Quality Manager (m/w/d) Batch Record Review Biotechnological Products

Company : Midas Pharma Gmbh

Job Type : Full Time

Ingelheim

Job Description - Quality Manager (m/w/d) Batch Record Review Biotechnological Products

Batch record review of manufacturing and testing protocols of biotechnologically produced active ingredients and finished dosage forms
Responsible monitoring of GMP-compliant documentation for completeness, plausibility and correctness.
Administration and GMP-compliant filing of manufacturing and test documents in our Document Management System (d.velop)
Evaluation of quality key figures
Preparation of batch-specific batch record review reports
Participation in audits and self-inspections at contract manufacturers and contract laboratories
Communication with internal and external stakeholders as well as business partners

Successfully completed scientific training (e.g. PTA, BTA, CTA, etc.) or successfully completed scientific studies
Very good GMP knowledge and knowledge of pharmaceutical documentation requirements
Experience in the field of serialization desirable
Good communication skills and the ability to formulate precisely and concretely
Interest in reviewing documents and identifying any discrepancies
Strong sense of responsibility and quality-oriented approach
Very good knowledge of German and English is mandatory, Korean language skills are advantageous

Midas Pharma is a well-established and renowned family business that offers you a personal and appreciative working atmosphere in addition to the security of over 30 years of business
Our workplaces are not open-plan offices, but personal offices where you can also retreat from time to time, equipped with the latest technology and ergonomic office furniture
Our organization enables you to make quick decisions - a key factor of our success
Due to our flat hierarchies, there is a very close interaction at Midas - personal and professional - it is not uncommon for management to be involved in interdisciplinary projects
We are looking for you as a personality and want you to contribute authentically - in turn, we encourage this by giving you great freedom for creativity and independence
At Midas, all paths to personal and professional development are open to you - various support programs as well as assignments abroad are just a few possibilities

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Quality Manager (m/w/d) Batch Record Review Biotechnological Products

Job Description - Quality Manager (m/w/d) Batch Record Review Biotechnological Products

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