QA OPS Lead

WuXi Biologics; Wuppertal; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

WuXi Biologics in Wuppertal seeks a Manufacturing QA Lead to ensure GMP compliance across manufacturing, warehousing and material management activities. You will lead the on-the-floor QA team, provide technical oversight across MSAT and related processes, and drive quality decisions in a fast-paced environment.

The role requires 8+ years in pharma with 5+ in quality, strong English, and familiarity with GMP/validation concepts. German language is a plus and MS Office proficiency is essential.

Qualifikationen

• Minimum 8 years in pharmaceutical industry with at least 5 years in a Quality role.
• Strong knowledge of GMP and European regulations (German drug law is a plus).
• Excellent oral & written English; German/Chinese is a plus.
• Knowledge of Validation principles and Computerized System Validation/ Cleaning/ Process Validation preferred.

Aufgaben

• Lead Manufacture QA team for on-the-floor support.
• Provide oversight, technical expertise across Manufacturing, Warehouse, MSAT and related QA functions.
• Establish the team and manage 3–4 direct reports including training and prioritization of work.
• Make Quality decisions during manufacturing in compliance with internal procedures.
• Support site QMS; participate in SOP revision and training material preparation.
• Review and approve Change Control/Deviation/CAPA systems and drive closure of records.
• Manage batch record review and train QA specialists; coordinate with QA for batch certification.
• Act as a role model for team, uphold WuXi core values and local requirements.
• Perform other quality-related duties as assigned by supervisor.

Kenntnisse

Leadership

Organizational skills

Interpersonal communication

Verbal & written communication

Team player & stakeholder mgmt

Tools

Microsoft Office (PowerPoint)

Microsoft Word

Microsoft 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.