
**Product Compliance Expert
2 weeks ago
Job Title: Quality Assurance Specialist
The selected candidate will be responsible for ensuring the quality and compliance of our products with regulatory guidelines. This includes reviewing site compliance, preparing validation protocols, and reporting on product quality.
Responsibilities:
- Collate and review work plans to ensure timely response to regulatory authorities.
- Review and prepare Master Validation protocols for execution and submission.
- Verify annual product quality review reports for completeness and accuracy.
- Coordinate with auditors and site teams for regulatory inspections and audits.
- Prepare final drafts of compliance reports and check for adherence to cGMP requirements.
- Collect and review raw data for timely submission of MHRA documents.
- Drive continuous improvement initiatives in CQA.
- Execute errorless submissions by reviewing product licenses and certificates.
Requirements:
- Strong understanding of cGMP and regulatory guidelines.
- Excellent communication and coordination skills.
- Ability to drive continuous improvement initiatives.
Benefits:
- Opportunity to work with a dynamic team.
- Chance to develop skills in quality assurance.
- Competitive compensation package.
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