QC Instrumentation Specialist

Desired Skills: Lab equipment,documentation,change controls,risk assessments,protocols

The Role:

Key strengths in the area of QC equipment qualification and project management is highly desirable.

Responsibilities:

Generation, review and approval of Laboratory Equipment Qualification lifecycle documentation including change controls, risk assessments, protocols, reports etc.

Execution of IQ/OQ/PQ protocols for laboratory equipment e.g. HPLC, UPLC, Dissolution Systems, GC etc.

Generation of ERES assessments, operational procedures, PM/CAL procedures and schedules.

Co-ordinate vendor activities and

Coordination and scheduling of laboratory equipment vendors to support PM/CAL of laboratory equipment.

Troubleshoot instrumentation/test methods and associated Corrective Maintenance.

Provision of Equipment Qualification status updates at governance forums.

Escalation of risks and implementation of appropriate mitigations.

Perform system administrator duties for stand-alone laboratory equipment e.g. method setup, account creation etc.

Perform system periodic reviews for existing laboratory equipment as per defined schedules.

Coordinate planning, organization, and implementation of laboratory equipment projects within specified objectives.

Lead and coordinate investigations involving deviations from governing procedures and processes.

Timely completion of assigned GTrack change controls, CAPAs and tasks.

Requirements:

Proficiency in Microsoft Office including Microsoft Project as an added advantage

5+ years’ of relevant experience and a BS degree in Chemistry or equivalent.