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Production Compliance Specialist

1 week ago

Cape Town, Western Cape, South Africa Staff Unlimited Recruitment Pty Ltd T A MPC Recruitment Group EC Full time
Job Description

Staff Unlimited Recruitment Pty Ltd T / A MPC Recruitment Group EC is seeking a Production Compliance Specialist to support production processes to ensure these processes are compliant, reliable, and efficient.

Responsibilities
  1. Day-to-Day Support: Ensure that procedures and processes within the 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.
  2. 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.
  3. Product Stewardship: GMP, EHS, and Quality compliance during the execution of the Plan and all related tasks. Ensure 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.
  4. 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.