HEAD OF QUALITY ASSURANCE
Key role information
  • Date added: 31-12-24
  • Hours: Full time hours – Monday to Friday, flexible on hours (Must be in work on core hours 10am to 4pm)
  • Wage: up tp £80 000 p/a DOE
  • Sector: Commercial
  • Location: Mirfield
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An exciting opportunity...

HEAD OF QUALITY ASSURANCE

Juice Personnel Ltd are currently recruiting for a Quality Assurance Manager on behalf of our client, a global integrated pharmaceutical company. Our client is dedicated to accelerating access to affordable and innovative medicines across various therapeutic areas.
This position exists to provide Quality Assurance leadership at the Mirfield site according to quality norms, cGMP requirements, and FDA/MHRA compliance needs

You will be responsible for leading the quality assurance department’s daily activities to ensure product release dates are met, managing resources, and ensuring all activities align with cGMP standards. This role involves working cross-functionally with teams across the business to support quality and compliance initiatives and providing leadership to a small team.

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The Role

  • Management of Daily Activities: Oversee the planning and control of daily quality assurance activities to meet product release schedules.
  • Resource Management: Identify and coordinate departmental resource requirements, ensuring approvals and availability.
  • Team Performance and Development: Conduct performance reviews, ensuring competency development and that QA personnel are appropriately trained.
  • Regulatory Support: Collaborate with the regulatory function on product registration needs such as NDA information, DMF filing, supplements, and annual review reports.
  • Quality System Implementation: Ensure adherence to business quality systems.
  • Compliance Support: Provide expertise on quality and cGMP compliance to plant partners.
  • Batch Release and Incident Investigation: Oversee batch release, incident investigations, deviations, and change management.
  • Material Specifications: Maintain product, raw material, and packaging specifications.
  • Customer and Agency Audits: Lead or participate in audits, responding to findings and initiating changes.
  • Complaint and Problem Management: Coordinate and document customer complaints and related activities.
  • Internal Audits: Conduct internal audits and review/approve validation protocols, SOPs, and reports.
  • Investigations and Approvals: Investigate "out of trend" and "out of specification" results, approving raw materials, packaging materials, labels, and APIs.
  • Safety and Compliance: Actively participate in safety initiatives, ensuring statutory and safety compliance.

About You

  • Educated to graduate level in chemistry or a quality-related subject.
  • A background in Quality Assurance is essential.
  • Experience in the manufacture of pharmaceutical APIs and fine chemical intermediates to appropriate cGMP standards is required.
  • A strong working knowledge of FDA and MHRA regulatory requirements, ICH Q7, and ISO 9001 is essential.
  • Experience working cross-functionally and with multidisciplinary teams is necessary.
  • Experience managing a team would be advantageous.
  • Communication Skills: Excellent written and verbal communication skills.
  • Teamwork: Ability to work cooperatively and effectively within teams and with other functions.
  • Self-Motivation: Ability to work independently and under pressure to meet deadlines.
  • Relationship Building: Build and maintain relationships across various functions.
  • Attention to Detail: Meticulous in reviewing and interpreting data.
  • Problem Solving: Strong analytical, problem-solving skills with the ability to challenge and influence others.
  • Leadership: High standards of leadership and management skills.

Benefits

  • Flexible working:
  • 40 hours per week, typical hours are 08.30-17.00 with a 30-minute lunch break, hours are flexible the company core hours are 10.00-16.00
  • Annual leave:
  • 25.5 days plus bank holiday (the 0.5 day is for Christmas Eve)
  • Then an additional day after 5, 10 and 15 years’ service up to 28.5 days
  • 8 days can be carried over or cashed in
  • Enhanced Maternity, Paternity and Adoption leave:
  • Over a years’ service get enhanced parental leave
  • Enhanced maternity which is 13 weeks full pay then 26 weeks half pay
  • Enhance paternity is 2 weeks full pay
  • Sick pay:
  • 4 weeks full sick pay every 52 weeks
  • Income Protection
  • Business and Personal Travel Insurance
  • Full personal travel insurance for employee, partner and children
  • Life Assurance 4 x salary
  • Private Medical Insurance (Two-thirds of the premium funded by the Company; remainder by employee)
  • Premium varies dependent on type of cover i.e., single, self & partner, family etc
  • Sports and Health Club Reimbursement
  • Pay 70% of gym or sports clubs up to £1200 per year
  • Cycle to work
  • Annual Health Checks
  • Employee Assistance Programme

Frequently Asked Questions

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