, compile, and analyse Quality Metrics and other performance data.
- Maintain compliance with training requirements and associated documentation.
- Follow Environmental, Health and Safety (EHS) and CGMP policies and procedures.
- Contribute to the continuous improvement of compliance initiatives across the business.
Required Experience: A minimum of 3 years' experience in a regulated environment is required.
Required Skills: Strong attention to detail, strong computer proficiency, especially in MS Excel, Power Point, and Word, familiarity with statistical tools (e.g., Pareto charts, trend analysis), experience with risk management tools such as FMEAs and root cause analysis, strong problem-solving skills, clear and effective communication skills - both verbal and written, ability to work in a fast-paced, team-oriented environment, experience in change control implementation within a medical device setting, adherence to CGMP and compliance standards.
A degree-level qualification in Quality, Science, or Engineering is required. This is a team-based role requiring collaboration and adaptability.
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