Manufacture QA Specialist

WuXi Biologics; Wuppertal; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

WuXi Biologics in Wuppertal, Germany seeks a Manufacture QA to oversee routine management of DS manufacturing and warehouse areas, ensuring GMP compliance and SOP adherence. The role requires 3+ years in pharma, a technical degree preferred, and strong English skills; German/Chinese a plus.

Responsibilities include monitoring, reviewing MBRs/BPRs, data review, change control, and assisting with inspections. Proficient in MS Office and a service-oriented mindset are essential.

Qualifikationen

• 3+ years of experience in the pharmaceutical industry.
• Bachelor’s degree in a technical discipline would be an advantage.
• Strong oral and writing English; German/Chinese a plus.
• Solid understanding of GMP and European regulations.
• Results oriented and able to deliver under pressure in a fast paced environment.
• Strong sense of service, decisiveness and responsibility; proficient in PowerPoint, Word, Excel.

Aufgaben

• Perform quality onsite-monitoring of the Drug Substance manufacturing process to ensure SOP and GMP compliance.
• Daily and routine monitoring of records, manufacturing area and processes for GMP and SOP compliance.
• Liaise with manufacturing operations, QA, QC, Engineering, MSAT to support daily operations.
• Review and approve MBRs and BPRs to ensure DS manufacturing aligns with technical transfer protocols.
• Review DI data before batch release and monitor abnormal situations during data review.
• Review and approve VMP, Process validation protocol, reports, and CPV.
• Participate in change controls and deviations; initiate CAPA where needed.
• Inspect and release DS manufacturing equipment and changeovers; ensure release.
• Support internal and external inspection readiness activities and corrective actions.
• Review SOPs related to DS manufacturing departments, and DS-related QRM.
• Review and approve QRM for warehouse and material management.
• Support shipping validations and perform other duties as assigned.

Kenntnisse

Quality Assurance

GMP knowledge

Regulatory compliance

English proficiency

MS Office

Communication skills

Ausbildung

Bachelor's degree

Jobbeschreibung

1. The Manufacture QA is a role within the German Quality organization and should be responsible for the routine management of DS manufacturing area and warehouse area in Wuppertal (MFG19) to ensure the compliance.

1. At least 3 years of relevant working experience in the pharmaceutical industry

2. A Bachelor’s degree in a technical discipline would be an advantage

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

• Perform quality onsite-monitoring of the whole Drug Substance manufacturing process to ensure all operations be executed as per SOP and GMP requirement for product quality
• Responsible for daily and routine monitoring to ensure record (including logbooks and BPRs etc.,), manufacturing area, process operations complied with GMP and SOP requirement
• Liaise with manufacturing operations, QA, QC, Engineering, MSAT etc. in supporting daily operations
• Responsible for reviewing and approval of MBRs and BPRs to ensure DS manufacturing process as per technical transfer protocols
• Responsible for DI reviewing before batch release and periodic e-data reviewing, including tracking and assessing any abnormal situation found during data reviewing
• Review the VMP, Process validation protocol, Report, New product introduce, Risk assessment, Technical transfer VMP, and CPV
• Participate in reviewing change control and deviations related to manufacture. ensure initiating Deviation timely; ensure initiating and closing minor Change Control; Responsible for checking of effectiveness for deviation CAPA
• Responsible for inspection and release of clearance and changeover in function rooms in DS manufacturing area; responsible for equipment release in DS manufacturing area
• Provide support for the preparation of internal and external inspection readiness activities. Follow up corrective action implementation
• Responsible for reviewing the SOP related to DS manufacture departments
• Responsible for reviewing and approve the QRM related to DS manufacture departments
• Responsible for printing and retrieving of BPRs
• Responsible for monitoring quality in warehouse area to ensure all operations be executed as per SOP and GMP requirement for product quality
• Responsible for daily and routine monitoring of warehouse area to ensure record (including logbooks etc.,) and operations as per regulations and internal requirements
• Responsible for reviewing weighing record to ensure weighing process and results as per manufacture and SOP requirement
• Responsible for equipment release in warehouse area. Assess and determine alarm in warehouse, follow up alarm handling process
• Responsible for receiving of transferring material among various sites to ensure internal material supply chain
• Responsible for decisions of abnormal and reject material in warehouse area, and monitor handling procedure
• Responsible for SAP operations of abnormal/reject material from manufacturing area
• Responsible for monitoring repackaging or distribution of product as per requirement
• Responsible for data confirmation and assessment of product return from manufacturing area or client
• Provide support for the preparation of internal and external inspection readiness activities. Follow up corrective action implementation
• Participate in reviewing change control and deviations related to warehouse. Control the progress to ensure initiating and closing quality events timely, and executing CAPA properly. Responsible for reviewing and approval of effectiveness check of deviation CAPA
• Responsible for reviewing the SOP related to warehouse and material management
• Responsible for reviewing and approve the QRM related to warehouse and material management
• Support the planning, execution, and documentation of shipping validations
• Perform additional duties at the request of direct supervisor