Quality Qualified Person

Kinetic Recruitment are currently recruiting a Quality Qualified Person to join an international Pharmaceutical company, based within the Runcorn area.

• Annual Salary: £70,000-£85,000 (dependant on experience)
• Duration: 12 Months from start, possibility extended
• 25 days annual leave (pro rata) plus Bank Holidays
• Standard business hours

To perform final QP Batch Certification to ensure that all products released to market comply with the requirements of the Manufacturer's Licence, Marketing Authorisations, ANDAs, Technical Agreements, CE certification, in accordance with EU, USA, or other requirements e.g. Russia, Brazil, Canada.

• To ensure the principles and guidelines of cGMP have been met during manufacturing, packaging and testing operations.
• To verify all batch related documentation is compliant with the requirements of the regulatory authorities.
• To review and certify batches in line with business shipment schedules.
• To ensure Product Licences (Marketing Authorisations), ANDAs, Manufacturer's Licence, Technical Agreements, CE Certification requirements have been met to ensure compliance.
• To ensure planned changes or deviations are supported by appropriate sampling, inspection, testing and check to ensure compliance with the requirements of the regulatory authorities.
• To ensure planned changes or deviations in manufacturing or quality control have been notified in accordance with well-defined reporting system.
• To ensure that manufacturing and testing processes have been validated and all the necessary checks and tests have been performed.
• To ensure appropriate audits, self-inspections and spot checks are carried out by experienced staff.

The release to market of product that does not comply with requirements could result in patient risk, recall of product, detailed investigations and possible prosecution of the QP and Company. Appropriate measures should be taken to ensure the process, testing and product are compliant with all licensed requirements.

Release batches as per business schedule, where possible. Meet the requirement of the Key Result Areas, including ensuring that principle manufacturing and testing processes have been validated, that all necessary checks and tests have been performed and that any planned or unplanned changes in manufacturing or quality control have been notified before any product is released.

Internal:
Departmental/Functional Managers/Supervisors/any other employees as necessary, formally and informally, to progress operations, projects, resolution of issues and future planning requirements.

External:
Suppliers, customers, auditors.

• Disposition for release on all batches of product
• Day to day needs in line with Company policies and procedures
• Functional objectives/actions in line with Business direction agreed with Head of Quality
• Business Quality strategy, objectives/tactics as part of the Site Quality Management Team
• Regulatory compliance in line with Quality and Regulatory management

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• Good communicator and team worker with the ability to set and deliver high performance standards relating to quality, safety, cost and customer service competencies
• Communication
• Influencing

• Qualified to Degree level or equivalent in Science.
• Membership of appropriate professional body.
• Registration as a Qualified Person, with acceptability to the Licensing Authority.
• Significant experience in a senior Quality role with experience as a Quality Leader in a modern manufacturing environment within the pharmaceutical industry desirable.

• Collaboration ('Getting it Done Together') - The ability to work effectively with peers, partners and others, to positively impact performance
• Planning & Organizing ('Getting it Done Together') - Adopts a structured approach, establishes plans, priorities and goals that are clear and logical;
  Organizes resources.
• Drive & Resilience ('Getting it Done Together') - Demonstrates drive and persistence to meet and exceed objectives; remains positive…