Job Description
We have a truly unique position available within our Abingdon site! Are you an experienced Audits and Inspections Quality Specialist? A skilled influencer with highly tuned attention to detail, who is looking to be part of transforming the quality team in the UK into something genuinely special? If you are working within pharmaceutical, life sciences, or ResearchServices (CRO) with GMP knowledge (regulations MHRA and FDA) Do you want to influence and be part of the global quality team? If so, then this could be an opportunity for you!
Role: Quality Specialist, Audits, and Inspections, permanent
Direct report: Quality Audits Manager
Hours: Full-time, 40 hours per week, Monday to Friday, Days only.
Salary: starting from £45,000pa, dependant on qualifications and experiences, plus we offer a fantastic benefits package and annual bonuses.
Location: Milton ParkOxfordshire, OX14 4RZ.
Please be aware this is an office-based role with some global travel involved as required.
Our Company
Evotec, Aptuit’ s parent company, is a leader in the discovery and development of novel therapeutics of all modalities with operational sites in the UK, Europe (Germany, Italy and France) as well as the US. Aptuit Oxford provides integrated Chemistry, Manufacturing and Control capabilities to fully support drug substance development and GMP manufacturing on both laboratory and commercial scales for Active Pharmaceutical Ingredients.
An exciting opportunity has arisen to join our dynamic quality specialist team. You will be working with a high-performing and friendly team focused on internal and external audits and inspections – the person who holds this position will be the main point of contact for supplier qualifications and will perform the supplier audits.
Role and Responsibilities for our Quality Specialist, Audits, and Inspections
You will be part of a fast-paced Quality specialist team. Carrying our audits and inspections across a range of functions. Implementing methodology. A key focus of the role is leading internal and external (supplier) audits and hosting on-site client audits. Ensuring taking the leading role in executing and supporting the day-to-day running of the department and supporting the Audit & Inspection team during all audits and regulatory inspections.
Key Responsibilities
- Provide Quality Assurance guidance and coaching to other departments to ensure compliance Consistently performs the tasks that are assigned to their role within Quality Assurance
- Consistency in results generated and routine performance to inspire trust and confidence in the work they are requested and expected to perform
- Comprehensive understanding of cGMP procedures, how they relate to the larger regulatory environment and an ability to place them in context.
- Identifies and prioritises assigned work and that of junior members of the QA team.
- Builds effective working relationships with members of other departments to ensure the successful completion of tasks in line with business requirements through a partnership approach.
- Generation and review of Quality Assurance procedures and other documentation.
- Identifies & takes action to resolve issues as they arise across the site. Adopts a leading role in the root cause analysis and driving effective CAPA to prevent a recurrence.
- Monitoring Quality KPI’s - Monitor activities and identify trends, set in place action plans to resolve identified trends and report results to site Quality Management.
- Attend training as required to develop knowledge and skills. Commits time & effort to learn new skills or approaches.
- Trains and coaches junior members of the QA team, and site personnel, to develop & apply what they learn to their jobs.
- Maintain and share with colleagues as appropriate, personal knowledge of GMP and current industry practice.
- Seeks continuous quality and process improvement in QA and site practices and deputises for QA Manager as appropriate.
Key Tasks (Compliance)
- Writing risk assessment documents for internal and external audit schedules.
- Lead internal and external audits and support external client audits/regulatory inspections.
- Generation and monitoring of KPI’s.
- Maintenance of QMS.
- Review/approval of deviations, CAPAs, change controls, out of specifications and laboratory investigations.
- Assist other departments in root cause analysis and data integrity reviews.
- Issue documentation and carry out biennial document reviews.
- Supplier assurance activities and approval of supplier questionnaires.
Skills & Competencies
- Highly influential leader with the ability to forge strong and lasting relationships, and an approachable nature who can really support and develop within the team.
- Can demonstrate continued professional development within overall Quality Auditing and Inspections.
- Ability to work with and manage a closely interacting team to deliver to tight timelines.
- Lead complex projects with cross-site and cross-discipline activities.
- Excellent interpersonal and communication skills, including remote interactions, as well as good organisational and time management abilities.
- Comfortable with external interactions with leadership and stakeholders.
- Strong attention to detail and excellent data capture and analysis standards as well as written and oral presentation skills.
