Manx Healthcare has an exiciting opportunity for a GMP Qualified Person to join the team based in Warwick The successful candidate will join us on either a full time or part time permanent basis and will receive a competitive salary based on skills and experience.
A family based pharmaceutical company is seeking an experienced, commercially focused, GMP Qualified Person to work within an established team to help maximise the potential of a well established portfolio of OTC, branded pharmaceuticals and generic medicines. The individual will need to work with and advise development partners to minimise lead times from conception to submissions and through to grant of marketing authorisations for a diverse range of product developments. The individual will play a critical role in both the commercial and quality activities of the company.
The main responsibilities of the GMP Qualified Person role are:
- Responsible for Assisting with QA/RA and other Departments for ensuring that an effective Pharmaceutical Quality Management System is operated and that regulatory obligations as a Manufacturing Authorisation holder are fulfilled.
- Collaborate with all appropriate stakeholders in order to achieve and maintain the required quality and compliance standards in GMP areas.
- Ensure compliance with the conditions of the Marketing Authorisation by interacting with the Regulatory.
- Demonstrate expertise regarding Quality Assurance (QA), Good Manufacturing Practices (GMP) including Good Distribution Practice (GDP) and Quality Control (QC) in interactions with clients, authorities, and internal departments.
- Provide support internal and external GMP/GDP Audits in coordination with Quality Assurance.
- Provide input related to Manufacturing Authorisation updates.
- To be present during Regulatory Inspections and involvement in communications with the Inspectors.
- Apply high ethical standards and professional conduct with clients and with the Authorities, act as a Qualified Person in accordance with Annexe 16 of the EU GMP to provide final both certification/release, participate/perform and/or ensure audits of third party providers in order to ensure compliance with EU GMP standards have been achieved in coordination with Quality Assurance. To review and release batches to market in a timely manner so as not to cause stock outs.
- Provide QP Declarations in support of importation activities and will be expected to maintain up to date awareness of regulatory requirements and participate in continuous improvement projects.
- Knowledge of process improvement techniques and dealing with Corrective Actions and Preventative Actions (CAPA), promoting compliance and adherence to Quality Polices, SOPs and develop & deliver training programs, auditing, approve changes/deviations and OOS as per approved SOPs and take an active role in the control & implementation processes when required.
- Ensure GMP compliance across the Organisation is being achieved with QA and R&D Departments, offering advice and guidance with respect to regulatory expectations and recognised best practice.
- Provide guidance and approval of PQRs/SOPs and other relevant GMP documents for continuous improvement.
- Continue to develop as a current QP professional by keeping up to date on new regulations, CPD and other trainings.
- Give support to any other activities in the Quality related areas as requested by the company from time to time.
The role could be considered on a full time or part time basis for a minimum of 3 days per week. In order to carry out the role effectively and to be able to integrate with the current Quality, Regulatory and Commercial team the successful GMP Qualified Person must be willing to be based in our office in Warwick.
If you have the skills and knowledge to become our GMP Qualified Person then please click ‘Apply’ now.
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