Specialist - Quality assurance/management (m/f/d)
vor 1 Woche
We are currently looking for a motivated Batch Record Review Specialist for a business partner in Mannheim . A secure and fair salary and good social benefits are just as important to you as a responsible job and a long-term perspective in the pharmaceutical sector ? Then join us - your satisfaction is our goal Apply directly online now We value equal opportunities and welcome applications from people with disabilities, whose inclusion is particularly important to us.
Here's what we offer
Attractive salary and long-term job security through group affiliation Extensive social benefits, including Christmas and vacation bonuses Up to 30 days' vacation per year Contribution to company pension scheme after end of probationary period A wide range of employee benefits
Your tasks
Quality assurance: checking and securing production documentation in accordance with GMP guidelines, including corrective measures. Deadline management: Ensuring compliance with delivery deadlines and checking manufacturing documents for completeness. GMP compliance: Support with GMP audits and collaboration in deviation analyses and crisis management. Document management: Archive searches for inspections and quality assessments; maintenance of document versions and release data. Process optimization: development and updating of standard operating procedures (SOPs), initiation of training courses and management of quality projects. Data analysis: Evaluation of production data and creation of trend analyses for continuous improvement. System support: processing reports from production and implementing batch recording systems. Coordination: Coordination of the documentation process with the planning department and provision of necessary materials for production areas.
Your profile
Degree in biotechnology, pharmacy, chemical engineering or comparable qualification with relevant professional experience Experience in the manufacture of parenterals and knowledge of batch documentation In-depth knowledge of GMP, in particular documentation and hygiene standards in the pharmaceutical industry Confident handling of MES, SAP and MS Office, especially Excel and Word Strong communication skills, ability to work in a team, organizational skills and initiative Fluent German and good written and spoken English-
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