Quality Operations Manager
2 weeks ago
Are you an experienced Quality Operations Manager, with an excellent understanding of processes and issues relevant to their area of expertise (QC, Chemistry, & Plant). As well as a strong understanding of cGMP, Good Documentation Practices and Data Integrity (e.g. ALCOA principles) ? If so this could be the opportunity that you are looking for.
Role: Quality Operations Manager
Role Type: Permanent
Hours: Full-time, 40 hours per week, Monday to Friday
Salary: Competitive Salary, plus we offer a fantastic benefits package and annual bonuses.
Location: Milton Park, Abingdon, Oxfordshire, OX14 4RZ
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.
As Quality Manager your Primary Responsibilities will include
- Managing, training and mentoring the team
- Coordinating and supporting the day-to-day running of the team
- Training the use of data gathering and problem solving tools
- Providing metrics on Operational KPIs
- Promoting a right-first-time approach to all documentation
- Drives improvement for QA processes and company and operational KPIs and supports other functions in doing so
- Defines clear training and development plans for the team and follows up to ensure adherence
- Conduct regular 1:1s and performance reviews
- Ensure direct interaction of the team members with relevant areas in order to maximise interdepartmental collaboration
- Monitors the performance of the team in relation to deliverables for client projects.
- Ensures a proactive and constructive approach to QA processes
Additional Responsibilities & Skills
- Support and coach originators of Change Controls, Deviations, Laboratory Investigations or OOS/OOT into initiating the process and completing the associated form
- Suggest innovative and practical ideas/solutions to problems
- Ability to lead teams in project related work
- Excellent time management / organisational skills in order to perform their job efficiently
- Requires minimal input from line management in order to achieve planning/deadlines
- Significant experience in a technical background
- Excellent understanding of processes and issues relevant to their area of expertise (QC, Chemistry, Plant), and awareness/understanding of other areas to enable investigations in those areas are progressed and completed
- Very good understanding of cGMP, Good Documentation Practices and Data Integrity (e.g. ALCOA principles)
- Excellent technical writing skills
- Excellent interpersonal and communication skills to be able to interview colleagues who reported issues with diplomacy and motivate the same colleagues into addressing the issues
- Excellent relationship building skills to develop rapport with QA and Operational Units, and create a partnership working environment
- Ability to prioritise activities within the team in order to support quality, compliance and business needs
Other skills or attributes
- Promote a quality culture throughout the working environment
- Right First Time quality mentality
- Delivery focused
- Approachable
- Pragmatic
- Appropriate risk based assessment of issues and ability to provide alternative strategies and independent thought processes
- Enthusiastic, keen learner with passion to deliver work of a high standard within the quality (cGMP) standards
- Good problem solving skills
- Good organisational skills relating to management of associated daily activities
- Ability to allocate and utilise resource to ensure completion of projects on time
- Ability to take responsibility for technical decisions
- Conflict management and resolution orientated skills
- Ability to support internal audits and GMP audits as front speaker
Company Benefits
- Pension on completion of (but not subject to) your 3-month probationary period. Contributions 6% for employees (salary sacrifice) and 6% 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 and additional length of service days awarded on the anniversary, up to a maximum of 30 days
- Private health insurance with BUPA for the employees and their partner/family under the company scheme
- Private dental cover, after 3 months of service
- Life assurance at four times your annual base salary
- Well being support 24/7 and counselling services
- Permanent health insurance provides 75% of the base salary after the qualifying period.
- Eligibility to participate in the Company Bonus Scheme. This is a discretionary benefit.
- Excellent training and support and continuing professional development opportunities.
- Cycle-to-work scheme
- Refer a friend scheme, team and annual events, recognition awards and many more
Onsite Facilities
- On-site parking and discounted gym
- Subsidised Restaurant, which offers an excellent breakfast and lunch selection
- Good public transport links with bus service
If you are Interested?
Please apply NOW – uploading your up-to-date CV and cover letter to Workday
Job Types: Full-time, Permanent
Work Location: In person
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