Quality Assurance Lead

4 weeks ago

Gosport, United Kingdom Wickham Micro Full time

With over 60 years of global experience, Wickham Micro Limited are a world leader in providing contract microbiology services to the pharmaceutical and medical device industry; ensuring the products we test are safe and effective for their intended use.

Our Company is a great place to work, and we want you to enjoy working with us. There are various ways in which you can progress, whether you wish to become a Subject Matter Expert in a particular area or climb the ladder and become a more senior member of the team - you tell us, and we will work with you to help you achieve your goals

**About the Role**:
An exciting opportunity has arisen at our Head Office in Gosport for a Quality Assurance Lead within our Quality Assurance department on a full time basis, working 8am - 4pm Monday - Friday with occasional overtime and weekend work.
- To work in compliance with GLP, GMP and the policies and procedures of our Quality System.
- Provide support across departments on Quality related processes.
- QA review of technical Protocols, Final Reports and raw data.
- QA lead of Out of Specifications (OOS), Non-Conformance Reports (NCR), Corrective and Preventive Action (CAPA).
- Conduct progress checks of Out of Specifications (OOS), Non-Conformance Reports (NCR), Corrective and Preventive Action (CAPA) advising of any trends or concerns to the quality management team.
- Lead GEMBA walks.
- Drive Quality Root Cause Analysis tools across the Company, supporting knowledge and training in problem solving.
- Undertake the QA review and approval of Risk Assessment, Change Control, IQ, OQ, PQ and Post Implementation.
- Conduct periodic reviews/audits of GXP computerised systems.
- Update Quality databases and produce data reports and KPI’s monthly advising of any trends or concerns to the quality management team.
- Lead internal inspections/audits of departments for compliance with Good Laboratory Practice, Good Manufacturing Practice and other quality standards.
- Lead supplier audits as part of the supplier approval process.
- Provide support to initiate, engage and escalate critical and major compliance issues through the QMS processes.
- Co-host client / regulatory inspections.
- Regular review of relevant pharmacopoeias and standards, conducting gap analysis.
- Maintain the EQMS platform, providing training and workshops to end users.

**Salary: Starting salary £25,000 depending on experience**

We are looking for an enthusiastic people person who can work both individually and as part of a friendly and knowledgeable team. If you’ve got a can-do attitude and are eager to learn, develop and grow with us then we would love to hear from you

**The Must Haves**:

- A minimum of 5GCSE’s or equivalent, including Maths, English and Science.
- Knowledge of the MS Office suiteand Outlook, in particular Excel is essential.
- Previous experience in conducting and leading root cause analysis investigations.
- EQMS platforms (such as Master Control)
- In depth knowledge of GMP/GLP.

**Desirable Skills**:

- Previous laboratory experience is desirable but in no way essential as full training will be provided.
- Ability to follow Standard Operating Procedures within a similar setting.
- Understanding of computerised systems within a GXP environment and GAMP 5 requirements.
- Electronic Quality Management Systems knowledge.

**Key Human Skills**:

- An enthusiasm for continued professional development.
- Able to communicate effectively and work collaboratively with others within the team and across other departments.
- Adaptable and accomplished in managing your workload in order to meet deadlines.
- Exceptional attention to detail and accurate data recording.
- Willingness to use your initiative to overcome challenges and bring fresh ideas to the table.

Our benefits package seeks to reward you for your dedication and commitment.

**Here’s what we can offer you**:

- A generous 24 days’ holiday plus bank holidays which increases based on length of service.
- Option to purchase up to 3 additional days’ holiday each year.
- Occupational sick pay scheme.
- An additional day off for your birthday (upon successful completion of your probationary period).
- Auto-enrolment into our Pension scheme.
- Cycle to Work scheme.
- Health and wellbeing support through our Employee Assistance Programme.
- Plenty of free on-site parking.
- Free tea, coffee, hot chocolate and fresh fruit.
- Option to be part of our Medical Cashback Scheme (upon successful completion of your probationary period), allowing you to claim back on things such as dentist fees, opticians, physiotherapy, counselling and much more.
- Life assurance.
- Company events from ‘Summer Shindigs’ to the occasional visit from the ice cream van for a lunch time treat
- The opportunity to be part of an experienced team that is constantly evolving with the Company.

**Applications will only be accepted from individuals who are eligible to live and work within the UK**
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