Manufacture QA Specialist

WuXi Biologics; Wuppertal; On-site; EUR 60,000 - 85,000; Full time

Job summary

WuXi Biologics in Wuppertal is seeking a Manufacturing QA to oversee the DS manufacturing and warehouse areas, ensuring compliance with SOPs and GMP. You will monitor records, coordinate with QA/QC/Engineering, and review critical batch documentation to support product quality.

The role demands at least 3 years in pharma, a technical degree, and strong English skills; German and Chinese language abilities are advantageous. On-site work with cross-functional collaboration is required.

Qualifications

• At least 3 years of relevant working experience in the pharmaceutical industry.
• Bachelor’s degree in a technical discipline would be an advantage.
• Strong oral and writing English (Chinese and German is a plus).
• Solid understanding of GMP and European regulations (German drug law is a plus).
• Results oriented and ability to deliver under pressure in a fast paced environment.
• Think individually with a strong sense of service, decisiveness and responsibility. Good knowledge of Microsoft Office – Powerpoint, Word, Excel.

Responsibilities

• Perform quality onsite-monitoring of the whole Drug Substance manufacturing process to ensure all operations are executed per SOP and GMP.
• Responsible for daily monitoring to ensure records and manufacturing area comply with GMP and SOP.
• Liaise with manufacturing operations, QA, QC, Engineering, MSAT in supporting daily operations.
• Review and approve MBRs and BPRs to ensure DS manufacturing per transfer protocols.
• Review DI before batch release and data reviews including abnormal situations.
• Review VMP, validation protocols, reports, new product introductions, risk assessments, CPV.
• Participate in reviewing change control and deviations related to manufacture; initiate deviations timely and manage CAPA.
• Inspect and release clearance and changeovers in DS manufacturing area; release equipment in DS area.
• Support inspection readiness activities and follow up corrective actions.
• Review SOPs related to DS manufacture departments and QA.
• Review and approve QRM related to DS manufacture departments.
• Print and retrieve BPRs; monitor warehouse quality to SOP and GMP compliance.
• Monitor warehouse operations; verify logs, records, and procedures per regulations.
• Review weighing records to ensure accuracy; manage warehouse material releases and alarms.
• Manage SAP operations for abnormal/reject material and monitor repackaging or distribution as required.
• Confirm data and assess product returns; support shipping validation planning.
• Additional duties as requested by supervisor.

Skills

GMP knowledge

English fluency

SOP adherence

MS Office

Quality assurance

Education

Bachelor’s degree in a technical discipline

Tools

PowerPoint

Word

Excel

Job description

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