QMS Officer

The QMS Officer will be responsible for the maintenance and development of the Quality Management System (QMS) as applied at the manufacturing site, ensuring the system is robust, is traceable and is kept in good order in compliance with GMP.

 

Key Responsibilities

▪ To oversee the management, implementation and maintenance of the QMS system to include regulatory updates

▪ To manage the filing and distinction of QMS documentation to confirm traceability

▪ To manage timely closure of CAPA, Change Controls, Deviations and Customer Complaints

▪ To conduct support sessions with owners of outstanding QMS documentation to ensure closure of actions with support from QA management

▪ To support the review and approval of all master manufacturing records, and all modifications to the master manufacturing records.

▪ To be involved in problem solving in both QC, QA and production situations when needed

▪ To write Standard Operating Procedures, approve production operating manuals, and maintain updated Standard Operating Procedures.

▪ To review decisions for investigating product complaints, and review and approve the findings and follow-up action of any investigation performed.

▪ To compile Product Quality Reviews as required by GMP.

▪ To assist in the management of change controls and associated actions.

▪ To assist in Quality KPI's to monitor quality performance across the business.

▪ To act as support and cover for the QA QMS operation at the Spatone site in North Wales.

▪ When needed to coordinate the review and approval all batch production-related records, including all records for packaging and labeling operations, ensuring that production records are reviewed for completion and errors.

 

Person Specification 

Education / Qualifications

▪ Ideally educated to degree level, preferably from a scientific or life science background with 2+ years relevant experience within a documentation or QMS role for a food or healthcare manufacturing/distribution company

 

Skills and Experience

Essential

▪ Experience with managing a QMS and filing systems

▪ Experience of a QA/Technical role in either food or healthcare product manufacturing.

▪ Experience of QMS Implementation, Maintenance and Development.

▪ Knowledge and practical experience of Good Manufacturing Practice (GMP),Good Distribution Practice (GDP), Good Laboratory Practice (GLP).

▪ Knowledge and practical experience of bulk manufacturing and packaging processes/ equipment.

▪ Numerical, analytical & investigative skills.

▪ Strong interpersonal and communication skills.

▪ Ability to work accurately, with attention to detail.

▪ Ability to prioritise and deal effectively with a varied workload.

Desirable

▪ Experience of herbal/ homeopathic product manufacturing.

▪ Strong Excel knowlege

Behaviours

▪ Team player with strong communication skills

▪ Flexible approach to work and tasks

▪ Approachable and friendly

▪ Confidence to challenge results and performance

▪ Pro-active