QA Supervisor - Barnsley, United Kingdom - Crescent Pharma
Description
£30,000+, No Weekends or Bank Holidays25 days holiday (excluding Bank Holidays)
Monday - Friday 8:00 am
- 4:30pm
Job Role:
To support the other QA Supervisors, Quality Managers and QPs in the generation and revision of Quality documentation, as well as the review and compilation of batch-related documentation, generated both internally and externally.
Principal Responsibilities:
- Review of the batch manufacturing/testing/packaging documentation for compliance with approved procedures and the product licence, for submission to the Qualified Person for release.
- Liaising with contract laboratories to ensure the timely analysis of products in preparation for EU QP certification.
- 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.
- Liaising with suppliers regarding quality or batch related issues, assisting with investigations, where necessary, and supporting the resolution of issues.
- Ensuring that all changes are entered into appropriate quality systems
- 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 or contact activities carried out using Crescent Pharma product licences.
- Review of master processing documents against licence details and Technical Agreements prior to use.
- Participation in the internal audit programme.
- Participation in external audits of Crescent suppliers
- Participation in regulatory audits at Crescent
- Providing support in maintaining the Crescent Documentation System
- Requesting, executing and reviewing Product Quality Review reports.
- The writing and amendment of Standard Operating Procedures that cover GxP activities.
- The review and processing of, and responses to customer complaints.
- The creation, review and approval of process/analytical/equipment/system validation protocols and reports.
- 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.
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.
- Selfmotivated 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).
Job Types:
Full-time, Permanent
Salary:
£30,000.00-£40,000.00 per year
Benefits:
- Additional leave
- Onsite parking
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Experience:
Quality Assurance: 6 years (preferred)
Work Location:
In person
Reference ID:
CRESPHAR
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