Quality Qualified Person in Runcorn

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

Leave: 25 days annual leave (pro rata) plus Bank Holidays

Standard business hours

Purpose of Role: 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.

Key Results Areas:

• 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.

Areas of Impact Affecting the Job: 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.

Planning, Organising and Controlling: 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.

Contact with Others:

• 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.

Decision Making Authority:

• 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.

Knowledge, Skills and Abilities — Skills:

• 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.

Qualifications and Accreditations:

• 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.

Competencies:

• 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 in challenging situations and recovers quickly from setbacks.
• Effective Communication ('Getting it Done Together') - Communicates clearly to others and ensures understanding. Adjusts style of communication appropriately to the audience.
• Leading Others (supervisor only) ('Leading the Way') - The ability to empower, grow, develop and inspire high performing teams and individuals.
• Change & Adaptability ('Creativity Where it Matters') - The ability to recognize and act upon change as a necessity to achieve goals.
• Analytical Thinking & Problem Solving ('Creativity Where it Matters') - Analyses information effectively; identifies the causes of problems and provides realistic and practical solutions to address them.
• Customer Focus ('Caring') - Identifies and understands the customer's needs. Focuses on meeting their needs, ensuring both satisfaction and a continuing business relationship.
• Integrity ('Making Our Families Proud') - Maintains high standards of honesty and trustworthiness. Considers ethical implications of issues and decisions.

Application: If you feel that you have what we need, then please do call Sophie on (phone number removed), or email your up to date CV to: (url removed).

Kinetic plc is a Recruitment Consultancy with over 40 years of experience of delivering staffing solutions to the engineering, manufacturing and technical industries. Kinetic Plc treats all applications with a high degree of care, we review all submissions and will attempt to contact applicants who match the job profile. Those that do not meet the specification may not be contacted but their CV retained to be considered against future opportunities.