Job Description

Job purpose

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

ResponsibilitiesPlanning 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 weekly/monthly basis

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

• Time management: handling multiple tasks at once.
• Good interpersonal and presentation skills
• Customer champion: Excellent relationship building internally and externally.
• Detail orientated.
• Information seeking: Process improvement initiative.
• Team player

Competencies

• Innovation
• Teamwork
• Attention to detail.
• Information gathering
• Tacking Action
• Planning and Organizing
• Aspen knowledge
• Optimism

Aspen Pharmacare