Quality Assurance Manager

Job Description:

We are a Global Recruitment specialist that provides support to the clients across EMEA, APAC, US and Canada. We have an excellent job opportunity for you.

Job Title: Quality Assurance Manager II
Location: Camberley
Duration: Until end of Dec. 2025
Pay-rate: £517.46 per day Inside IR35

Role Purpose:
Assurance that the product quality conforms with specifications and that production activity is compliant with client quality policy and GxP requirements. Ensure that relevant documentation is up-to-date and archived correctly. Ensure state of the art GxP know-how and future trends in the field of GxP.

Major Accountabilities:
Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical/pharmaceutical products are in compliance with the client Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
Prepare, review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and monitor self-Inspection schemes for all sections. Monitor actions and corrections accordingly.
Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions. Archive relative documentations and manage/Approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the client Quality Manual. Ensure investigations are correctly executed. Ensure all required actions are taken appropriately and in a timely fashion.
Escalate any issues or instances of instability per the client escalation policy, and initiate any market action that is required. Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing accordingly as well as ensure that Change requests, are managed according to the client SOPs from receipt, through to the implementation and closure.
Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and Pharmaceutical authorities in respect to up-dated GxP ovide latest know how in the field of GxP and other quality related fields. Identify repetitive activities and regulatory areas for which SOPs are required. Initiate the introduction of SOPs.
Plan, initiate and monitor basic GxP-training for all employees in regular intervals. Be responsible for annually training program and implementation.
Establish and maintain cross-functional contacts with peer organization and authorities and follow-up quality related developments in the field of Pharmaceutical products
Support launches of product in close collaboration with BD& L partner and/or development organization.
Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations.
Ensure that coordinated contact is maintained with all parties (the Regulatory Authorities, the local partners and stakeholders and Global QA.)

Key Performance Indicators:
Local GMP/GDP Quality System in place and continuously updated, as required
GMP/GDP risks proactively identified and effectively mitigated

Experience:
Operations Management and Execution
Participating in volunteer/community projects
Functional Breadth
Collaborating across boundaries

Competencies:
Operational Excellence
Project Excellence
Being Resilient

Skills & Knowledge:
Quality Assurance
Quality Management
Regulations & Guidelines
Product Release
Regulations & Guidelines
Quality Change Control
Risk Management

Language:
English

If you are interested in this position and would like to learn more, please send through your CV and we will get in touch with you as soon as possible.
Please note, candidates are often Shortlisted within 48 hours.