QA for Drug Substance and Warehouse

QA for Drug Substance and Warehouse

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

The QA for Drug Substance and Warehouse sits within the German Quality organization and will be responsible for the routine management of DS manufacturing area and warehouse area in Wuppertal (MFG19) to ensure the compliance.

Department Description

As QA for DS and WH, you will be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the QA Ops Team Lead.  

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

• 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 introduction, 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 quality.
• 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.

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

 Bildungshintergrund und Erfahrung / Education Background and Experience

Qualifications/Experience:

• At least 3 years of relevant working experience in the pharmaceutical industry
• A 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

Besondere Kenntnisse / Special Knowledge

• Good organizational skills.
• Good interpersonal communication skills.
• Excellent oral & written communication skills (English; German is preferable).

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WuXi Biologics is an equal opportunities employer.