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

Midas Pharma GmbH.; Frei-Weinheim; Vor Ort; EUR 50.000 - 65.000; Vollzeit

Zusammenfassung

A reputable pharmaceutical company in Rheinland-Pfalz is seeking a candidate for a position focused on GMP compliance and documentation oversight. Responsibilities include batch record reviews, stakeholder communication, and participation in audits. The ideal candidate has completed scientific training and possesses strong GMP knowledge in both German and English. This role offers flexible hours and 30 days of vacation.

Leistungen

Flexible working hours

30 days vacation

Comprehensive training opportunities

Employee restaurant

Regular events

Qualifikationen

• Successfully completed scientific training or studies.
• Very good GMP knowledge and pharmaceutical documentation requirements.
• Experience in serialization is desirable.
• Very good knowledge of German and English is mandatory.

Aufgaben

• Batch record review of manufacturing and testing protocols.
• Monitoring GMP-compliant documentation for completeness.
• Administration and GMP filing in Document Management System.
• Evaluation of quality key figures.
• Preparation of batch-specific review reports.
• Participation in audits and self-inspections.
• Communication with stakeholders and business partners.

Kenntnisse

GMP knowledge

Communication skills

Attention to detail

Ausbildung

Scientific training (e.g. PTA, BTA, CTA)

Jobbeschreibung

Your mission

The position is initially limited to three years as a parental leave cover.

• 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
• 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

• A job in an established and renowned family business that offers you the security of over 35 years in business as well as a personal and appreciative working atmosphere
• Flexible working hours and 30 days' vacation
• Comprehensive training opportunities with a fixed annual training budget
• A modern working environment
• Various benefits such as JobRad, EGYM Wellpass, employee restaurant, regular events and much more.
• We have flat hierarchies and small teams without matrix structures. This enables us to have clear and direct communication channels that lead to fast decision-making processes
• We are looking for you as a personality and want you to make an authentic contribution - we encourage this in turn by giving you plenty of scope for creativity and independence