DSM – Bright Science. Brighter Living.™

Royal DSM is a purpose-led global science-based company in Nutrition, Health and Sustainable Living. DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative business solutions for human nutrition, animal nutrition, personal care and aroma, medical devices, green products and applications, and new mobility and connectivity. DSM and its associated companies deliver annual net sales of about €10 billion with approximately 23,000 employees. The company is listed on Euronext Amsterdam. More information can be found at www.dsm.com .

Job Title: QA Validation/Compliance Officer

Report to: QA Manager

Business Unit: DNP/Operations/M&T

Location: Fengxian, Shanghai

• The QA Validation/Compliance Officer supports local plant operations (i.e.: validation management, client audit, deviation/OOS management and MOC) to ensure Quality System requirements (cGMP, ICH Q7, QS, FAMI-QS, etc.) are maintained throughout the local value chain.
• They educate and coach operations personnel on the criticality of GMP activities, ensure that site procedures are enforced and give guidance to local management of best practices.
• Adaptable to rapid change and moving targets in terms of continuously evolving GMP compliance requirements/standard, client expectation, product quality standards and organizational changes.
• Cross communication with external and internal to solve the confliction which cause by high expectation from client/compliance.
  

The Position:

SHE and security responsibility

• Knowing requirements.
• Active participation all SHE and security trainings to gain knowledge and improve awareness.
• Following the SHE/security requirements and report if not clear.
• Report accident/incident/near miss timely/ unsecure situations and security incidents.
• Execute SHE/occupational health procedure/emergency evacuation procedure of company.
• Wear PPE as requirements.
  

Participate, support and/or conduct

• Client audit preparation and CAPAs’ follow up;
• Validation management: work with related department to make sure the validation works been completed properly;
• Daily operation of Deviation/OOS management and MOC for assigned products, and CAPAs’ follow up;
• Customer complaint investigations;
• Related quality license renew;
• Deviation reports & NCR investigation reports and root cause analysis;
• Document control centre (DCC) work;
• Give training to shop floor staff (i.e. GMP, SOP etc.);
• Certification and statement preparation of (i.e. Allergen, Residual Solvents etc.);
• Work with global RA team for registration dossiers’ preparation and reviewing;
• Participate operational team meetings in support of operations;
• Product stability testing programs;
• HACCP study report review;
• Annual product quality review.
  

The Ideal:

• Bachelor level in Sciences (majored in chemicals or pharmaceuticals) at least.
• Specialization in GMP and QA
• At least 3 years experiences in QA of API industry, involvement in in GMP, GDP, DI, CAPA, RCA and so on.
• Familiar with client audit and Validation & Qualification
• Familiar with Root cause analysis for deviation and OOS management
• Experienced in Quality Risk Management
• Knowledge of chemical process and pharmaceutical registration are preferred
• Good communication and social skills
• Fluent in English (written and oral)
  

The Reward:

We offer you a rewarding and challenging job with lots of opportunities for personal growth and career development in a professional, entrepreneurial, no-nonsense and very agile environment. We strive to be an Employer of Choice and ensure that our employees are nurtured and given the opportunity to develop their talents. Terms and conditions as well as fringe benefits and salary are in line with market standards.

Procedure & Contact:

Interested in this position? Please apply on-line by sending us your CV & Motivation letter in English via the career portal ( www.dsm.com/careers ). For additional questions, pl ease contact Mandy.tao@dsm.com

Royal DSM is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as a qualified individual with a disability, or any other characteristic protected by law.