Ensure that all data supporting the resolution of process and method issues have sufficient accuracy to allow for the correct actions to be taken to address the issue.
Contribute to the formulation and development of the plans for the implementation of new testing technologies and methods.
Ensure a safe working environment for the laboratory through participating or issuing safety risk assessment for product specific methods, or techniques or material and performing 6S inspection.
Assist Laboratory Operation Manager in supporting laboratory budget management and Analytical Laboratory resource planning.
Involve in the approving change that may have an impact on product quality, validation and/or cGMP compliance. This may require assessment of testing requirement, co-ordinate testing of samples and comment on change documentation and ensure closure of change. Upon completion, review and ensure closure of changes.
Draft, compile, review and update appropriate laboratory documents such as testing protocol, procedures and guidelines relating to GMP and operational framework of the laboratory.
Lead or participate in investigation arising from laboratory investigation, incidents and accurately assess the impact of the failure so as to make appropriate recommendations remedial actions for follow-up.
Ensure regulatory compliance, perform Level 1 audit and support L2 / L3 / L4 audits.
Ensure timeliness and accuracy of Pharmacopoeia & CAP review.
Minimum Bachelor’s Degree in Chemistry.
At least 1-4 years’ experience in an analytical environment, preferably in the pharmaceutical industry. Candidates with more than 4 years’ experience will be consider for senior role.
GMP and GLP knowledge
Understanding product specification and method of analysis
Knowledge of laboratory instrumentation
LIMS and corporate ERP system knowledge
Laboratory support procedures
Ways of working for new product introduction
Regulatory requirements for method validation
To apply, please visit to www.gmprecruit.com and search for Job Reference:16081
To find out more about this opportunity, please contact Alexandra at: firstname.lastname@example.org
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Alexandra Calingo | Registration No: R1101491