Job Description

Overview

Monitor product quality throughout the manufacturing and packaging process. Monitor QMS compliance with GMP standards as well as assist with deviations and quality investigations. Provide input into SOPs to ensure compliance and complete any related administrative tasks.

Responsibilities

Planning and Processes

• Plan and coordinate administrative activities
• Provide recommendations on process improvements

In-Process Quality Management

• Verify production plans for operation effectiveness
• Perform line opening visual inspections as per checklist
• Perform end-of-batch internal inspections to assess compliance and effectiveness of overall QMS
• Perform on-line inspections of batch documents during manufacturing and packaging process to assess compliance
• Perform inspections to monitor GMP compliance during manufacturing ? Perform inspection of logbooks, SOP files and AQL
• Perform final inspection of finished goods
• Raise deviations for non-conformances identified
• Record and report quality problems as they are identified
• Compile and issue report on non-conformances and ensure adequate CAPA plans have been implemented
• Assist with product and quality investigations
• Review and provide input into SOPs to ensure compliance to GMP standards and product specifications
• Establish and apply continuous improvement processes
• Monitor and audit compliance to regulatory and in-house standards with regards to current GMP
• Participate in audits when required
• Participate in unit risk assessments

Reporting

• Coordinate and consolidate the gathering of information for reporting
• Compile detailed reports and documents
• Monitor and control data integrity in all databases

Communication

• Communicate with employees and management, to assist and convey information

Skills Required

Background/experience

• Grade 12 with 6+ yearsxe2x80x99 related experience, or 2 year Diploma with 4+ yearsxe2x80x99 related experience
• Pharmaceutical manufacturing experience

Specific job skills

• Strong working knowledge of pharmaceutical quality operations and quality management systems
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Information Gathering
• Following Procedures
• Capturing Facts
• Taking Action

Aspen Pharmacare