Job Purpose

• Lead scientific investigations in QC Lab
• Develop systems and processes for conducting investigations within GMP requirements.
• Evaluate analytical equipment and techniques.
• Reduce on Laboratory OOS with effective Preventative Actions
• Improve efficiency by reducing repeats.
• Trend and analyze OOS data to identify improvements

Responsibilities

Planning and Operational Support

• Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives.
• Determine, request, and allocate assets and resources for fulfilment of work objectives, and monitor its use.
• Apply advanced understanding of area of specialisation.
• Analyse concepts and suggest streamlined procedures.
• Identify training needs of QC staff.

Deviations Investigations

• Lead all scientific investigations within the QC Lab
• Lead the identification, investigation and reporting of OOSs, deviations, and other nonconformities according to GMP requirement and SOPs.
• Identify OOS data trends to establish any systematic issues in process, testing, calibration, or maintenance.
• Implement plans to reduce and mitigate OOSs.
• Perform impact and risk assessments of CAPA plans on process compliance.

Reporting and Record Keeping

• Compile complex reports and documents according to GMP requirements.
• Update records and systems as required.
• Ensure that recordkeeping complies with legal requirements.
• Monitor and control access to databases in area of responsibility.

Requirements

Skills Required

Background/experience

• Post Graduate Degree/ Diploma in Chemistry/ Analytical Chemistry with 2 to 4 years’ related experience.
• Experience in quantitative and instrumental analysis in QC laboratory environment.

Specific job skills

• Extensive experience in scientific principles and laboratory techniques and methodologies
• Scientific report writing skills.
• Understanding of pharmaceutical manufacturing, standards, and compliance requirements
• Ability to interpret and implement policies, processes, and objectives.

 Competencies

• Information Gathering
• Interrogating Information
• Offering Insights