- Problem-solver with a strong ability to implement new ideas and best practices.
- Highly adaptive and able to work effectively in a fast-moving and high-growth environment.
- Ability to drive change by providing clear plans and objectives for the team and key stakeholders.
- A natural enjoyment of working with people, highly empathetic and connecting with those that do the job along with their leadership.
- Enthusiastic and flexible, positive ‘go the extra mile’ approach.
Education and Experience (essential)
- BSc degree or equivalent with ideally 3 year’s experience working as a Lead Auditor in GMP (regulations MHRA and FDA) environment. The experience could be from within a pharmaceutical company, Biotech, CRO.
- Excellent communication skills – clear, and timely written & verbal communication.
- High attention to detail which supports a “right first time” culture.
- Comprehensive knowledge and technical competence in Quality Assurance.
- Excellent time management/organisational skills in order to achieve planning/deadlines.
- Be resilient and resourceful taking a flexible approach and demonstrating initiative.
- An ability to work independently or as part of a team.
- Ability to actively participate in meetings and support QA projects.
- Exhibits excellent critical thinking, the ability to risk assess problems and prioritise actions according to risk, and Root Cause Analysis.
- An ability to generate and implement solutions to both department and site issues.
- This is an on-site role with some travel expected for supplier audits.
Experience – Desirable
- A certified Lead Auditor to ISO 9001.
What we offer you in return
We offer a competitive salary and benefits package.
- Company pension scheme with matched contributions from the company up to 7.5%.
- 25 days holiday plus bank holidays and additional length of service days awarded on the anniversary, up to a maximum of 30 days.
- Private health insurance with BUPA for the employee and their partner/family under the company scheme.
- Group life assurance – four times the employee’s annual salary and is valid for the whole of their employment with the company. The costs are borne by the company.
- Dental insurance with UNUM for the employee, cover can also be provided for their partner/family at the cost to the employee.
- Wellbeing support 24/7 and counselling services
- Permanent health insurance providing 75% of base salary after the qualifying period.
- Eligibility to participate in the Company Bonus Scheme. This is a discretionary benefit.
- Refer a friend scheme, team and annual events, recognition awards and many more!
- Career progression within the company - we have excellent training and support and continuing professional development opportunities.
- Cycle to work scheme.
- Gym and workout studio, running, walking, and cycling routes.
- Workplace nursery.
- Restaurant, café on-site and on the main campus.
- Good public transport links with the shuttle bus service to Didcot Train Station.
- Free parking.
Interested?
Apply NOW – please upload your up-to-date CV and cover letter to Workday.
If you have any questions, please contact Sarah Lomas, Recruiter on s.lomas @cyprotex. com.
To view our current vacancies and more information about the company visit our website at Career - Evotec.
Evotec is proud to be an equal opportunities employer, welcoming individuals regardless of age, gender, sexual orientation, marital status, race, nationality, religious denomination, or disability. We match our role based on your suitability and experience.
Candidates must have the right to work in the UK. We will consider European applications with the right skills and experience. All roles will be subject to a security screening check.
Due to the high volume of applications, we may close this vacancy at any time once we find our perfect match.
**Direct applications only, no agencies **
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Job Types: Full-time, Permanent
Salary: From £45,000.00 per year
Benefits:
- Casual dress
- Company events
- Company pension
- Cycle to work scheme
- Discounted or free food
- Employee discount
- Flexitime
- Free parking
- On-site parking
- Private dental insurance
- Private medical insurance
- Referral programme
- Wellness programme
Schedule:
- Flexitime
- Monday to Friday
Supplemental pay types:
- Performance bonus
- Yearly bonus
Ability to commute/relocate:
- Abingdon, OX14 : reliably commute or plan to relocate before starting work (required)
Application question(s):
- Please confirm you have BSc degree or equivalent with ideally 3 year’s experience working as a Lead Auditor in GMP (regulations MHRA and FDA) environment. The experience could be from within a pharmaceutical company, Biotech, CRO.
- Please confirm you have a certified Lead Auditor to ISO 9001.
Education:
- Diploma of Higher Education (required)
Experience:
- Quality Specialist, Audits, and Inspections: 3 years (required)
Work Location: In person
Reference ID: JOB ID-07996