Quality Inspection Supervisor

招聘人数：若干 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 PURPOSE OF JOB
The post holder will provide leadership to prepare inspection plans and instructions, Co-ordinate inspectors team to perform pre-shipment inspections; Assist in complaint investigations and new product development.


The auditing function and be responsible, in conjunction with the quality team, for ensuring that medical products are manufactured, tested and released in compliance with cGMPs, US FDA and other applicable regulations.


KEY RESPONSIBILITIES


? Co-ordinate the inspection schedule to inspect the specified product(s) at specified vendors
? Co-ordinate the inspector team to execute the inspections of McKesson Shanghai Trading Co. Ltd. facilities by external parties if required
? Audit and review manufacturing facilities and third party service providers on a regular basis, to ensure compliance with cGMP, ICH and US FDA regulations and other relevant guidelines
? Supervise the document results of each inspection in a clear, concise and readable manner following the documentation instructions detailed in product specification and Quality procedural documents
? Interact with Vendors in a polite and established business-like manner, particularly during discussions regarding quality issues. For issues that cannot be resolved between the Inspector and Vendor in this manner, the Inspector must report / escalate the situation to the QA Manager
? Supervise all travel arrangements of the team necessary to get to and from each factory for scheduled inspections
? Monitor released documents and identifies errors or omissions for correction
? Assist in new product developing projects
? Assist in complaint investigating
? Assist in ensuring McKesson Shanghai Trading Co. Ltd. compliance policies and documentation are managed correctly and efficiently and provide recommendations and direction to relevant parties as necessary.
? Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required and cross train to facilitate this




ADDITIONAL RESPONSIBILITIES AND DUTIES
(The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned, as required, by management. When in conflict with the job description, the Staffing Request and Job Posting supersede the job description).



REQUIREMENTS
Education/Training:
? Bachlor’s Degree or additional in Science or Engineering discipline.
Experience:
? 5+ years Medical/Pharmaceutical experience in a similar type role within a progressive multinational organization.


Knowledge and Skills:


? Proven external auditing experience is essential.
? Solid understanding and knowledge of cGMP, quality Assurance and regulatory principles in a Medical Device manufacturing environment.
? Ability to lead the team to work effectively to accomplish goals in a challenging environment.
? Excellent communication skills with ability to communicate at all levels within the organization.
? Demonstrate ability to lead others to improve performance or effectiveness.
? Ability to work independently and make decisions based on judgement and integrity.
? Proven analytical skills and ability to transfer findings into report format.
? Excellent organisational and time management skills.
? Willing to travel




Competencies:
? Ability to communicate in English in written; and proficiency in oral a plus.


PC/Equipment:
? MS Office
Work Environment/Physical Demands:


General office environment.

On site visits to manufacturing facilities and laboratories.