Senior QA Specialist
- Employer
- Proclinical Staffing
- Location
- Germany, Munich, Bayern
- Salary
- Negotiable
- Start date
- 7 Apr 2021
- Closing date
- 21 Apr 2021
View more
- Discipline
- Quality, QA / QC
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
- Implement Product Monitoring, Product Recall, Product Complaints, etc. in time for commercial production
- Reviews and approves controlled documents for GMP compliance, such as master batch records, test methods, trend reports and product specifications.
- Make batch disposition recommendations to the Qualified Person based on reviews of executed batch records, non-conformance events (e.g. out-of-specifications of raw materials or drug substance) and supporting data.
- Lead complex deviation investigations and collaborate with technical teams and external contacts to align compliance expectations and support follow up actions.
- Use basic project management tools to track actions and timelines.
- Interface with regulatory agencies, suppliers, service providers, and executive management * QA approver for major change controls , deviations and CAPAs; ensure timely investigation and/or
- implementation, review, approva and closure
- May directly manage 1 2 QA specialists with long term opportunity for expanded managing role
- 8 year s experience in a GMP regulated work environment (particularly Quality Assur ance) with solid understanding of EU regulations , aseptic filling experience preferred
- Bachelor or higher education level, major ed in bio pharmaceutical or related discipline (including
- bio technology, pharmacy, chemistry. etc)
- Ability to work as part of a high performing team and collaborate effectively with staff at all levels
- Results oriented and ability to deliver under pressure in a fast paced environment
- Skilled at assessing priorities and successfully managing workload with minimal supervision
- Solid oral and writing proficiency in English language , German language is a plus
- Demonstrated strong interpersonal, communication and leadership skills (wit h or without direct reports)
- Proven track record of contributions and professional growth and development in prior roles, including ability to apply judgment to areas outside of core competency
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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