Analytical Support Officer (1 year contract) | UK Pharma | West

GMP Technologies; Singapore; Vor Ort; SGD 43.000 - 60.000; Vollzeit

Zusammenfassung

GMP Technologies is seeking an Analytical Support Officer on a 1 year contract in the UK Pharma West region. You will ensure equipment calibration, lead CAPA investigations, perform validation reviews, and support change/ access controls in a fast-paced lab environment.

The role requires a science degree with GMP and lab validation knowledge, and the ability to ensure regulatory compliance. Prior experience is not mandatory. Shortlisted candidates only will be contacted.

Qualifikationen

• Min. Science degree holder with experience in Chemical, Pharma or Manufacturing industry
• 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
• Candidates with no prior experience will be considered

Aufgaben

• Ensure analytical equipment are maintained and calibrated accurately and timely per site procedures and regulatory requirements
• Lead and/or participate in investigations arising from lab equipment/computer system events and propose CAPA to minimise recurrence
• Perform periodic validation reviews of systems/lab equipment to maintain validation status and recommend re-validation as needed
• Lead/participate in laboratory equipment validation per site procedures and regulatory requirements, including writing/reviewing validation documents
• Maintain and support computer systems and lab equipment according to change control and access control procedures
• Perform impact assessments on equipment and systems changes to update impacted documentation timely
• Revise and maintain lab procedures to ensure compliance with regulatory, QMS, CAP and pharmacopoeia
• Ensure a safe working environment in the lab and perform 6S inspections
• Supervise and develop staff to help achieve department objectives
• Conduct effective training for lab staff on computer systems/equipment and procedures
• Ensure regulatory compliance, perform Level 1 audit and support L2/L3/L4 audits
• Ensure timeliness and accuracy of Pharmacopoeia & CAP reviews

Kenntnisse

GMP knowledge

Lab equipment validation

CAPA investigations

Regulatory compliance

6S in lab

Ausbildung

Science degree

Jobbeschreibung

Analytical Support Officer (1 year contract) | UK Pharma | West

Job Openings Analytical Support Officer (1 year contract) | UK Pharma | West

About the job Analytical Support Officer (1 year contract) | UK Pharma | West

• Ensure that analytical equipment are 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.
• Supervise, develop and motivate team members and other assigned staff to help realize their maximum potential so as to contribute towards achieving the objectives of the department.
• Conduct effective training for laboratory staff on computer systems/equipment and relevant procedures.
• Ensure regulatory compliance, perform Level 1 audit and support L2 / L3 / L4 audits
• Ensure timeliness and accuracy of Pharmacopoeia & CAP review

Requirement:

• Min. Science degree holder with experience in the field of Chemical, Pharma or Manufacturing industry
• 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
• Candidates with no prior experience will be considered

We regret that only shortlisted candidates will be notified.

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