Senior QA Specialist
- Permanent
- Good Clinical Practice (GCP)
- Germany
An innovative pharmaceutical company is in search for a talented QA Specialist, this is a senior role and the selected candidate implement product monitoring, address product recall and product complaints.
Job Responsibilities
- 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
Skills and Requirements
- 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
To Apply
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
#LI-AM1
Related jobs
Highly Competitive Salary
Princeton, USA
Proclinical is currently recruiting for a Training & Documentation Specialist for an exciting and rapidly growing biopharmaceutical company in New Jersey.
Highly Competitive Salary
New York, USA
Proclinical is currently recruiting for a Senior GCP Quality Specialist with a global clinical testing service located remotely.
Highly Competitive Salary
New York, USA
Proclinical is currently recruiting for an Associate Director of GCP Audit Management for a leading pharmaceutical company located remotely in the east coast.
Highly Competitive Salary
North Chicago, USA
Proclinical is currently recruiting for a Product Compliant Analyst with a biopharmaceutical company located in North Chicago, IL.
Highly Competitive
Cascais, Portugal
The post holder will double down as the 'Responsible Person' managing the Portugal Region
Highly Competitive Salary
Morris Plains, USA
Proclinical is currently recruiting for an Manufacturing Specialist of Upstream with a leading biotechnology company located in Morris Plains, NJ.
Highly Competitive Salary
Rockville, USA
Proclinical is currently recruiting for a Senior QA Specialist for a busy, non-profit, biotechnology company located in Rockville, MD.
Highly Competitive Salary
Philadelphia, USA
Proclinical is currently recruiting for a Quality Labeling Specialist with a pharmaceutical company located in Philadelphia, PA.
Highly Competitive Salary
Wilmington, USA
Proclinical is currently recruiting for a Quality Labeling Specialist with a pharmaceutical company located in Wilmington, DE.
Highly Competitive Salary
Raritan, USA
Proclinical is currently recruiting for a QA Investigations Lead with a pharmaceutical company located in Raritan, NJ.