- Perform validation exercises of production and lab equipment, utilities, packaging, and processes to ensure specific standard of compliance is met.
Planning and Operational Support
- Act as a technical/ subject matter resource.
- Facilitate implementation of current processes
- Identify gaps in current policies and procedures.
- Provide input into changes or improvements to processes, tools, and techniques.
- Perform validation exercises in compliance with GMP standards and validation schedules.
- Maintain compliant status of equipment and processes.
- 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.
- 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.
- Compile, maintain and update validation documentation as per SOP and QMS
- Generate validation reports on a weekly/ monthly basis.
- 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
- 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.
- Interrogating information
- Maintaining accuracy
- Following procedures
- Technical writing
