Quality Assurance Officer - Hay, United Kingdom - GMP Recruitment Ltd
Description
GMP Recruitment are currently looking to recruit a Quality Technician for a hugely successful manufacturing company located in Hay-on-Wye, on a full time, permanent contract.
The working hours for this position are as follows:Monday - Friday: 08:00am - 16:00pm
As a Quality Assurance Officer, you will support the overall implementation and maintenance of the Company's quality management systems and adherence to cGMP.
Quality Assurance Officer Main Duties:
- Preparation / authorisation of Master BPRs, artwork, component specifications, labels, reprocessing paperwork, prebatch documentation, calibration records, temperature records, environmental reports, MWOs, etc.
- Liaison with customers on issues relating to quality matters, presenting quality related data and attending and presenting at quality review meetings.
- Assist with initiating any nonconforming events within the QMS.
- Advise Senior Quality personnel of any deviation / nonconformance / abnormality observed with finished product or major nonconformance against procedure.
- Complete minor complaint investigations, identify root cause and robust CAPAs to eradicate reoccurrence of issue.
- Review and approval of deviation reports ensuring that root cause analysis has been completed and robust actions have been identified to eradicate reoccurrence of an issue.
- Communicate nonconformances with clients. Work with clients to request investigations for client nonconformances, close out when investigation complete.
- Send internal Events / Deviations reports to clients in conjunction with the Quality Technical Agreement requirement. Seek approval where required.
- Review of complaint investigations. Seek approval from clients on investigations as per QTA requirement.
- Assisting with review of CAPA evidence and complete CAPA effectiveness reviews.
- Support with change control review and approval process. Send change control notifications to clients and seek approval where required.
- Assisting / Hosting / supporting client / regulatory visits / audits. Support with audit responses.
- Internal auditing to confirm compliance to EU GMP and adherence to company procedure and policy.
- Assist in preparation of monthly report and other reports as required e.g. client requested information.
- Support NPI QA lead with Commercial and Clinical New product introduction from a quality perspective.
- Relevant experience gained within a quality role, or highly regulated industry
- Good administrative and organisational skills
- Quality focussed with a high level of attention to detail
- Good IT skills, proficient in the use of MS Outlook, Word and Excel
- Competent in both written and verbal communication
- Ability to prioritise tasks and work to deadlines
- Able to identify and solve problems
- Logical
- Proactive
- Able to work as part of a team, or alone
- Good interpersonal skills; Approachable, reliable, honest, trustworthy, collaborative, listening skills & able to consider and be open to feedback
Note:
due to location, a driving licence is essential for this position.
If you are a good communicator who is enthusiastic, reliable and has a great attitude towards their work, then this is a great opportunity to join a fast growing and successful manufacturing business that offers great career progression and support.
Job Types:
Full-time, Permanent
Benefits:
- Company pension
- Free parking
- Onsite parking
- Referral programme
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Hay: reliably commute or plan to relocate before starting work (required)
Experience:
- Quality assurance: 1 year (required)
Work authorisation:
- United Kingdom (required)
Work Location:
One location
Reference ID:
J1289
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