Quality Assurance Manager QMS
- Reference: QA QMS
- Location: South Wales
- Salary: Upto £60000
- Type: Full time
- Start: asap
Just Life Sciences are seeking a Quality Assurance Specialist who has substantial QMS experience, working for an International Pharma company, you will lead and manage the Quality Management Systems and Quality Validation oversight sections of the Quality Department to ensure the successful implementation and maintenance of the company Quality Management System, including validation and internal /external audits. The job holder has direct people management responsibilities for their team members and ensuring that all KPIs, targets and any other deadlines are met individually and by the team.
Should you be successful you will be involved with
Qualifications, Skills and Experience
- Technical/Quality Assurance
• Management of the Quality Systems Management Team.
• Manage all validation quality oversight related activities.
• Work in conjunction with all group departments, to develop and implement Quality Assurance systems to ensure
compliance with all applicable EU directives.
• Implement and maintain Quality Risk Management systems to ensure that risks are adequately controlled in accordance with current requirements.
• Maintain the company audit programmes with regard to internal and external audits.
• Ensure appropriate investigations of deviations, errors, complaints, failures and adverse events requiring documented review and action.
• To review non-compliance identified by audit, deviations and complaints and use technical / professional
judgement to make appropriate product quality decisions (in association with site QP’s) and initiate and
promote quality improvements.
• To provide key performance indicators for review by the Director, Quality and initiate corrective and
preventative actions based on this data.
• Ensure that staff within area of responsibility comply with company Health and Safety Policies and
• To manage team performance and absence standards, including coaching, counselling and disciplinary
measures as required. To conduct performance appraisal and to set targets and objectives for individual
members of the group.
• Ensure that all staff appraisals within the area of responsibility are conducted in a timely manner and in line
with the approved Human Resources Policy.
• To manage the training requirements within the group to ensure regulatory compliance and business needs
• To identify development needs for team. In conjunction with HR, to develop training plans and budgets.
Qualified to at least first degree level in Chemistry, Pharmacy or Microbiology or allied sciences.
Qualified Person status desirable but not essential but working towards QP status would be an advantage.
Experience in a similar role in the Pharmaceutical Industry with up to date credentials relevant to both investigational (clinical trial) and marketed (commercial products).
Excellent interpersonal skills being able to communicate effectively with a wide range of individuals and groups.
Proven ability and desire to continuously improve, by seeking new approaches, generating ideas & demonstrating a
determination to secure business advantage from such initiatives.
Proven ability to plan effectively, by taking a long-term view and developing structured action plans to meet
Must be able to effectively manage multiple tasks simultaneously.
Must be a completion driven individual, with the attitude to drive projects to completion in considerable detail.
Must be able to initiate and implement change and achieve the buy-in of all staff via strong influencing skills
- If you have the experience or are looking for a new challenging role within the Life Sciences Sector then please email your CV to justyn at justlifesciences dot com
Just Life Sciences
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