QC (Senior) Engineer

Posted 06 Jul 2020

Nantong, Jiangsu - China

Req Id 208028

Details

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


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 

 


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

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