Senior QC Analyst (Microbiology/ Pharma/ Contract)

Senior QC Analyst (Microbiology/ Pharma/ Contract)

12 Months Contract

Location : Gul Circle (5 mins walk from MRT)

Basic Salary : Up to $5,500 depending on experience

Industry : Pharmaceutical

Responsibilities

• Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans
• Performing his/ her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirements
• Ensuring that is trained and qualified to the assigned analytical testing that requires to be qualified
• Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans
• Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately
• Participating actively to any investigation, where is involved, to ensure investigations and impact assessment are performed appropriately
• Executing assigned CAPAs related to remediation plans, continuous improvements
• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately.
• Owning assigned stability studies, in compliance with approved stability program
• Ensuring the issuance and review of all deliverables related to assigned stability studies, such as risk assessment, protocols, reports, data trending, deviations, and summary reports
• Ensuring that sampling and testing related to stability is executed in a timely manner and stability results trend performed on time, including reports issuance
• Ensuring that all expected stability data (including events, change control…) are compiled in a proper way, to provide appropriate data trending and statistical analysis of stability studies, in compliance with associated stability protocols

Additional Accountabilities

• Review analytical results and perform audit trail review before batch release.
• Carry out on-the-job training for General and Specific Analytical Method to QC analysts and chemical technicians, by incorporating cGMP and safety aspects of the procedures.
• Perform troubleshooting of equipment in the laboratory and provide guidance to QC analysts on the troubleshooting.
• Trained and work independently on specific testing method
• Ensure availability of workplace risk assessment and safe working procedures for contractors and the quality personnel. Ensure safe working in all areas of work by practicing and communicating safety message at +QDCI Sanofi Manufacturing System (SMS) Awareness, Life Saving Rules (LSR), GMP/Data Integrity Awareness
• Other responsibilities that are not included in the above are related to quality assignments.

Lim Pey Chyi (Apple) - [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423