QA Executive London, England
Job description
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.
CV’s provided in response to this advert will be forwarded to appropriate staff members within Crescent Group for shortlisting for this job application. Your cv may be retained on our system until the vacancy is filled. If you attend an interview, any comments or test results will be retained as part of your personnel record, along with your cv, if you subsequently take up a position. If you are not offered a position these will be deleted 6 months after the campaign is concluded in line with our retention policy.
You have the right to access, rectify, restrict processing and in some cases erasure or data portability. Should you wish to exercise these rights please contact us via our website, contact us page with “Personal data” in the subject line.
Job Types: Permanent, Full-time
Salary: £26,000.00-£31,000.00 per year
Benefits:
- On-site parking
Schedule:
- 8 hour shift
Experience:
- Quality Assurance: 4 years (preferred)
Work Location: In person
Reference ID: CRESMANEX
