Quality Assurance Manager
- Employer
- Proclinical Staffing
- Location
- Homeworking
- Salary
- Negotiable
- Start date
- 15 Feb 2021
- Closing date
- 1 Mar 2021
View more
- Discipline
- Quality, QA / QC
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
A trail blazing and fast paced pharmaceutical company are in search for a Quality Assurance Manager. This organisation is dedicated to developing new products, this role is for an innovative QA Manager who will thrive on making things happen. Job Responsibilities- Develop and improve quality management systems for the clinical interventional and non-interventional research, based on current best practices in industry;
- Provide leadership and guidance during EMA and FDA health authorities inspections; Prepare and organise responses to regulatory agencies partners
- Develop and implement tools for quality risk management that can be applied to different aspects of
- pharmaceutical quality.
- Ensure the high level of the vendor selection, qualification and monitoring process
- Manage and trend the deviation process while ensuring that a thorough investigation report is completed in a timely manner using proven root cause analysis tools.
- Manage commitments to ensure timely completion of the outlined tasks and effectiveness.
- Promote a culture that supports continuous improvement through active communication and functional area participation.
- Investigate and address identified compliance and quality issues and develop solutions to correct known and potential compliance and quality concerns.
- Support QA activities may also include conducting international audits, maintaining quality databases and performing trend analysis, reporting metrics, performing quality and compliance training (as needed), developing and updating SOPs, specifications, policies and/or other quality documents as needed.
- 10 or more years' experience in a technical role in quality assurance, manufacturing, analytical testing or engineering with at least 5 years in a related management role
- Significant background acquired in pharmaceutical company
- Significant experience of EMA and FDA inspections
- BS in Engineering, Chemistry, Biological Sciences or related field with an education or training in cell culture and gene therapy a plus
- ASQ Auditor certification, ASQ Quality Engineer certification preferred
- Fluent in English
Company
At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.
Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives.
ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating.
Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.
- Website
- https://www.proclinical.com/
- Telephone
- 0800 988 4437
- Location
-
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom
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