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Manager, Ext Manuf Quality Job

Date: Nov 19, 2017

Location: Shanghai, 31, CN

Company: MSD

Requisition ID: QUA006306

• Supplier Quality Assurance

The primary purpose of the position is to help ensure that all products or materials supplied to Merck Animal Health from a set of key suppliers are manufactured, packaged, analyzed and distributed in conformance to company and regulatory guidelines and meet both internal and external customer demands.

The incumbent is responsible for supporting total quality performance and operations of such Third Party Operations through direct support and technical advice, guidance, counselling to the site Quality Operations Manager or Director. The incumbent exercises a coaching role in guiding the Third Party to comply with Current Good Manufacturing Practices regulations and other pertinent legal requirements.

Responsibilities:
• Reports to the External Manufacturing Quality Lead - China (Animal Health) and is a member of the Quality External Manufacturing team primarily supporting third party activities in China. Receives guidance and direction when necessary but may also be required to operate independently. Keeps the Regional Quality Lead informed on the status of operations and when challenges, opportunities and/or issues arise.
• Assures that the partner operates within the agreed upon GMP policies and procedures (or other applicable regulations) and in accordance with the Quality elements of the Commercial Agreement and the Quality Agreement; ensures the Quality Agreements are kept up to date and ensures review of the Quality elements in the Commercial Agreement
• Acts as Merck-AH Quality Operations point of contact to defined key suppliers and as the Quality liaison between the external partner and the internal company personnel.
• Supports Merck Animal Health audit plans and effective execution of subsequent remediation by the partner; may also perform separate audits
• Conducts regular site visits to support training and coaching to initiate quality improvements within the partners’ Operations where necessary.
• Assures Quality requirements on Change Proposals submitted by the partners conform to all requirements.
• Reviews all Deviation investigations submitted by the partners and supports further investigation where necessary.
• Support Product Quality Complaint (PQC) investigations with the relevant suppliers
• Support Technology Transfer projects for the relevant suppliers
• Assures guidance is provided to the partner in the preparation of Quality Systems, procedures and guidelines as applicable
• Support effective preparations at the third party for regulatory inspections (where required).
• Effectively contributes to cross-functional investigations and project teams.
• Reviews batch documentation and data to support batch release activities when appropriate
• Maintains Quality metrics as required
• Completes additional Quality related activities as required to fulfil the role
Qualifications

• Bachelor degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent)
• Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
• Must have both Chinese and English language capability
• Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management;
• Must have the ability to influence management of complex manufacturing operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
• Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs and regulatory issues
• Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organisational complexity and ambiguity
• Preferably to have Auditor training (example ISO 9001)


Leadership Behaviors
include
• Focus on Customers and Patients
• Make Rapid, Disciplined Decisions
• Act with Courage and Candor
• Build Talent
• Demonstrate Ethics and Integrity
• Drive Results
• Foster Collaboration


Job: Qual Assurce - 3rd Party Manuf
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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