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Quality System Specialist

Your role

Expert of Computer System Validation (CSV) lifecycle at Nantong Site.

Provides life cycle management and coordination service for all aspects of computer system validation and regulatory compliance activities at Nantong Site.

Works to maintain and manage quality systems regarding GAMP and cGMP for the site.

Supports or performs internal and third-party audits and inspections to assure compliance with regulations.
Be the lead CSV Quality & Compliance specialist for the implementation and operation of cGMP Computerized at Nantong Site.

Provide quality and compliance support and expertise to Nantong projects and operations in support of a controlled environment and associated processes that meet the quality and compliance requirements of the site and the wider company.

Apply best practice processes and procedures to support the efficient and compliant operation of computerized systems of work.

Works in collaboration with Corporate IT, Site IT, Manufacturing, Technical, Engineering and Quality groups (QC and QA).

Has an excellent understanding of cGMP, GAMP and Annex 11, 21 CFR Part 11 keeps up to date with relevant regulations and legislation, evaluates the effect of new or changed law and practices on current operations and suggests modifications when necessary.

Analyses complex issues and processes and applies own professional knowledge to identify areas for improvement.

Reviews and approves cGMP or regulatory reports/ protocols/ submissions / deviation / change control and associated action plans. Provides guidance to others on their preparation.

Makes appropriate recommendations and successfully effects change.

Acts as a source of technical expertise for others and gives advice on own area to other functions and employees.

Perform internal Compliance audits on for all IT, Manufacturing, Labs, Warehouse and Applications.

Participate in auditing third parties.

Coordinates with related validation activities on site.

 

who you are:

A bachelor or above in a computer science, engineering or pharmaceutical related subject area.

Will normally have oITained further professional qualifications.

Proven ability to lead project teams or host quality audits.

Demonstrated knowledge of working successfully within a Quality Management System and cGMP.

Fully conversant with the requirements of cGMP, Annex 11, GAMP, 21CFR Part 11 as practiced in the pharmaceutical industry.

Will have worked on multiple GAMP related projects for multiple aspects of IT and/or process control systems and in various roles covering the full spectrum of activity – development of protocols; execution of validation; development of standards and operating procedures; providing expert advice on projects and in support of operational activity.

Has detailed up to date regulatory knowledge in the field of computer systems validation.

 

HR 95592

Functional area: Quality
 

Job Requisition ID:  191145
Location:  Nantong
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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