Principal Responsibilities
— Perform review of Lab analysis results on final product to ensure compliance to customer requirement.
— Support Quality Systems and ensure effective use of Quality Tools for activities related to Good Manufacturing Practice and Good Distribution Practice.
— Assist in the writing/co-ordination of SOPs and manage the administration of SOPs.
— Assist in timely investigation of product complaints and ensure adequacy and timely implementation of corrective action and preventative action.
— Assist in GMP audits, validation, qualification and change control implementation.
— Assist in maintaining Product Quality and Technical File.
— Assist/Coordinate potential recall activities, including mock recalls.
— Assist/Coordinate and perform self-inspection. Support inspection from regulatory authority and certified body.
— Assist in Investigation / assess deviations occurring during transport, packaging, storage, distribution of products.
— Work with various departments on maintenance of company quality manuals pertaining to operating procedures.
— Any other tasks assigned by Senior Quality Engineer/Quality Manager.
Required Key Skills (Functional/Technical)
— Good Experience in Quality Assurance with basic knowledge in Good Manufacturing Practice and Good Distribution Practice.
— Systematic, meticulous, analytical approach to evaluation and execution of tasks and a good team player.
— Good organization, excellent time management and interpersonal skills.
— Possess good analytical skills and able to conduct root cause analysis of defects / non-conformances.
— Capable to work independently and collaboratively with personnel of all levels.
— Demonstrate good ability in usage of Microsoft applications.
Required Qualifications/Experience
— Education:
· Diploma in pharmacy, chemistry, biology or health sciences.
— Experience (may vary depending on site size/scope):
1 or 2 years’ of work experience, in operational quality is advantageous.
