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).
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 email@example.com
Bo Zhuang Mian
Manpower Staffing Services (S) Pte Ltd
Alexis, Zhuang Mian Bo EA License No.: 02C3423 Personnel Registration No.: R1872731