Sector: Life Sciences
Consultant: Harvey Havell
Salary: £60000 - £75000
Job Status: Permanent / Full Time
My client, a large pharma company, is in need of 2 QPs for their sites in Luton and Hartlepool. Ideally on a PERMANENT basis but will consider contractors as well. This is a perfect opportunity for a QP looking for their next challenge. Competitive salary and immediate start available.
- 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 Authorization holder are fulfilled.
- Collaborate with the Head of Production and the Head of Quality Control In order to achieve and maintain the required quality and compliance standards in GMP areas.
- Ensure compliance with the conditions of the Marketing Authorization by interacting with the Regulatory Department.
- 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 QA with GMP/GDP consultancy and training, support internal and external GMP/GDP Audits in coordination with Quality Assurance.
- Provide regulatory input related to Manufacturing Authorization updates.
- Ensure availability of QA Agreements with suppliers and subcontractors with Quality Assurance Department, 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 Annexure 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.
- 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 Organization is being achieved with QA and R&D Departments, offering advice and guidance with respect to regulatory expectations and recognized best practice
- Support Line QA staff in their inspection and checking duties as required, providing training to staff to increase understanding of the regulatory GMP requirements and implementation of best practices.
- 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.
- Oversight the compliance with the GMP and with the internal procedures of the activities within the Quality Control Department like the Chemical and Microbiological Laboratories to ensure a smooth and effective functioning of these Departments.
- Give support to any other activities in the Quality related areas as requested by the company from time to time.
You will be working alongside the fastest growing recruitment company in the UK, who provide an unrivalled service to all of their clients and candidates across the United Kingdom. Seven currently offer the best contractor pay rates in the UK for Life Sciences, making us the best option for maximising your earning potential and career fulfilment. Seven Consultants are passionate about placing you in the best possible role, for the best possible rate, while providing a support platform, which is accessible around the clock.
Are you ready for the challenge? If so, we look forward to hearing from you.
What else can you expect from Seven?
– Specialist Consultant allocated to you with all the expertise you require.
– Excellent Payroll and Compliance System, ensuring that you are paid on time, every time.
– Access to Exclusive Rates, allowing you to gain earnings that no other agency can offer you.
– £250 Referral Bonus for every person you successfully refer to Seven.
If you are interested in this opportunity, please call 020 3887 7365. Please ask for Harvey Havell in the Life Sciences team.