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QC Manager

Job Description

£40,000+, No Weekends or Bank Holidays

25 days holiday (excluding Bank Holidays)

Monday - Friday 8:00 am- 4:30pm

Park Royal, NW10 6PN

Crescent Pharma are looking for a QC Manager to join our team here in the 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: The QC Manager is responsible for the day to day management of the Quality Control laboratory and Quality Control staff. The QC Manager will ensure that QC procedures and Test Methods are conducted in compliance with GMP standards, thereby providing continuous support to our product quality. The QC Manager will lead a team of QC analysts, performing testing with effective use of resources. He/she will delegate the tasks to appropriate team members to provide the maximum output with tight deadlines. The QC Manager will ensure that procedures and systems are in place to guarantee Data integrity in the laboratory environment.

Key Activities/Decision Areas

1. Quality Control

· Supervise and coordinate activities of QC Supervisors and their analysts in inspecting starting materials and finished products to ensure conformance with material specifications.

· Responsible for analytical method validation / re-validation and transfers.

· Responsible for on-going R&D work including method development, stability testing.

· Review and check lab work for accuracy and compliance with GMP, procedures and specifications.

· Ensure that analytical results are checked, approved, recorded and available for inspection.

· Ensure that the stability program is followed and testing is carried out effectively.

· Prepare protocols and reports for quality control projects as required.

· Responsible for the management and maintenance of laboratory instruments including calibration and validation.

· Responsible for the accurate collation of analytical data and providing interpretation of trends in order to highlight concerns to product quality.

· Maintain the specifications update program to ensure that updates are performed in a timely manner.

· Ensure all team members are appropriately trained before carrying out activities.

· Oversee the safety, health and environmental aspects of the department ensuring that the staff operate within company policies and practices.

· Take a leading role in the implementation of laboratory developments including the introduction of Laboratory information systems.

2. Periodic Quality Review/Annual Product Review

· Schedule and generate product quality reviews / annual product reviews on time.

· Ensure training records are maintained and updated on a regular basis.

3. Standard Operating Procedures (SOPs) & Batch Documentation

· Provide quality review on a range of quality documentation including SOP, specifications, Quality Methods, GMP records, batch documentation, analytical data packs, workbooks and stability tables.

4. Change Control & Deviation Management & Customer complaints

· Initiate and inform senior of Process Deviations/ Out of Specifications/ need for Corrective and Preventative Actions for quality impact.

· Provide input and complete lab investigations/ deviations/ change control/ CAPA, as appropriate. Play a key role during investigations into incidents that have resulted in non-conformance or compliance failures.

· Investigate customer complaints regarding quality.

· Play a key role during investigations into incidents that have resulted in non-conformance or compliance failures.

· Investigate customer complaints regarding quality.

5. Data Integrity

· Responsible for compliant automated systems and paper systems in the laboratory.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

Benefits:

• Additional leave
• On-site parking

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• Quality control: 10 years (required)

Work Location: In person

Reference ID: CRESPHAR

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