Senior QA Specialist job in Munich, Germany

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Good Clinical Practice (GCP)

Location: Germany

This vacancy has now expired. Please see similar roles below...

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.

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