We are seeking for a QC Specialist to join our team to support our client in Pharceutical Industry. This is a contract role for a year subject to extention as per client's need.
Responsibilities:
- Perform microbiological analysis of raw material, GPT, ID samples according to Standard operating procedures and Test Methods
- Perform EM which includes BSC / HLFH / VLFH sampling, fingertips monitoring, compressed gases /air and water / clean steam sampling in accordance to cGMP procedures when required
- Documentation of results in accordance with cGMP
- Prepare EM trend reports, EM reports for product lot release and trend reports
- Review routine data and logbooks with supervisory audit
- General lab support including housekeeping, equipment maintenance, inventory of supplies, etc
- Problem solving of issues as well as troubleshooting of equipment
- Author or update existing SOPs, Forms and TMs as needed
- Discrepancy Owner or perform assessment of lab related discrepancies
- Involve in new equipment / methods qualification
- Participate internal and external audits and regulatory inspections
- Understanding of basic microbiological principles (bioburden, LAL, plating and counting techniques, etc) and execution of intermediate techniques (DET, AET)
- Perform equipment qualification / maintenance, liaise with external / contract lab / vendor
- Lead the continuous improvement of laboratory procedures and processes to ensure compliance to GMPs
- Comply with all client's Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable
- Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements
- A team player and the willingness to cover other colleagues in continued support of the Micro/EM testing operations.
Requirements:
- Bachelor's Degree (Chemistry, Microbiology, Biochemistry or any Life Science related is preferred)
- Minimum 1 to 3 years' work experience in the pharmaceutical or related industry preferably QC related
- Knowledge of cGMP relevant to the pharmaceutical industry
- Able to determine when to escalate issue
- Ability to organize and plan effectively
- Good team player
- Demonstrate good verbal and written communication skills in English
- Must be comfortable with contract basis role
