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QC (Senior) Engineer

Your role:

Overall Objectives of the Position

1.    Make sure the QC Lab compliance to meet the FDA, EMA, ISO9001:2015 and other related regulation requirement, and meet Customer expectation.

2.    To Leading the QC projects and continues to improve the QC technologies and efficiency.

Main Tasks

1.    Leading the methods transfer, and test method validation for CCM, RTU and PIS products.

2.    Maintain the high GMP compliance and DI for QC lab.

3.    Leading the QC compliance to meet the FDA, EMA and ISO9001:2015 related regulation requirement, meet the Regulatory and Customer expectation.

4.    Contribute to problem solving associated with laboratory work such as OOE/OOS/DEV/QE investigation.

5.    Manage audit schedule and participate in product and QC audits as required, including regulation, customer and supplier surveillance audits.

6.    Assist in developing, implementing and participating in continuous improvement efforts through process and data analysis.

7.    Implement problem solving and quality concern resolution (RCA,5-whys; Cause/effect diagrams, etc.).

8.    Coordinate and/or conduct training of quality awareness, QMS requirements, customer requirements and procedures in QC area.

9.    Develop and implement LIMS and other IT systems needed in compliance with the Quality Management System.

10.   Strictly comply with company EHS safety regulations and master skill of safety work and emergency rescue knowledge.

11.   Play as a coach role to train new employees.

12.   Take responsibilities in assigned projects as appropriate.

13.   Be a valuable team member of Quality organization and develop self and others (e.g. junior lab staff/new comer training) through close teamwork and cross functional/sectional activities. Be a continuous improver.

 

Who you are:

1.    Education:Bachelor or above. (Chemistry, Pharmaceutical, food etc.)

2.    Working Experience:

(1)Attainment of qualified/responsible person status under local/international legislative requirements.

(2)Local language, Basic English speaking, good English reading and understanding

(3)At least 5 years of tests and methods validation experiences in QC physical and chemical lab (experience in microbiological lab will add value). SAP and LIMS experience will add value.

(4)Have the strong OE knowledge in QC Lab.

(5)Cross-functional working environment.

(6)Team working.

3.    Technical & Professional Knowledge:

(1)Skilful in using office application software (MS-Word, MS-Excel, MS-Outlook)

(2)Be able to work independently. Perform the analysis work within cGMP environment and minimize laboratory errors.

 

HR: 87157 

Functional Area: Quality 

 

Job Requisition ID:  208028
Location:  Nantong
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

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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