Location West Yorkshire, Yorkshire
A fantastic opportunity to join a Global Pharmaceutical Manufacturing Organisation as a Quality Assurance Manager, delivering the highest quality products in an innovative and renowned industry.
- Manage the formal planning and control of the day to day activities of the quality assurance department in order to meet product release dates
- Work with the regulatory function to provide input on product registration needs i.e. NDA information, DMF filing, supplements and annual review reports
- Implementation of and adherence to business quality systems
- Provide expertise and support on quality and cGMP compliance work processes to the plant partners
- Provide batch release, incident investigation, planned deviations and management of change QA review
- Maintain product, raw and packaging material specifications
- Lead / participate in customer and agency audits and provide inputs to other departments in order to initiate changes based on audit responses
- Work with customers to coordinate, document and communicate complaint and problem relation activities
- Conduct internal audits
- Review & approve all quality related documentation & reports
- Ensuring that effective systems are used to approve or reject raw materials, packaging materials and labels
- To actively participate in safety initiatives and ensure safety and other statutory compliance
- Identifying the resource requirements of the department, coordinating approvals and ensuring the required resources are available
- Performance review and evaluation of team members to facilitate the competency development
To succeed in this challenging, people focused business, you will:
- Must be educated to graduate or HNC/HND level in chemistry or a quality related subject
- Strong experience of Quality Assurance in a pharmaceutical manufacturing environment, working to appropriate standards of cGMP is essential
- Working knowledge of FDA and MHRA regulatory requirements and ICH Q7 and ISO 9001 is essential
- Must have experience of managing and successfully leading a team
- Excellent communication skills both written and verbal
- Ability to contribute to effective team output by cooperation, participation and commitment to shared goals
- Ability to build relationships with other functions.
- Meticulous attention to detail
- Ability to interpret and critically assess data
- Ability to challenge and influence others
- Problem solving skills & ability to work under pressure
- A large, Global Pharmaceutical Manufacturing Organisation with a track record of delivering the highest quality products to a prestigious client base
- Focused on achieving growth alongside an efficient and productive manufacturing environment
- They are well positioned to invest in continuous improvement, technological innovation and customer service.
Interviews are to be held shortly, and suitable candidates will be contacted within 24 hours of application.
To apply for the role, please send your CV and salary details to Expion Search & Selection using the ‘Apply Now’ button. If you would like to have a confidential discussion on the role, you can contact the Consultant, Hannah Haider.
Expion: Our Quality & Technical recruitment brand is well respected for the high quality of work we have delivered for both clients and candidates. Our in-depth knowledge of recruitment across core sectors enables us to provide advice based on experience and to give you the best access to client vacancies.