Antaes
Job Description:
Contribute to Life Science projects for Antaes Asia clients
Perform
sampling of raw materials under controlled conditions
(classified and non-classified areas).
Execute
analytical and/or microbiological testing of raw materials
as per approved methods (e.g. ID, purity, pH, conductivity, endotoxin, bioburden, compendial tests).
Review supplier CoAs and perform verification testing
against specifications and pharmacopeias
Document all activities and data in compliance with
GDP and cGMP
requirements.
Support
qualification of new raw material suppliers and material change controls .
Participate in
equipment qualification, method verification/validation and periodic review of raw material specifications .
Assist in
investigation of OOS/OOT results, deviations, and support CAPA implementation .
Ensure adherence to
safety, material handling and contamination control requirements
during sampling and testing.
Contribute to continuous
improvement of raw material release processes and QC workflows .
Contribute to the promotion of Antaes services on top of assistance provided to client.
Job Requirements:
Degree/Diploma in Science, Microbiology, Biotechnology, Life Sciences
or related field.
1–3 years of experience in QC microbiology
within
pharmaceutical / biologics / sterile manufacturing environment preferred.
Knowledge of
GMP, GDP, aseptic technique, sterility assurance, and relevant pharmacopeial methods
Good problem solving and analytical skills
Excellent organizational and communication skills
#J-18808-Ljbffr
Contribute to Life Science projects for Antaes Asia clients
Perform
sampling of raw materials under controlled conditions
(classified and non-classified areas).
Execute
analytical and/or microbiological testing of raw materials
as per approved methods (e.g. ID, purity, pH, conductivity, endotoxin, bioburden, compendial tests).
Review supplier CoAs and perform verification testing
against specifications and pharmacopeias
Document all activities and data in compliance with
GDP and cGMP
requirements.
Support
qualification of new raw material suppliers and material change controls .
Participate in
equipment qualification, method verification/validation and periodic review of raw material specifications .
Assist in
investigation of OOS/OOT results, deviations, and support CAPA implementation .
Ensure adherence to
safety, material handling and contamination control requirements
during sampling and testing.
Contribute to continuous
improvement of raw material release processes and QC workflows .
Contribute to the promotion of Antaes services on top of assistance provided to client.
Job Requirements:
Degree/Diploma in Science, Microbiology, Biotechnology, Life Sciences
or related field.
1–3 years of experience in QC microbiology
within
pharmaceutical / biologics / sterile manufacturing environment preferred.
Knowledge of
GMP, GDP, aseptic technique, sterility assurance, and relevant pharmacopeial methods
Good problem solving and analytical skills
Excellent organizational and communication skills
#J-18808-Ljbffr