QA Executive

2 weeks ago

London, United Kingdom Crescent Pharma Full time

**Role Purpose**
- To support Quality Manager and QPs in maintaining the Quality system at Crescent Manufacturing. Review and compilation of batch-related documentation and carry out In/process testing within production.

**Key Accountabilities**
- 1. Duty and responsibilities_
- Review of the batch manufacturing/testing/packaging documentation for compliance with approved procedures and the product licence, for submission to the Marketing Authorisation Holder (MAH).
- Management of the archiving of Quality Management documentation, product samples and batch release paperwork to ensure compliance with company policies and procedures as well as regulatory guidelines.
- Assisting with investigations, where necessary, and supporting the resolution of issues.
- Ensuring that all changes are entered into appropriate quality systems to ensure the change is consistently implemented to the required standards, with all relevant and supporting activities undertaken.
- Providing support for the initiation of any regulatory changes by providing relevant and appropriate data packages and reports.
- Writing and review of Deviation Reports and CAPAs associated with Crescent Pharma products and reporting to MAH.
- Participation in the internal audit programme.
- Participation in external audits of Crescent Manufacturing suppliers (as appropriate) and providing support for any assessment activities.
- Participation in regulatory audits at Crescent Manufacturing (as appropriate) and providing support for assessment activities.
- Providing support in maintaining the Crescent Manufacturing Documentation System to ensure that all critical procedures are documented and are in compliance with company policy and regulatory requirements.
- Preparation of Product Quality Review reports.
- The writing and amendment of Standard Operating Procedures that cover GxP activities.
- Carry out customer complaints investigations and report back to MAH.
- The creation, review and approval of process/analytical/equipment/system validation protocols and reports.
- Recording and meeting Quality department Key Performance Indicators (KPIs).
- Providing support in project based activities.
- Providing training as requested, and in line with current internal policies regarding training, to support ongoing GxP requirements and understanding.
- Carry out testing of incoming packaging materials
- Carry out periodic in/process testing within the production department
- Carry out sampling of raw materials
- Carry out environmental monitoring
- 2. Planning, organising and controlling_
- Planning and organising own allocated workload to ensure that projects are completed within the timeframe agreed with management and, to ensure that individual and departmental objectives are met.
- 3. Contact with others_
- Internal_
- QA
- Supply Chain / Planning
- Customer Services
- Warehouse
- External_
- Third Party Sub-contractors (EU and Non-EU)
- QP Consultants
- Marketing Authorisation Holder
- 4. Major challenge of the job_
- To assist in the maintenance of existing quality standards in line with company policies and regulatory guidelines, to ensure the quality of Crescent Manufacturing products.
- 5. Knowledge, skills and experience required:_
- Educated to degree Level standard, or equivalent. A degree in Chemistry, Pharmacy, Biochemistry, Microbiology or Biology would be desirable.
- Effective time management skills with a flexible approach and the ability to adapt quickly to changing priorities.
- Self-motivated and organised with ability to work using own initiative and as a team.
- Good attention to detail and ability to follow defined procedures and regulatory guidelines.
- Excellent interpersonal and communication skills.
- Good IT skills (Excel, PowerPoint, Outlook, Word).
- 6. Decision making authority:_
- Responsible for planning and prioritising personal workload and raising with the QA Team any anomalies identified.
- Follow-up with contracted service providers with guidance from the QA team.

**Job Types**: Full-time, Permanent

**Salary**: £27,000.00-£32,000.00 per year

**Benefits**:

- On-site parking

Schedule:

- 8 hour shift

**Experience**:

- Quality Assurance: 4 years (preferred)

Work Location: In person

Reference ID: CRESMANEX

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