Quality Manager

31 Aug 2017
21 Sep 2017
Contract Type
Full Time
Job title: Quality Manager

Location: Bromsgrove/Droitwich, West Midlands

Salary: Competitive

Working hours: Full time

The Company

An exciting opportunity has arisen in the West Midlands area to work for Kimal on a permanent, full-time basis as a Quality Manager.

The day-to-day duties

Working as a part of our growing team in the West Midlands, the successful Quality Manager based in the Bromsgrove and Droitwich area will be accountable for the implementation, development and continual compliance of the Quality Management System throughout the company, to ensure the best possible products and services are provided to the customer. To provide effective communication on all Quality related issues within the Company. Provide Quality support for new and existing process development and validation within the Company.

Other Duties and Responsibilities (Key Accountabilities)

- Monitor and review all company processes, in conjunction with the department manager/functional head in order to ensure that they continually conform to the relevant regulations and standards and that there is a process of continuous development.
- Carry out the duties and responsibilities as defined in ISO 9001, ISO14001 & ISO 13485.Ensuring that a quality management system is implemented and maintained;
- Focusing on the management of authorised activities and the accuracy and quality of records;
- Ensuring that initial and continuous training programmes are implemented and maintained;
- Coordinating and promptly performing any recall operations for medicinal products;
- Ensuring that relevant customer complaints are dealt with effectively;
- Ensuring that suppliers and customers are approved;
- Approving any subcontracted activities which may impact on GDP;
- Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
- Deciding on the final disposition of returned, rejected, recalled or falsified products;
- Approving any returns to saleable stock;
- Ensuring that any additional requirements imposed on certain products by national law are adhered to
- Ensure effective communication between other team leaders in the provision of quality information and requirements.
- Implement and maintain a corporate Quality Management System across all UK sites.
- Implement and maintain a corporate Environmental Management System across all UK sites
- Ensure compliance with internal procedures as well as external audit requirements.
- Ensure compliance of environmental control for Company manufacturing, packaging and storage facilities
- Provide robust and timely audit activities across the Company, including procedural, process and product audit.
- To liaise with principals, suppliers and contracted manufacturers over all issues of product compliance.
- Ensure a performance management process in line with company policy, is performed throughout the Quality Department.
- Manage the review and approval of qualification/validation protocols and qualification/validation reports
- Represent the company on Quality issues related to Kimal plc. Business
- Act as first point of contact for quality activities across the manufacturing facility.
- Provide a lead in problem solving, failure and root cause analysis including risk assessments and FMEA activities.
- Other duties as necessary to support the operations of the Quality and Regulatory Department.

Knowledge, Skills and Qualifications required:

- Previous experience in Quality role, ideally with ISO 13485, ISO 14001, minimum ISO 9001
- Broad knowledge of quality systems and procedures
- Certificated Auditor
- 21CFR Part 820 experience would be an advantage
- Good Manufacturing Practice (GMP) experience preferred

What the company will offer:

The successful Quality Manager based in Droitwich will receive a competitive salary, a flexible benefit scheme, and 25 days holiday increasing with service.

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