Ensure that analytical equipment is maintained and calibrated accurately and timely in accordance to site procedures, CAP and regulatory requirements.
Lead and/or participate in investigations arising from laboratory equipment/computer systems events and propose effective CAPA to minimize reoccurrence.
Perform periodic validation review of systems /laboratory equipment in a timely manner to ensure that the validation status is maintained, and make recommendations for re-validation as required.
Lead or participate in laboratory equipment validation in accordance to site procedures and regulatory requirements, inclusive of writing, reviewing and approval of validation related documentations.
Maintain and support computer systems and laboratory equipment according to site change control and access control procedures.
Perform accurate and thorough impact assessment on laboratory equipment, systems change control to ensure all impacted areas are adequately assessed and impacted documentation are updated in a timely manner.
Revise, review and maintain laboratory procedures, instructions, methods to ensure compliance with regulatory, QMS, CAP and pharmacopoeia.
Ensure a safe working environment in the laboratory and perform 6S inspection.
Minimum Science Diploma or Degree holder
Solid 3-5 years’ experience in the field of Chemical, Pharma or Manufacturing industry. Candidates with more than 5 years’ experience can be considered for senior role.
Good knowledge of GMP and laboratory equipment/validation
Good knowledge of quality, laboratory techniques and laboratory compliance
Good knowledge of regulatory expectations /CAP/ICH requirements
Good knowledge of analytical equipment capabilities and operational needs
To apply, please visit to www.gmprecruit.com and search for Job Reference: 16082
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