Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): On Application
Quality Operations Manager Location: Swindon. Salary: Highly competitive; car allowance + performance based bonus + further company bonuses. Our client are going through a transformational change and are now at a period where they are quickly growing and want to bring in an inspirational spearhead to lead their charge for ongoing success.
Quality Operations Manager
Salary: Highly competitive; car allowance + performance based bonus + further company bonuses
Our client are going through a transformational change and are now at a period where they are quickly growing and want to bring in an inspirational spearhead to lead their charge for ongoing success. This role is looking for an experienced Quality Operations Manager who can take responsibility for the Quality Operations Team, which will consist of QA Officers and Qualified Persons. This means the Quality Operations Manager will be in charge of driving effective, complaint and safe management of the Quality Assurance function of the operational areas within the company's site.
Responsibilities (to include, but not limited to):
*Guaranteeing that products are manufactured in accordance with GMP, Standard Operating Procedures and all other pertinent regulatory requirements.
*Evolving and driving improvements in KPIs, targets, plans and your personal team aims and align these with the wider Quality Team and Business.
*Preserving thorough understanding of ISO, international regulatory guidance, client and corporate requirements relevant to the site. In addition to ensure that all work within the Quality department and throughout the aligned cell complies with these and departmental procedures.
*Dealing with completion of all documentation (statutory, regulatory and GMP) to the required standard and timescales, to ensure effective and appropriate service for their internal and external clients
*Performing Qualified Person (QP) responsibilities
*Proactively drive and respond to system trending (e.g. complaints, environmental and deviations) to certify ongoing quality performance.
*Safeguarding suitable staff training and development programmes are in place and implemented to guarantee competency (appropriately experienced and qualified personnel) and support the achievement of objectives.
*Sustain a state of readiness for regulatory agency and third party audits.
*Ensuring new equipment, products and processes are meritoriously introduced to internal and external standards.
*Sustaining and establishing effective communication with clients to ensure that the management of complaints and queries takes place to match internal and external client expectations.
*Minimum Degree in Chemistry, Pharmacy or Microbiology
*Eligible to act as a ‘Qualified Person' as defined in 2001/83/EC and 2001/82/EC (as amended)
*Excellent working knowledge of the principles and guidelines for GMP.
*Up to date understanding of regulatory expectations.
*Experience of developing and influencing business strategy
*Excellent scientific and technical knowledge
*Experience of leading and evolving a team.
If however, you do not feel that this is the right role for you, please forward these details on as we have a generous referral scheme in place.
Please note due to the high level of applications if you are not contacted, you have not been successful on this occasion.
Key Words: GMP, GXP, QA, Quality Assurance, QMS, RP, Inspections, QP, Audit, Inspection Readiness, Batch Release, Batch Certification, MHRA, Compliance, QMS, Manufacturing, Responsible Person, Qualified Person, Quality Management Systems, Swindon, Operations Manager, Products, Reading, Oxford, Oxfordshire, Berkshire, Slough, Maidenhead, Bath, Bristol, Newbury, Basingstoke, Southampton, Guildford, Bracknell, Wiltshire
3rd floor 33 Blagrave Street Reading
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