Technical Manager/Responsible person
Attractive salary & package
The Technical Manager manages all aspects of the company's QMS. To act as the company's Responsible Person for licenced medicine and medical devices. They proactively support and work closely with the Managing Director, laboratory and Quality Manager to ensure that both the company and products meets the standards required for continued regulatory compliance. Whilst observing and adhering to ISO 13485/GMP standards.
- This includes the responsibility, assisted by the QA Manager, for ensuring our Quality Assurance function meets the requirements of the company, notified bodies, the MHRA and other regulatory bodies as appropriate.
- To act as the company's Responsible Person for licenced medicine and medical devices.
- The individual operates as our lead contact with our external contracted QP and QPPV.
- The role oversees the laboratory function including the evaluation of scientific and analytical data from QC testing and batch manufacturing.
- Produce and review the technical and regulatory documentation in accordance with GMP, ISO 13485 and regulatory requirements in line with continuous improvement programmes, deal with investigations and support Risk Management activities.
- Support audits and inspections and be lead contact with our QP and QPPV.
- Conduct training, where necessary, of company personnel regarding new regulations and policies that could impact the company's products or processes and refresher training to meet existing guidelines.
- Other duties as necessary to support the operations of the Laboratory, Quality and Regulatory Department.
- Bachelor degree or equivalent in Chemistry and will have worked previously in a Laboratory, Quality or Regulatory Affairs role ideally within the Licensed Medicine and Medical Device Industry.
- Experienced in quality management systems (QMS) and procedures.
- Previous experience acting as an RP would be advantageous.
- Leadership experience - ability to train, coach and manage teams.
- Experience in dealing directly with Notified Bodies, Competent Authorities desirable. Having worked to ISO 13485/GMP.
- Demonstrate excellent communication skills.
- Demonstrate strong organisational skills, including the ability to prioritise workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial.
If you would like to apply please use the link provided. For more details regarding this position please call Bal on 0121 728 8455.
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