Quality Specialist

Eurofins UK BioPharma Services; Portsmouth; On-site; GBP 25,000 - 40,000; Full time

Job summary

A leading bio-pharma services company is seeking a quality management professional to support their QMS implementation and monitoring. The role involves ensuring compliance with cGMP standards, data analysis, and auditing. Candidates should have experience in QMS and technical writing skills, fostering continuous improvement within the organization. This is a full-time position, with a commitment to employee growth and diversity.

Benefits

Enhanced Annual Leave Entitlement

Company Pension Plan

Free Parking

Life Assurance Scheme (4 times annual salary)

Healthcare Cash Plan

Employee Assistance Programme – 24/7

Health and Wellbeing Programmes

Qualifications

• Qualified candidates should have significant experience in QMS.
• Proven ability to present trend reports is required.
• Experience with CAPA and Change Management is essential.

Responsibilities

• Ensure compliance with all relevant cGMP and company procedures.
• Write, review, and amend work instructions as necessary.
• Investigate unexpected results and suggest solutions.

Skills

Attention to detail

Technical writing

Planning and organisation

Written and verbal communication

Teamwork

Education

Experienced in QMS

Experience of writing and reviewing SOPS

Experience in the generation of Non-conformance reports

Job description

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Unfortunately, we are unable to offer visa sponsorship for this role.

37.5 Hours per week. Monday - Thursday. 08:00-16:30. Friday. 07:00-15:30.

Purpose of the Post:

Support the implementation and monitoring of the quality management system in compliance with cGMP and company policies within the facility.

• To ensure compliance with all relevant cGMP, Quality standards and company procedures at all times – this includes reporting any deviations from those standards/procedures
• Write, review and amend work instructions and forms as appropriate in a timely manner.
• Check laboratory data, records and log books to ensure they are completed correctly.
• Investigate unexpected results, errors or problems in methods and offer suitable solutions.
• Perform data trending and use technical expertise to make suggestions for continuous improvement
• Communicate effectively at all levels in the company, ensuring management are kept informed of potential issues, work progress and problems.
• Assist in the generation of the monthly quality report for review at management meetings.
• Assist in the management of the internal auditing programme, as well as performing internal auditing.
• Assist in the coordination and tracking of all calibration activities for equipment to ensure compliance to schedules.
• Support in the company validation activities and ensure all critical equipment is fully validated
• Generate validation protocols and validation summary reports as required
• Ensure that the appropriate training has been carried out in order to produce and sustain high levels of performance and be responsible for your own training and development.
• Review results forms, certificates of analysis or technical reports as required.
• Generate, review and approve validation protocols and validation reports as required.
• Ensure the retention and security of all quality records in conjunction with the quality manage
• Assist in the management of the vendor approval scheme, including supplier quality questionnaires and conducting supplier audits for both suppliers and subcontractors.

Job Description

Unfortunately, we are unable to offer visa sponsorship for this role.

37.5 Hours per week. Monday - Thursday. 08:00-16:30. Friday. 07:00-15:30.

Purpose of the Post:

Support the implementation and monitoring of the quality management system in compliance with cGMP and company policies within the facility.

• To ensure compliance with all relevant cGMP, Quality standards and company procedures at all times – this includes reporting any deviations from those standards/procedures
• Write, review and amend work instructions and forms as appropriate in a timely manner.
• Check laboratory data, records and log books to ensure they are completed correctly.
• Investigate unexpected results, errors or problems in methods and offer suitable solutions.
• Perform data trending and use technical expertise to make suggestions for continuous improvement
• Communicate effectively at all levels in the company, ensuring management are kept informed of potential issues, work progress and problems.
• Assist in the generation of the monthly quality report for review at management meetings.
• Assist in the management of the internal auditing programme, as well as performing internal auditing.
• Assist in the coordination and tracking of all calibration activities for equipment to ensure compliance to schedules.
• Support in the company validation activities and ensure all critical equipment is fully validated
• Generate validation protocols and validation summary reports as required
• Ensure that the appropriate training has been carried out in order to produce and sustain high levels of performance and be responsible for your own training and development.
• Review results forms, certificates of analysis or technical reports as required.
• Generate, review and approve validation protocols and validation reports as required.
• Ensure the retention and security of all quality records in conjunction with the quality manage
• Assist in the management of the vendor approval scheme, including supplier quality questionnaires and conducting supplier audits for both suppliers and subcontractors.

Qualifications

• Experienced in QMS
• Ability to complete and present trend reports.
• Candidate should have excellent;
• Attention to detail.
• Technical writing skills
• Planning and organisation
• Written and verbal communication
• Working on initiative and with a team
• Candidate should have Experienced in working within QMS.
• Experience of writing and reviewing SOPS.
• Experience in the generation of Non-conformance reports, CAPA and Change Management

Additional Information

Benefits

At Eurofins we are growing, innovating and always learning. We celebrate the achievements of our employees through annual long service awards, recognise our colleagues special life events, and we are committed to charitable causes through global fundraising activities.

As a Eurofins employee you will benefit from:

• Enhanced Annual Leave Entitlement
• Annual Leave Sellback Scheme
• Additional Annual Leave at Employees set service dates
• Company Pension Plan
• Free Parking
• Life Assurance Scheme (4 times annual salary)
• Healthcare Cash Plan (6+ months service)
• Enhanced Maternity, Adoption and Paternity Schemes
• Employee Assistance Programme – 24/7 confidential
• Health and Wellbeing Programmes
• Worldwide career opportunities
• We also have in place rewards recognising the great work ouremployees deliver, their dedicated service and celebrating special life events.

What Happens Next
Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths.

Your data
As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.

Closing Date
We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible.

Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately, on this occasion your application has been unsuccessful.

We support your development!Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development.

Weembracediversity!Eurofins network of companies believe in strength and innovation through diversity, being anEqual Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.

Sustainability matters to us!We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal!

Find out more in our career page:https://careers.eurofins.com/