Manufacture QA Lead

Teil II Primäres Ziel der Stelle / Part II Primary Job Objective

The Manufacture QA Lead is a key role within the German QA organization to ensure manufacturing material management and warehousing operations at Wuppertal site (MFG19) are GMP compliant and follow internal procedures and processes

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

1. At least 8 years of relevant working experience in the pharmaceutical industry with at least 5 years spent in a Quality role.

2. Working knowledge of Validation principles and knowledge of Computerized System Validation/ Cleaning/ Process Validation is preferred

3. Strong oral and writing English (Chinese and German is a plus)

4. Solid understanding of GMP and European regulations (German drug law is a plus)

5. Results oriented and ability to deliver under pressure in a fast paced environment

6. Think individually with a strong sense of service decisiveness and responsibility. Good knowledge of Microsoft Office Powerpoint Word Excel

Besondere Kenntnisse / Special Knowledge

1. Very good leadership skills

2. Good organizational skills

3. Good interpersonal communication skills

4. Excellent oral & written communication skills (English; German is preferable)

5. Task-oriented team player with partnering and stakeholder management skills

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

1. Lead Manufacture QA team for on-the-floor support

1. Provide oversight technical expertise and leadership across all aspects of product manufacturing through Warehouse activities Manufacturing MSAT and other production related support

1. Establish the team and manage 3-4 direct reports and their day-to-day activities provide training and communications assignment and prioritization of work.

1. Make Quality decisions during manufacturing in compliance with internal procedures.

1. Support site based quality management system (QMS). Participate in revision and approval of SOPs including Training Assessment evaluation and preparation of quiz material for training.

1. Review and approve Change Control/Deviation/CAPA systems. Drive records to closure.

1. Manage the batch record review process and train QA specialists on Manufacture QA responsibilities. Work closely with responsible QP for batch certification.

1. Act as a role model for your team member and within German Quality in adherence to the WuXi corporate core values and local requirements.

1. Perform other quality-related duties and responsibilities as assigned by the supervisor.