The individual shall be able to bring ISO 13485:2016, GMP and GDP expertise into the company. The role will be responsible for the quality and compliance of the Quality Management System (QMS) and development/commercial activities related to ISO 13485:2016/GMP/GDP. They will report to the Quality Director and support the Responsible Person and Qualified Persons when necessary. Specific responsibilities will include the review and approval of documentation, review and approval of Quality Technical Agreements with CMOs, review and assessment of supplier quality metrics, oversight of ISO 13485:2016/GMP/GDP SOPs ensuring harmonization across. Ensuring the business is driven by continual improvement in quality through robust CAPA processing and change control. In addition, the jobholder will plan, prepare and conduct ISO 13485:2016/GMP/GDP audits of suppliers while maintaining constant audit readiness to successfully host regulatory agency inspections or Notified Body audits.
Duties and Responsibilities
- Review and assessment of supplier quality metrics
- Oversight of ISO 13485:2016/GMP/GDP SOPs, ensuring harmonization
- Maintaining a CAPA system. To have expertise in quality system processes e.g. Risk management/RCA/CAPA; ensure quality systems are both compliant and lean
- Maintaining a change control system.
- Job holder will plan, prepare and conduct ISO13485:2016/GMP/GDP audits of suppliers while maintaining constant audit readiness to successfully host regulatory agency inspections or Notified Body audits.
- To approve specifications, test methods and QC procedures and any other quality driven document as necessary
- To support and manage the QMS
- To support the company in getting a WDA license and hence adaptation of the QMS to align to GDP in addition to ISO 13485:2016
- To liaise with relevant suppliers on all aspects of Product Change and deviations from specification and the validation required before changes can be implemented.
- To support with review and approval of Technical Agreements with CMOs
- To liaise with relevant suppliers on a regular basis
- To liaise with the Qualified Persons for batch release as and when necessary. To liaise with the Responsible Person as and when necessary
- To liaise with QPPV or deputy QPPV regarding Pharmacovigilance and Medical Device Vigilance, as and when required, on any complaints relating to adverse effects and safety information or any FSCA, incidents etc. as applicable.
- Complaints Handling – To investigate in accordance with written procedures all complaints relating to the quality of the products and if substantiated to initiate action to prevent recurrence
- To liaise with regulatory for variations / new manufacturing authorizations or other regulatory submissions.
- To support and coordinate the preparation and hosting of MHRA, Notified Body audits and customer inspections.
- To carry out self-inspections or internal audits.
- To carry out external audits of contractor manufacturers and suppliers
- To support the maintenance of CE technical File
- Chair regular quality meetings using trends and data to review and improve performance
- Organization and preparations of management review meetings
We are seeking a highly experienced ISO13485:2016/GMP/GDP professional capable of establishing
Themselves in this position.
- You will need 5 to 10 years relevant QA experience
- Your expertise will cover all aspects of ISO13485:2016/GMP/GDP documentation, QMS ownership, SOP management, CAPA tracking, and process improvement, auditing and training/mentoring. In addition, you should be used to working with, and having oversight of, external suppliers including CMOs.
- A degree in Life Science or Applied Sciences with relevant experience within both Medical Devices and Pharmaceutical industry
- Auditing experience/qualifications ISO13485:2016, GMP or GDP
- Excellent communication and interpersonal skills, with the ability to interface with broad range of internal and external stakeholders at all levels of the organization.
- Demonstrated ability to operate independently and have appropriate judgement to make or facilitate decisions.
- Ability to travel (currently Europe), up to 25%
- Any background in Analytical Testing of
Pharmaceuticals is an advantage
Want to join a dynamic and innovative team, expert in the field of health?
Do you think you have the qualities and skills expected for this position? So do not wait any longer and send us your application to the following address: Shipra.firstname.lastname@example.org