IPC Coordinator (Port Elizabeth) at Aspen Pharma Group

Job purpose

• Perform in process testing, sampling and interpret results.

Responsibilities

In Process Testing and Reporting

• Conduct in process testing, compare samples, calculate, interpret and record testing results.
• Record defect, out of specification results, reporting these as
• appropriate
• Complete required documentation, update and maintain databases and appropriate reports.
• Ensure that all documentation adheres to signing protocols.
• Handle, operate, maintain and calibrate equipment according to SOPs
• Comply to GMP/ GLP requirements at all times.

Reporting and Record Keeping

• Gather and record information, statistics and evidence required for reporting.
• Compile standardized reports and consolidate documents.
• Retrieve supporting documentation and records to facilitate and support query resolution.

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.

Stakeholder Relations

• Communicate with internal stakeholders to achieve work objectives, maintain relationships and to assist and convey information.

Requirements

Background/experience

• Grade 12
• 1 to 3 years’ pharmaceutical manufacturing experience

Specific job skills

• Broad working knowledge of concepts, terminology and specialized reporting requirements

Competencies

• Following Procedures
• Information Gathering
• Finalizing Outputs