长沙招聘

Department: GMP QA
Group: QA Validation
Function: Equipment Validation Expert
Position: Group Leader to Assistant Director

Key accountabilities:
1、 Validation, calibration and maintenance management:
？ Develop and update of the Validation Master Plan (VMP) and follow up.
？ Review validation files：Equipment & Utility qualification, focused on manufacturing equipment.
？ Follow up the calibration plan and review the calibration documents.
？ Follow up the maintenance plan and review the preventive maintenance documents.
？ Define validation, calibration and maintenance strategy, the necessary actions, the responsibilities and the documentation required in the validation procedure. Ensure validation compliance to cGMP, industry standards and regulatory expectations.
？ Organize the execution of preventive maintenance, calibration, and periodic review and requalification activities and communicate this with the related departments.
2、 Change Control management:
？ Monthly monitoring of the progress of raised changes and follow up with action plans.
？ Able to write change controls, deviations and CAPAs in a logical and clear manner, and review these documents.
3、 Yearly trend analysis of environmental monitoring results for the purified water system, nitrogen system, HVAC, compressed air system and production equipment.
4、 Review of current equipment validation practices and propose changes to improve these practices, i.e. align them with US and EU standards.
5、 Fulfill a consultant role in the field of equipment validation for QA and the production department.

The candidate must have the following technical qualifications:
1、 Bachelor degree, but preferably a Master degree, in one of the following fields of engineering: Mechanical engineering; chemical engineering; process engineering; pharmaceutical engineering
2、 At least 6 years of working experience in a GMP environment (i.e. have an excellent working knowledge in US, EU, China GMP)
3、 At least 4 years of equipment validation experience for a foreign multinational in China
4、 A working knowledge of industry standards related to validation in general and production equipment in the pharmaceutical industry, e.g. ASME BPE, in particular
5、 Extensive experience with the execution of initial equipment validations (URS, DQ, IQ, OQ, PQ) and reviewing of URS and qualification protocols (before and after execution).
6、 Extensive experience with writing validation reports
7、 Extensive experience with maintaining the validated state of equipment in operation

Other skills:
1、 Language skills: Proficient in Chinese and English (especially written English)
2、 Computer skills: MS Office software (Word, Excel, PowerPoint, Visio)
3、 Show leadership within inner-department to coordinate, collaborate, instruct and lead to complete validation management work
4、 Writing skills: Needs to be able to formulate thoughts on paper in a clear and logical manner
5、 Motivated to learn, to apply, and to summarize through continual improvement
6、 Have a good understanding of pharmaceutical production equipment: including but not limited to Fluid Bed Granulator Coater, Blister Packaging Machine, Automated Capsule Filling Machine

Having the following is a plus:
1、 Experience with oral solid dosage, particularly with its manufacturing process
2、 Experience with non-sterile manufacturing
3、 QA background

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