Quality Assurance Specialist
4 days ago
Job Title: Quality Assurance Specialist
Company: CDM Recruitment Ltd - Life Sciences
Location: Central Belt - Glasgow/Motherwell
Job Type: Permanent
Salary: £30,000 - £35,000
About the Role:
We are seeking an experienced Quality Assurance Specialist to join our client's team on a permanent basis. The successful candidate will report directly to the QA Manager and be responsible for ensuring Quality Assurance activities relating to product support for the manufacture, packaging, testing, storage, and distribution of manufactured drug products are compliant with current Good Manufacturing Practice (GMP) and company expectations.
Key Responsibilities:
- Provide QA Input: Review and approve risk assessments, specifications, Standard Operating Procedures, and other documentation types as required.
- Review and Approve Batch Manufacturing Data: Ensure that batch manufacturing data sets are compliant with procedures for GMP, prior to passing to the Qualified Person for batch confirmation/certification. Highlight potential issues to the QA Manager.
- Participate in Investigations/Audits: Assist in the development and approval of effective Corrective and Preventive Actions (CAPAs) to resolve internal and external issues.
- Identify and Escalate GMP Areas of Concern: Ensure that all GMP areas of concern are identified and escalated to the QA Manager.
- Audit and Review GMP Validation Reports: Ensure that GMP validation reports, protocols, and reports are internally consistent, accurate, and completely reflect the raw data set and meet current GMP standards and regulations.
- Prepare for Regulatory Audits: Be involved in the preparation for audits by regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA).
- Ensure Data Integrity: Perform data integrity audits/checks for GMP, Good Clinical Practice (GCP), and non-GxP data to ensure data integrity.
Requirements:
- Education: Degree/HNC in a science discipline or at least 4 years of working experience within a Quality Assurance role in a GMP regulated company, preferably in the pharmaceutical or ATMP industry.
- Knowledge and Experience: Knowledge of applicable GMP regulatory requirements and understanding of Pharmaceutical Quality Systems (PQS) requirements.
- Skills and Abilities: Excellent attention to detail, ability to work effectively within a small team, and ability to learn and share knowledge with all departments.
About Us:
CDM Recruitment Ltd - Life Sciences is a leading recruitment agency specializing in the life sciences industry. We are committed to providing high-quality recruitment services to our clients and candidates.
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