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.
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.
Skills Required
Background/experience
National Certification (N4-N6) or Trade Tested Artisan with 2-4 yearsxe2x80x99 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.