QC manager

Role Description

The Client

My Client is a major Pharmaceutical manufacturer based in Co Down Northern Ireland. We are currently recruiting a QC manager to head up the quality team and report directly to the director of Quality

The Role

Reporting to the Director of Quality Control, the post holder will lead and manage the strategic and operational performance of the Quality Control (QC) department, ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to GMP/regulatory compliance and achieving commercial success, whilst ensuring the efficient and effective day to day running of the QC department.

Responsibilities:

  • Responsible for oversight of all aspects of QC department in relation to analysis of material.
  • Develop and implement the QC department’s strategy, to ensure it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals.
  • Implement all QA systems to ensure compliance with GMP.  Ensure that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies.
  • Review of deviations, CAPAs, change controls and documents.
  • Involvement in Quality Investigations due to product non-conformances, deviations and involvement in the necessary CAPAs.  Ensure appropriate investigation of discrepancies, errors, complaints, failures or adverse events requiring documented review and action (if necessary, interrupting processes causing material to be quarantined or placed on hold until matters are resolved).
  • Participate in regulatory inspections and customer audits.
  • Maintain and improve departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service (KPIs), lead time and cost.
  • Responsible for the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially.
  • Participate in self-inspection programme in place.
  • Participate in technical transfer and validation activities, including strategies and approval of protocols and reports.
  • Ensure the availability of adequate competent resources to carry out work in accordance with in house and GMP requirements.
  • Manage, motivate, train, coach and mentor direct reports, to higher levels of management capability.
  • Foster good relations and communications with all members of the team and respond in a timely fashion to internal and external customers.

The Person

  • Scientific degree
  • Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
  • Minimum 10 years’ experience in a Senior Quality role
  • Must have excellent analytical knowledge and technical expertise in all aspects of QC. Expertise and experience in analytical development, validation, technology transfer and troubleshooting.
  • Candidate should have experience with regulatory authorities such as MHRA, FDA, EMA and also experience of hosting audits.
  • Strong interpersonal and communication skill set to effectively work with internal and external stakeholders
  • Strong leadership/team management skills and experience.

 

To discuss this, or other life Science roles, please contact Seamus on 02890725625

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