Job purpose

• Perform validation exercises of production and lab equipment, utilities, packaging, and processes to ensure specific standard of compliance is met.

Responsibilities

Planning and Operational Support

• Act as a technical/ subject matter resource
• Facilitate implementation of current processes
• Identify gaps in current policies and procedures.

Validation

• Perform validation exercises in compliance with GMP standards and validation schedules.
• Maintain compliant status of equipment and processes.

Qualification

• Perform the relevant operational qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as per intended use.
• Perform the relevant performance qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as intended over time and within limits.
• Investigate and report OOE results and perform re-tests.
• Participate in change control assessments to ensure compliant status of affected equipment is not compromised.
• Conduct routine inspections of equipment and utilities to identify any deficiencies and ensure quality standards are being adhered to
• Ensure documents and procedures to operate and maintain equipment are in place.

Requalification

• Assess and recommend re-qualification of equipment and utilities as appropriate as per Protocol.
• Prepare and perform re-qualification of equipment and utilities as per SOP.

Reporting and record keeping

• Compile, maintain and update validation documentation as per SOP and QMS
• Generate validation reports on a weekly/ monthly basis.

Requirements

Background/experience

• National Certification (N4-N6) or Trade Tested Artisan with 2-4 years’ related experience
• degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience
• Aseptic pharmaceutical manufacturing process and automated packing experience

Specific job skills

• Comprehensive knowledge in the application of Qualification and Validation principles pertaining to aseptically filled products.
• Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives.

Competencies

• Interrogating information
• Maintaining accuracy
• Following procedures
• Technical writing