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 the 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.

The position can be filled out remotely site Munich does not physical GMP manufacturing activity yet certain activities need to be performed on site on an occasional basis.  

Experience / Education

• 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 (3years minimum 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 and GDP and national law
• Resilience and flexibility
• Fluent written and spoken German and English
• High level of customer and service orientation
• Proven track of history 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 (1)

Knowledge / Skills / Abilities:

• Fluent written and spoken German and English
• In-depth knowledge of GMP, GDP and national german law
• Strong documentation skills
• Proven to be self-motivated and has strong initiative skills
• Detail oriented and independently driven
• Demonstrated 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. 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.

Purpose of the position

• Management of manufacturing in accordance with paragraph 12 AMWHV with a focus on the import of medicinal products and investigational medicinal products
• Ensuring the timely import and testing of batch records for products that comply with specifications
  • Active participation in the quality system, including the creation and revision of procedural instructions, forms, and lists
• The tasks as the head of manufacturing include in particular:
  • Confirming the review of batch records with the date and signature to indicate that the batch was manufactured in accordance with the approved manufacturing instructions
  • Ensuring that medicinal products and investigational medicinal products are manufactured, imported, tested, and stored in accordance with regulations and the applicable marketing authorization or, in the case of investigational medicinal products, in accordance with the clinical trial authorization documents
  • Ensuring that manufacturing records are checked for accuracy and completeness and signed by suitable, authorized persons before being forwarded to the qualified person
  • Ensuring that all documents required for batch release (including import documentation for imported products) are made available to the qualified person in good time
  • Ensuring GMP-compliant maintenance, qualification, and re-qualification of all rooms, facilities, devices, and equipment for manufacturing, importing, packaging, storage, and, if applicable, shipping
  • Ensuring that products are correctly labeled and packaged in accordance with pharmaceutical law and provided with valid package inserts or product information
  • Ensuring the proper validation of manufacturing and packaging procedures and the qualification of relevant processes in accordance with valid SOPs
  • Determining and monitoring environmental conditions in all relevant areas (manufacturing, storage, packaging, shipping) and immediately addressing any deviations
  • Assisting in the selection, qualification, and monitoring of external manufacturers and import service providers (contract manufacturers, contract packagers, contract inspectors)
  • Ensuring that all deviations in the area of responsibility are documented, evaluated, and approved in a timely manner and that appropriate corrective and preventive actions (CAPA) are implemented on schedule
• Tasks in the area of quality assurance include in particular:
  • Assisting in the testing, release, and release documentation of imported products
  • Supporting the assurance of compliance with GMP and GDP requirements
  • Assisting in the processing of procedural instructions, deviations, CAPA measures, and change control processes
  • Supporting audits and inspections as well as the implementation of regulatory requirements
  • Collaborating and working within with the QA department to continuously optimize processes