Manufacture QA Lead

WuXi Biologics; Wuppertal; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

WuXi Biologics in Wuppertal (MFG19) seeks a Manufacturing QA Lead to ensure GMP-compliant manufacturing, material management and warehousing operations. You will lead a QA team on the floor, provide technical oversight across manufacturing, MSAT and warehouse activities, and drive changes through the QMS.

The role requires leadership skills, long experience in pharma QA, and strong communication in English. German language is a plus.

Qualifikationen

• 8+ years in pharma, with 5+ years in quality.
• Knowledge of Validation principles; CSV/ Cleaning/ Process Validation preferred.
• Strong oral and written English; German/Chinese a plus.
• Solid GMP and European regulations understanding.
• Results oriented with ability to deliver under pressure.
• Service mindset with responsibility; proficient in MS Office.

Aufgaben

• Lead Manufacture QA team for on-the-floor support
• Provide oversight, technical expertise and leadership across product manufacturing through Warehouse, Manufacturing, MSAT, and related support
• Establish the team and manage 3-4 direct reports and their day-to-day activities, provide training and prioritization
• Make Quality decisions during manufacturing in compliance with internal procedures
• Support site-based QMS; participate in revision/approval of SOPs and training materials
• Review and approve Change Control/Deviation/CAPA systems; drive records to closure
• Manage batch record review; train QA specialists; work with QP for batch certification
• Act as a role model for the team; adhere to WuXi core values and local requirements
• Perform other quality-related duties as assigned by supervisor

Kenntnisse

Leadership

Organizational skills

Interpersonal communication

English proficiency

MS Office

Stakeholder management

Tools

PowerPoint

Word

Excel

Jobbeschreibung

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

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

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

• Lead Manufacture QA team for on-the-floor support
• Provide oversight, technical expertise and leadership across all aspects of product manufacturing through Warehouse activities, Manufacturing, MSAT, and other production related support
• Establish the team and manage 3-4 direct reports and their day-to-day activities, provide training and communications, assignment and prioritization of work.
• Make Quality decisions during manufacturing in compliance with internal procedures.
• 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.
• Review and approve Change Control/Deviation/CAPA systems. Drive records to closure.
• Manage the batch record review process and train QA specialists on Manufacture QA responsibilities. Work closely with responsible QP for batch certification.
• Act as a role model for your team member and within German Quality in adherence to the WuXi corporate core values and local requirements.
• Perform other quality-related duties and responsibilities as assigned by the supervisor.