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Head of Quality - Manufacturing Facility, Midlands
Team Horizon is seeking a Head of Quality for our client's manufacturing facility in the Midlands. In this role, you will oversee the Quality Assurance and Quality Control Teams, support the implementation, maintenance, and continual improvement of the company QMS, and undertake the role of QP named on the relevant MIA(s).
Why you should apply:
* Opportunity to work with a diversified portfolio of products across multiple therapeutic areas, with strengths in analgesics and anti-infectives.
* Excellent chance to utilise QP eligibility and leadership experience in a Head of QA role overseeing Quality Assurance and Quality Control teams.
* Highly competitive salary and benefits on offer.
What you will be doing:
* Ensure an appropriate, compliant QMS is in place to ensure site compliance, including regulator inspections and product throughput.
* Perform QP certification of products for market release, as necessary, in accordance with the release schedule.
* Manage site quality operations and batch certification, ensuring all activities are coordinated for compliance and timely batch release.
* Review or delegate review of batch documentation related to manufacture and testing, confirming certification in the QP register, and ensuring GMP compliance.
* Communicate any issues impacting release to management and supply chain.
* Promote GMP, GDP, and Quality Management Systems within the site, seeking improvements where necessary.
* Support investigations related to quality non-conformances, complaints, recalls, and batch investigations.
* Review and approve QMS documentation related to quality activities.
* Establish and monitor KPIs for all quality activities and coordinate the site Change Review Board.
* Manage complaints and recalls to closure.
* Ensure timely internal and external audits, and support preparation for regulatory, company, and customer audits.
* Oversee training programs and ensure completion of site training on QMS processes and SOPs.
* Implement management review processes through group quality review meetings.
* Maintain accurate records of authorized activities and stay updated on legislation and industry practices.
* Complete additional tasks as assigned.
What you need to apply:
* Eligibility to be named on a manufacturer's license as Qualified Person under EU Directive 83/EC.
* Minimum 5 years of quality management experience in the pharmaceutical industry.
* Well-organized with effective communication skills, reliability, IT literacy, and project management abilities.
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