Pharma Manufacturing Compliance Qa Investigator
Neuenburg, Switzerland
Job Description
\\n Quality Assurance Operations - Validation - drug product
Join the site of our customer, globally active biopharma multinational. This is a two years on-site assignment in a fast growing commercial plant located in the French speaking part of Switzerland.
As Lead Investigator you wil be accountable for conducting deviation investigations until conclusion in support with the Global Investigation Program. Scope of investigations relates to all types of manufacturing processes, such as bulk production, packaging operations, warehousing and supply, technical services.
You:
Your tasks:
gloor&lang AG
gloor&lang THE RIGHT CHOICE IN CONSULTATION FOR LIFE SCIENCE TALENTS\\n \\n \\n \\n \\n \\n
Join the site of our customer, globally active biopharma multinational. This is a two years on-site assignment in a fast growing commercial plant located in the French speaking part of Switzerland.
As Lead Investigator you wil be accountable for conducting deviation investigations until conclusion in support with the Global Investigation Program. Scope of investigations relates to all types of manufacturing processes, such as bulk production, packaging operations, warehousing and supply, technical services.
You:
- BS/MS in Engineering/Technical discipline or equivalent experience
- Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP
Your tasks:
- Facilitate triage of deviations in order to assist deviation owners to define need for investigations
- Support initial impact/risk assessment for all deviations in conjunction with Quality Operations.
- Lead and conduct investigations until conclusion and ensures that the investigation outcome, root cause analysis and execution of corrective and preventive actions are completed in a timely, effective and compliance manner. Investigation scope may be related to bulk operations, packaging operations, warehouse, or maintenance processes.
- Partner with quality assurance and impacted departments (production, quality control, warehouse, maintenance, etc) to ensure investigations are exhaustive.
- Provide appropriate level of reporting and communication on the assigned investigations, at site and global levels (Investigation Review Board, pharma MS&T reporting)
gloor&lang AG
gloor&lang THE RIGHT CHOICE IN CONSULTATION FOR LIFE SCIENCE TALENTS\\n \\n \\n \\n \\n \\n
\\n\\n Gloor & Lang\\n \\n\\n
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Job Detail
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Job IdJD1631626
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationNeuenburg, Switzerland
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EducationNot mentioned