Quality Specialist II
Quality Specialist II
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Job Description
Are you an experienced Quality Specialist looking for a new opportunity working within a global Pharmaceutical organisation if so this maybe the role for you.
We are looking for a highly motivated Quality Specialist II to join our team who are based at Milton Park in Abingdon Oxfordshire (UK)
Role: Quality Specialist II
Job Type: Permanent
Working Hours: 40 hours per week Monday to Friday
Salary: Competitive salary as well as excellent company benefits
Location: Milton Park Abingdon Oxfordshire UK
Evotec is a leader in the discovery and development of novel small molecule with operational sites in Europe and the US. The Company has built substantial drug discovery expertise and an industrialised platform that can drive new innovative small molecule compounds into the clinic. In addition Evotec has built a deep internal knowledge base in the treatment of diseases related to neuroscience pain oncology inflammation and metabolic diseases. Leveraging these skills and expertise the Company intends to develop bestinclass differentiated therapeutics and deliver superior sciencedriven discovery alliances with pharmaceutical and biotechnology companies.
Primary Responsibilities will include :
- Provide Quality Assurance guidance and coaching to other departments to ensure compliance to Aptuit policy best practice and cGMP.
- Producing results inline with Aptuit policy best practice and cGMP in the desired time frames as directed by Line Manager.
- 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. C
- Comprehensive understanding of cGMP procedures how they relate in the larger regulatory environment and an ability to place them in context.
- Displays a good knowledge of Aptuit QC and manufacturing equipment utilities facility design cleaning maintenance qualification validation material management onboarding and supplier qualification.
- Builds effective working relationships with members of other departments to ensure successful completion of tasks in line with business requirements through a partnership approach.
- Project involvement arranges and participates in meetings and project team activities.
- Generation and review of Quality Assurance procedures and other documentation.
- Identifies & takes action to resolve issues as they arise across site. Supports in the in the root cause analysis and driving effective CAPA across all areas of the business to prevent recurrence.
- Monitoring Quality KPIs Monitor activities and identify trends sets in place action plans to resolve identified trends and reports results to Line Manager.
- Participate and support internal audits and external audits/inspections.
- Attend training as required to develop knowledge and skills. Commits time & effort to learn new skills or approaches.
- Trains 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.
Key Tasks
- Review and approval of QC method validation.
- Initial review of minor deviations and completion of owner sections of deviations. Initial review of change controls and CAPAS.
- Review and approval of OOS.
- Review of LIFs. Assist other departments in root cause analysis.
- Review and approval of protocols and reports for stability and forced degradation studies.
- Review and approval of COAs for AWSs non GMP materials specifications for RMs NTs PAs and PKs.
- Issue documentation and carry out biennial document reviews.
- Preparation of Product Quality Reviews.
- Production batch record reviews (executed and master records).
- Prepare COA/GMP statements BSE/TSE and other certifications and statement of results.
- Release of intermediates.
- Manufacturing cleaning documentation reviews and decontamination certificates.
- Review production logbooks in line with Quality standards.
- Review and approval of production equipment (minor changes qualifications calibration).
- Review and approval of specifications for RMs NTs PAs and PKs.
Skills
- Must have previous experience within QA and GMP
- Excellent communication skills.
- High attention to detail.
- 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 demonstrate 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.
Company Benefits Include
- Pension on completion (but not subject to) of your 3month probationary period. Contributions 5 for employees (salary sacrifice) and 5 for the employer. The employee can opt to increase their contribution and the employer will match the increase up to a maximum of 7.5.
- 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.
- Well being support 24/7 and counselling services.
- Excellent career progression opportunities within the company; we have an excellent training and support and continuing professional development opportunities.
- 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!
As well as
- Free onsite parking.
- Restaurant which is highly subsidised.
- Great transport links from Oxford and the surrounding areas as well as a shuttle bus service from Didcot train station.
- Milton Park also offers great cycling running & walking routes as well as annual events.
FR : Dans le cadre de sa politique Diversit Evotec tudie comptences gales toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy Evotec considers with equal competences all applications including people with disabilities.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
