Pharmaceutical In Process Quality Officer

SUMMARY:
a Big Giant within the Pharmaceutical Industry is looking to employ a skillful In Process Quality Officer with Grade 12 + 6 years Quality experience or Diploma with 4 years Quality experience & Pharmaceutical Manufacturing experience to join their dynamic team of experts urgently!!!!

POSITION INFO:

Overview

Position: 

Applicants are invited to apply for this excellent opportunity that exists for the above mentioned position. The successful incumbent will report to the QA Team Leader.

Overview

• Monitor product quality throughout the manufacturing and packaging process
• Monitor QMS compliance with GMP standards
• Assist with deviations and quality investigations
• Provide input into SOPs to ensure compliance
• Related administrative tasks

Responsibilities

 Planning and Operational Support

• 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+ years’ Quality experience, or 2 year Diploma with 4+ years’ Quality 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

 

 

 

 

NB! This job is now closed. You can apply for other jobs by uploading your CV.

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