Manager Manufacturing

WuXi AppTec; München; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

Ein führendes Pharmaunternehmen in München sucht einen erfahrenen Manager Manufacturing, der die Herstellung und den Import von Arzneimitteln verwaltet. Der ideale Kandidat hat mindestens 3 Jahre Erfahrung in der pharmazeutischen Herstellung und Kenntnisse über GMP und GDP. Fließende Deutsch- und Englischkenntnisse sind erforderlich. Diese Rolle bietet die Möglichkeit, in einem dynamischen Umfeld mit Reisetätigkeiten zu arbeiten.

Qualifikationen

• Mindestens 3 Jahre praktische Erfahrung in der pharmazeutischen Herstellung.
• Gute Kenntnisse über GMP, GDP und nationale Gesetze.
• Erfahrung in der Auditierung externer Hersteller.

Aufgaben

• Verwaltung der Herstellung gemäß Paragraph 12 AMWHV.
• Sicherstellung der rechtzeitigen Überprüfung und Prüfung von Chargenunterlagen.
• Dokumentation und Genehmigung von Abweichungen im Verantwortungsbereich.

Kenntnisse

Pharmazeutische Herstellung

GMP-Kenntnisse

Organisationsfähigkeiten

Fließend Deutsch und Englisch

Führungsfähigkeiten

Ausbildung

Abschluss in Pharmazie oder Chemie

Tools

Microsoft Excel

Microsoft Word

Microsoft Outlook

Jobbeschreibung

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WuXi AppTec GmbH based in Munich is a certifying and importing site for commercial and investigational drug products for the EU market. In the frame of the expansion of our activity we are looking for a Manager Manufacturing who will be responsible for managing the manufacturing and import of medicinal products and investigational medicinal products in compliance with paragraph 12 AMWHV, GMP, and regulatory requirements. Ensures timely batch review, product testing, documentation, and release to the Qualified Person, while helping to maintain GMP-compliant facilities, partners/suppliers and optimized processes. Collaborates and actively works within Quality Assurance to manage deviations, CAPA, audits, and regulatory compliance. Occasional travel to external manufacturers, contract sites, or audit locations may be required.

Manufacturing Responsibilities

• Manage manufacturing in accordance with paragraph 12 AMWHV with a focus on the import of medicinal products and investigational medicinal products
• Ensure timely import and testing of batch records for products that comply with specifications
• Confirm review of batch records with date and signature to indicate that the batch was manufactured in accordance with approved manufacturing instructions
• Manufacture, import, test, and store medicinal products and investigational medicinal products in accordance with regulations and applicable marketing authorization or clinical trial authorization documents
• Check manufacturing records for accuracy and completeness and sign by suitable authorized persons before forwarding to the qualified person
• Make documents required for batch release (including import documentation for imported products) available to the qualified person in good time
• Maintain GMP-compliant qualification and requalification of all rooms, facilities, devices, and equipment for manufacturing, importing, packaging, storage, and shipping
• Ensure correct labeling and packaging in accordance with pharmaceutical law and provide valid package inserts or product information
• Validate manufacturing and packaging procedures and qualify relevant processes in accordance with valid SOPs
• Determine and monitor environmental conditions in all relevant areas (manufacturing, storage, packaging, shipping) and immediately address deviations
• Assist in selection, qualification, and monitoring of external manufacturers and import service providers (contract manufacturers, contract packagers, contract inspectors)
• Document, evaluate, and approve deviations in the area of responsibility in a timely manner and implement appropriate corrective and preventive actions (CAPA) on schedule

Quality Assurance Responsibilities

• Assist in testing, release, and release documentation of imported products
• Support compliance with GMP and GDP requirements
• Assist in processing of procedural instructions, deviations, CAPA measures, and change control processes
• Support audits and inspections and implement regulatory requirements
• Collaborate with the QA department to continuously optimize processes

Qualifications

• Degree in pharmacy, chemistry, chemical engineering, pharmaceutical technology, or a comparable field; alternatively, master craftsman's certificate and several years of professional experience as a technical employee, ideally in a technical management position
• Good knowledge and several years of practical experience in pharmaceutical manufacturing (minimum 3 years hands‑on experience) of solid, liquid, and sterile dosage forms, including relevant in‑process controls
• Good organizational and coordination skills as well as strong leadership and social skills
• Good knowledge of handling drugs and investigational medicinal products
• Good knowledge of GMP, GDP and national law
• Resilience and flexibility
• Fluent written and spoken German and English
• High level of customer and service orientation
• Proven track of auditing external manufacturers, contract sites, warehouses regarding EU‑GMP / GDP requirements
• Advantageous but not mandatory: Qualification as a qualified person in accordance with paragraph 14 AMG in conjunction with expertise in accordance with paragraph 15

Knowledge / Skills / Abilities

• Fluent written and spoken German and English
• In‑depth knowledge of GMP, GDP and national German law
• Strong documentation skills
• Self‑motivated and strong initiative skills
• Detail oriented and independently driven
• Strong troubleshooting and time management skills
• Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements

• Must be able to work in environment with minimal noise levels
• Clarity of vision
• Ability to identify and distinguish colors
• Ability to lift 25 lbs occasionally
• Ability to crouch, bend, twist and reach
• Inside working conditions

An Equal Opportunity Employer

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job‑related duties as requested by Management.