Your tasks and responsibilities
1) Quality oversight of 3rd manufacturing for pharmaceutical products, health food, cosmetic and food etc. such as
- Ensure QAA available and updated
- Review and approve change, deviation, OOS report etc.
- PTC investigation review
- Material Supplier management if applicable
- Take part in the surveillance GMP audit and CAPA follow up etc.
- Implement new regulation/requirements for 3rd manufacturing products
2) Product release if applicable
3) Quality management for innovation projects, such as
- Participate due diligence investigation
- perform GMP audit,
- CAPAs follow up,
- Change management
- Quality review
- Prepare the document for internal approval
- Ensure quality assurance agreements availability for new product
4) Support to product license renew and product relevant requirement
5) Maintain relevant quality management procedures for 3rd manufacturing management based on local regulation and Bayer internal requirements.
6) 3rd party manufacturing organization quality system improvement in case needed.
Who you are
- Bachelor degree or above with food science, pharmacy or relevant subjects
- Minimum 6 years technical experience in quality / technical positions in quality assurance (dosage form)
- At least 3 years quality management experience in pharmaceutical industry or dietary supplement, food ets. areas.
- Familiar with local regulation/requirements related to manufacturing of Pharmaceutical products or health food/ food etc.
- With strong ability for problem solving and ability of organization and coordination.
- With strong communication and interpersonal skill.
- Preferably have medium to high level English skill.
- International GMP experience is preferred.
Functional Area: [sap_fa_20]
Entry Level: 5