Job Description Summary
Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area.
Roles and Responsibilities Review of batch manufacturing records and the process of manufacture, supporting the decision to release product in compliance with all license and GMP requirements; Liaising with Operations personnel to ensure regulatory and quality requirements are met during routine operations; Supporting and handling deviation / corrective action program； Monitoring the production by inspection randomly, ensuring the manufacturing process meet with compliance. Co-ordinating product complaints investigation and report； Monitoring and aiding the implementation of continuous improvements and process changes； Conducting QA activities including revision of SOPs, QA work and the new projects. Handles simple data entry work requiring face value check and correction.
Required Qualifications B.S. Degree in technical field. Minimum 1 year experience in pharmaceutical industry or a medical device. Personnel with work experience in QA or QC will be preferred. Thorough knowledge of national and international GMP requirements.
Desired Characteristics Strong oral and written communication skills. Ability to document, plan, market, and execute programs.
Note: To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years’ experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.