Job Description
Job description
Crescent Medical are continuously recruiting for a Quality Assurance (QA) executive to join our team at our site in Bolton. The ideal candidate will have experience working in a production based QA team. The role offers a great opportunity for career progression in one of the fastest growing pharma companies in the UK.
JOB PURPOSE:
To support the other QA Executives, Quality Manager 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 ACCOUNTABILITIES:
- 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 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 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 (as appropriate) and providing support for any assessment activities.
- Participation in regulatory audits at Crescent (as appropriate) and providing support for assessment activities.
- Providing support in maintaining the Crescent Documentation System to ensure that all critical procedures are documented and are in compliance with company policy and regulatory requirements.
- 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.
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
.
CONTACT WITH OTHERS:
Internal
QA
Regulatory
Supply Chain / Planning
Customer Services
Warehouse
Sales & Marketing
External
Third Party Sub-contractors (EU and Non-EU)
Regulatory / QP Consultants
Customers
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 Pharma’s products and sub-contractors.
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: £25,000.00-£30,000.00 per year
Benefits:
Schedule:
Experience:
- Quality Assurance: 5 years (preferred)
Work Location: In person
Reference ID: CRESMEDEX