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Quality Assurance Director

Talentspa
Job LocationLoughborough
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

This is your chance to work for an award winning top 100 company in the Leicestershire area. You could be helping millions of people worldwide to gain access to quality and affordable healthcare.We are looking to recruit an experienced and knowledgeable Quality Assurance Director to join our existing QA Team. The Quality Assurance Director reports to the Chief Operating Officer (COO) and will work closely with the Senior Management Team (SMT) to direct and implement strategies across the business to ensure compliance with Pharma regulations.About the Quality Assurance Director Role:The Quality Assurance Director is responsible for overseeing the Qualified Persons and Operational QA activities to ensure timely and compliant product release /batch release in accordance with current Good Manufacturing Practice (cGMP) and Good Distribution Practice (cGDP).In addition to the batch release process, this role is responsible for ensuring a compliant Quality Management Systems (QMS) is in place and overall site compliance.The Director is responsible for managing all QA functions, and working with cross-departmental leadership to deliver high quality products on schedule and promote a quality mind-set across the entire company.Quality Assurance Director Responsibilities:

  • Manage a team of Qualified Persons responsible for supporting the GMP-compliant batch certification and release process.
  • Ensure the performance of regular Product Quality Reviews is carried out by the QA and QP groups.
  • Oversee and manage the Operational Quality Assurance team who support the Contract Manufacturing and Contract Laboratory activities.
  • Facilitate innovation and continual improvement of the product throughout its lifecycle.
  • Ensure the effective management and continuous improvement of the Quality Management System (QMS) including completing management reviews, CAPAs, Change Controls, Deviations, internal/external auditing and project management.
  • Represent QA in high-level Product launch and commercialisation meetings.
  • Be the Quality authority and point of contact for local and international health authorities
  • Ensuring all appropriate calibration maintenance and validations are conducted.
  • Author and review internal company reports and regulatory documentation, as required.
  • Lead audits and represent the company as required.
  • Advise the Senior Management Team on relevant quality issues and resource needs.
    • Quality Assurance Director Requirements:
  • The ideal candidate must be able to demonstrate excellent industry experience from a regulated, pharmaceutical background
  • Proven history within Quality Assurance at a senior leadership level.
  • It is essential that candidates are technical experts in the virtual release process i.e. experience working with Contract Manufacturing Organisations (CMO)
  • Extensive generic pharmaceutical industry knowledge and experience.
  • Qualified Person status would be beneficial but it is not essential.
    • Why MorningsideWe also offer a number of company benefits including:
  • Competitive salary and package
  • Monday - Friday: 9.00am-5.00pm
  • Excellent Pension Scheme
  • Private Healthcare – medical insurance and cash back schemes
  • Excellent opportunities for growth and progression
  • Free parking
    • About Us:Morningside Pharmaceuticals Ltd is a leading manufacturer, wholesaler and exporter of branded generic medicines and healthcare products worldwide. We are proud to be a key manufacturer of medicines, supplying to the NHS, retail pharmacy sector and international markets, as well as being the UK’s trusted supplier to Aid agencies and NGOs.If you think that you are suitable for this Quality Assurance Director role, please apply now!

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