Senior Operational QA

Basic qualifications:

Specialized Knowledge 专业知识:

  • breadth & depth across disciplines or functions; expertise in field required

所需知识的宽度(跨学科),所需知识的深度 (特定学科)

ESSENTIAL

  • Education degree and speciality

Bachelor degree or above, major in pharmaceutics.

4 years or above, quality management experiences

Know GSK quality organization and QMS system.

Be familiar with GSK report system /evaluation system/CAP system/audit system.

Know relative state and regional law, such as GMP, MHRA.

Be familiar with all company quality standard, procedure and CP, USP, EP.

  • Computer and foreign language level

Fluently use OFFICE software .

Well English reading and speaking skill which is equivalent to CET-4.

  • Capability requirement

Good job morality, honest, careful, responsible.

High quality sensitivity.

Good comprehensively analytical ,communication, association, response and innovation ability.

Good learning skill.

General leading and organizing ability.

.

DESIRED

  • Good interpersonal skills.

Preferred qualifications:

N/A

Details:

Job Purpose 岗位目的:

1.Ensure the quality assurance of responsible product line, check and control the process according to GMP.

2.Coordinator for investigation of deviation, customer complaint, supplier complaint;

3.Work with Value Stream staff to improve on-line management to mitigate potential quality risk.

Key Responsibilities主要岗位职责:

1.Deal with Deviation issues of Products and maintenance the database.

2.Deal with customer complains of product and maintenance the database.

3.Deal with supplier complains of product and maintenance the database.

4.Deal with the quality deviations and return goods of product and maintenance the database as OQA DA investigation responsible person.

5.Deal with system of CAPA and maintenance the database.

6.Deal with reprocess/rework/repack and return of product.

7.Monitor in-process control of products' validity which conducted by VS including manufacturing in process control, packaging process control and packaging quality check.

8.Document: Prepare, review and train related SOP and batch record.

9.BPCS system: change finished product status and do double check on BOM & API system input.

10.Training the operator, involve qualifying the operator. Have good training skill.

11.Follow up CAPA of complaint and deviation.

12.Perform regular GMP inspection of products as per plan.

13.Coordinator and prepare product annual product review.

14.Monitor in-process control for product, review updated batch record.

15.Deal with the OQA related works of new product issues.

16.Perform other jobs assigned by OQA Section Manager.

17.As quality representative of BPCS system.

18.Deal with TTS/QAA responsibility

19.Prepare report Quality KPI from OQA

20.Review batch record filling.

21.Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures

Contact information:

You may apply for this position online by selecting the Apply now button.

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