Roles & Responsibilities
Responsibilities :
- Responsible for the timely completion and data verification of all testing of raw material, intermediates, in-process control samples and final product
- Maintain up-to-date, complete and precise records of all tests performed
- Ensure that all test equipment is used and maintained properly in GMP environment
- Acts as an SME for simple to complex instruments and techniques where needed
- Lead and perform any method transfer or method validation protocols or equipment qualifications and support the transfer of new products
- Understands, implements and maintains cGMP and 65 concept
- Able to present clearly and lead confidently during audits and site leadership inquiries
- Write / revises procedures as necessary and make recommendations for process improvement
- Effectively perform a multitude of laboratory techniques for which they are trained on with minimal error
- Trains new analysts and technicians on all instruments / techniques, as well as routinely reviewing that all API lab personnel are adhering to proper GMP standards
- Responsible for assisting the lab supervisor in following up with corrective actions
- Responsible for ownership of laboratory investigation - Able to lead the whole laboratory investigation and work alongside with QA for success closure of investigation
- Participate in tier meeting for manufacturing updates on incoming raw materials / in-process samples and final API
- Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements by driving all EHS standards, procedures and policies
About You :
Bachelor of Science majoring in Biology, Chemistry, Biochemistry or related scientific degreeAt least 5 years of experience in a QC LabAt least 1-3 years of experience in a pharmaceutical manufacturing environmentStrong GMP background and proficient with using laboratory equipmentHighly motivated, independent and able to work under pressurePossess good interpersonal and communication skillsStrong analytical, problem solving and writing skillsTeam motivator — able to motivate and be role model for less experienced peersTotal commitment to quality and maintaining a high standard of work at all timesMust be able to do rotating 12-hour shift work (day and night shifts)Job Type : Contract
Contract length : 12 months. Option to extend / renew subject to performance review.
Tell employers what skills you have
Biochemistry
Test Equipment
Team Motivator
Process Improvement
GMP
Investigation
Chemistry
Laboratory Techniques
Biology
Audits
Analytical Problem Solving
Laboratory
Manufacturing
Writing Skills
Analytical Instruments
EHS