Job Description

Job Summary Responsibilities:
Day-to-Day Support:

• Ensure that procedures and processes within area of responsibility are performed in accordance with relevant Standard Operating Procedures, Work Instructions and current Good Manufacturing Practices.

• Drive and support close out of all relevant compliance related audit findings.

• Responsible for performing line-openings and in process checks according to legislative and company requirements.

• Update GMP documents (SOP, WI, PPI and PI etc), as required and train accordingly.

• Ensure effective communication to all relevant parties.

• Ensure all production documentation and processes are completed as per cGMP guidelines.

Process Knowledge

• Understand process flow

• Understand process controls as well as risks

• Understand technically the product and its composition

• Understand process/product cost structure

• Support training to operators

Product Stewardship

• GMP, EHS and Quality compliance during the execution of the Plan and all related tasks. Ensures compliance with work instructions according to the relevant SOP's

• Initiate, investigate and close out relevant GMP and SOP compliance related NC, CAPA, Change Controls, Deviations and Customer Complaints.

• Support process transfers (in or out)

• Perform in-process audits - both planned and ad hoc accordingly to ensure that GMP standards are met and maintained.

• Support regulatory with technical documents

Continuous Improvement:

• Drive, contribute and support continuous improvement initiatives of GMP compliance and standards within the department accordingly and together with the management team.

• Analyze the process on a routine basis to identify risks or inefficiencies. Lead the execution of Improvement Projects in the area of responsibility

• Plan the implementation of improvement projects
• Perform internal assessments in production areas and develop corrective actions to strengthen cGMP

Requirements:

• Registered with SAPC as a qualified Pharmacist.

• 2-3 years pharmaceutical manufacturing experience

• Supervisory experience/qualification will be an added advantage

• Good knowledge and understanding of the SA cGMP Guide

• Good planning and administrative competencies

• Good verbal and written communication

• Logical approach to problem solving and trouble shooting

• High work standards and business ethics

Must be available to work shifts if required
Please note that only shortlisted candidates will be contacted
Manpower Group
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