Senior QA Specialist (Compliance) - Pharmaceutical

Location Singapore, Singapore
Job reference Exp-HCLS_1557898320
Salary AWS
Consultant name Alexis Bo Zhuang Mian
Consultant email alexis.bo@experis.com.sg
Consultant contact no. 65515307
EA License No. 02C3423
Consultant Registration No. R1872731

Main Duties and Responsibilities

  • You will support regulatory filling for active pharmaceutical ingredients (API).

  • You will work with other departments (manufacturing operations, process team, warehouse etc) to coordinate preparation of CMC documents.

  • You will ensure compliance activities are carried out as per approved procedures and policies.

  • You will conduct audits (internal, supplier and regulatory) to ensure compliance to company's Quality Systems.

  • You are the key person to handle change controls and deviation investigations and the key user of GMP compliance systems e.g. QTS, PDOCS.

  • You will review and approve GMP documents.

  • You will be the subject matter expert for regulatory queries and interact with representatives from Global Chemistry Manufacturing and Compliance (GCMC) teams).

Candidate Profile

  • You have a Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.

  • You have at least 3 years of Quality Assurance/Compliance experience in pharmaceutical GMP-regulated industries.

  • You have strong knowledge of GMP compliance regulations.

  • You are familiar with regulatory filling for API (experience for major markets such as US, China, Japan would be advantageous).

  • Applicants with experience in Trackwise system would be advantageous.

Interested applicants please send your resume to alexis.bo@experis.com.sg

Bo Zhuang Mian

R1872731

Manpower Staffing Services (S) Pte Ltd

02C3423

Alexis, Zhuang Mian Bo EA License No.: 02C3423 Personnel Registration No.: R1872731