Compliance Officer

1 month ago

Abingdon, United Kingdom Evotec Full time

Aptuit Oxford Limited is a drug development expertise and capabilities to pharmaceutical and biotechnology companies as well as to academic institutions. The company is a wholly owned subsidiary of Evotec SE.

Job Title: Compliance Officer

Location: Milton Park, Abingdon

**Salary**: up to £36,000, plus excellent company benefits

Job Purpose:

- To support the Pilot Plant in all Production compliance operations and to support the timely completion of all quality KPI documentation.

Health, Safety and the Environment:

- Ensure that plant safety is maintained, and safety procedures are adhered to, including:

- Promoting a culture of Health and Safety first, directly and through Health and Safety Representatives.
- Ensuring unsafe conditions are identified, reported, and made safe.

Quality
- Author and review pilot plant documentation (such as IOPs, FRMs, LSTs, REPs, RCGs) and perform updates where required.
- Prepare and complete the following Quality documents to support Pilot Plant operations:

- CAPAs
- RCFs
- DEVs
- Trend KPIs for Deviations, CAPAs, and RCFs and support production in the completion of documents for approved timeframes.
- Support production management with internal, external client and regulatory audits.
- Ensure periodic reviews of procedural documentation are completed on time for Production Department.
- Support QA with reviews of purified water systems in relation to microbial testing, TOC and conductivity levels raising any deviations or water forms as required.
- Support Production with purified water sampling to ensure correct and timely submission of samples to external testing laboratory.
- Assist other departments on site, where appropriate, with quality related issues.

Operational Excellence
- Identify areas where improvements can be made (e.g. to reduce errors or improve quality effectiveness/efficiency) and implement improvements by planning/leading projects to support continuous improvement

Learning
- Identify own training requirements and participate fully and diligently in all training opportunities.
- Ensure training is recorded accurately in training record, including:

- Ensure training records are completed promptly to avoid training elements becoming overdue.
- Only perform tasks that are appropriately signed-off in the training record.
- Plan, prepare and deliver training when required for new/improved procedures.

Technical Capability
- Maintain full familiarity with Pilot Plant operations for GMP compliance.
- Provide guidance and support on quality issues to staff and participate in the running of processes and related works if required.

Delivery
- Plan and prioritise own workload.
- Perform weekly checks of both pilot plant for compliance and liaise with Shift Managers (and Shift Supervisors) to ensure that the production schedule and quality of work are maintained.
- Undertake any other reasonable management requests (as required).

Other Skills
- IT literate with strong Microsoft Office skills.
- Familiarity with Universal Viewer and SCADA systems.
- Strong experience, knowledge and understanding of cGMP.
- CAPA/RCF/Root cause analysis trained
- Experienced in change management and the ability to drive change and support individuals, teams and the organization in making changes.

In return we can offer you
- Company Pension Scheme.
- 25 days holiday plus bank holidays & an additional 1 day for each year completed up to a maximum of 30 days.
- Private Health Insurance for you, your partner/family under the company scheme.
- Private Dental Care Scheme.
- Health Insurance providing 75% of base salary after a qualifying period.
- Wellbeing support 24/7 and counselling services.
- Eligibility to participate in the Company Bonus Scheme (This is a discretionary benefit)
- Cycle to work scheme.
- Refer a friend scheme, team and annual company events, recognition awards and many more
- Free onsite parking.
- Restaurant which is highly subsidised.
- Great transport links from Oxford and the surrounding area's as well as a shuttle bus service from Didcot train station.
- Milton Park also offer’s great cycling, running & walking routes as well as annual events.
- We have excellent training and support and continuing professional development opportunities.

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