Quality Assurance Assistant

2 days ago

Hemel Hempstead, United Kingdom Novumgen Limited Full time

**Activities and responsibilities**:

- Review paper and electronic batch records for completeness, clarity and GMP/GDP compliance.
- Review raw material related documentation and release raw materials.
- Provide quality support for the development of appropriate Corrective and Preventative Actions (CAPA’s).
- Manage and maintain QMS.
- Provide advice to requesting departments regarding GMP/GDP compliance
- Review and approve QA controlled documentation (SOP’s, batch records, working instructions).
- Plan, execute, and oversee inspection and testing of incoming and outgoing product to confirm quality conformance to specifications and quality deliverables.
- Develop and update company complaint procedures to ensure capture, investigation, and documentation of complaints.
- Monitor risk-management procedures.
- Maintain and analyse problem logs to identify and report recurring issues.
- Document quality assurance activities with internal reporting and audits.
- Develop new standards for production and design, with continuous improvements as identified and create testing protocols for implementation across all service lines.
- Assess change requests for consistency, relevance, GMP/GDP compliance and clarity.
- Review and prepare batch release documentation.
- Support continuous improvement activities.
- Prepare for/support audits by corporate and MHRA representatives.
- SOP administration, update, review, training and implementation.

**Your background and profile**:

- BSc or MSc in pharmacy or equivalent.
- Experience working in the pharmaceutical industry preferred.
- Knowledge of current GMP/GDP regulations.
- Good communication skills in English.
- Critical and highly accurate.
- Knowledge of quality assurance terminology, methods, and tools.
- Analytical, problem-solving, and decision-making skills.
- Able to work independently as well as working well within a team.

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