Quality Manager (all genders) Batch Record Review – Biotechnological Products

Midas Pharma GmbH.; Frei-Weinheim; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A renowned family business, Midas Pharma GmbH, seeks a dedicated professional for batch record review and quality assurance in pharmaceutical manufacturing. This role demands excellent GMP knowledge and a strong sense of responsibility. The company offers an accommodating work environment, promoting creativity and professional development.

Leistungen

Personal and appreciative work atmosphere

Personal offices with ergonomic furniture

Opportunities for personal and professional development

Support programs and international assignments

Qualifikationen

• Experience in serialization desirable.
• Very good knowledge of German and English required; Korean advantageous.

Aufgaben

• Batch record review of biotechnological products.
• Monitoring of GMP-compliant documentation.
• Preparation of batch-specific review reports.

Kenntnisse

GMP knowledge

Communication skills

Quality-oriented approach

Ausbildung

Scientific training (PTA, BTA, CTA, etc.)

Jobbeschreibung

Your mission

• 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

Your profile

• 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

Our Offer

• 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