Manufacture QA Specialist

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

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.

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

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

Besondere Kenntnisse / Special Knowledge

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

1. 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
2. Responsible for daily and routine monitoring to ensure record (including logbooks and BPRs etc.,), manufacturing area, process operations complied with GMP and SOP requirement
3. Liaise with manufacturing operations, QA, QC, Engineering, MSAT etc. in supporting daily operations
4. Responsible for reviewing and approval of MBRs and BPRs to ensure DS manufacturing process as per technical transfer protocols
5. Responsible for DI reviewing before batch release and periodic e-data reviewing, including tracking and assessing any abnormal situation found during data reviewing
6. Review the VMP, Process validation protocol, Report, New product introduce, Risk assessment, Technical transfer VMP, and CPV
7. 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
8. Responsible for inspection and release of clearance and changeover in function rooms in DS manufacturing area; responsible for equipment release in DS manufacturing area
9. Provide support for the preparation of internal and external inspection readiness activities. Follow up corrective action implementation
10. Responsible for reviewing the SOP related to DS manufacture departments
11. Responsible for reviewing and approve the QRM related to DS manufacture departments
12. Responsible for printing and retrieving of BPRs
13. Responsible for monitoring quality in warehouse area to ensure all operations be executed as per SOP and GMP requirement for product quality
14. Responsible for daily and routine monitoring of warehouse area to ensure record (including logbooks etc.,) and operations as per regulations and internal requirements
15. Responsible for reviewing weighing record to ensure weighing process and results as per manufacture and SOP requirement
16. Responsible for equipment release in warehouse area. Assess and determine alarm in warehouse, follow up alarm handling process
17. Responsible for receiving of transferring material among various sites to ensure internal material supply chain
18. Responsible for decisions of abnormal and reject material in warehouse area, and monitor handling procedure
19. Responsible for SAP operations of abnormal/reject material from manufacturing area
20. Responsible for monitoring repackaging or distribution of product as per requirement
21. Responsible for data confirmation and assessment of product return from manufacturing area or client
22. Provide support for the preparation of internal and external inspection readiness activities. Follow up corrective action implementation
23. 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
24. Responsible for reviewing the SOP related to warehouse and material management
25. Responsible for reviewing and approve the QRM related to warehouse and material management
26. Support the planning, execution, and documentation of shipping validations
27. Perform additional duties at the request of direct supervisor