£40,000+, No Weekends or Bank Holidays
25 days holiday (excluding Bank Holidays)
Monday – Friday
Crescent Pharma are looking for a Quality Manager to join our team here in Basingstoke, UK.
The selected candidate will be required to work within a small team to execute the management teams plan to maintain regulatory approval and improve the current infrastructure/procedures in line with GMP guidelines. The ideal candidate will take a hands-on approach in their work, be experienced working with growing teams and have experience working in a GMP environment. Start date would be immediate and the role will be permanent.
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.
* 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.
* 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).
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: Full-time, Permanent
Salary: £40,000.00-£60,000.00 per year
* Additional leave
* On-site parking
* Day shift
* Monday to Friday
* Quality Assurance: 7 years (preferred)
£40000 – £60000/annum