Job Description

Assist in for quality management systems, control and documentation.

Key Responsibilities

• Assist in determining training needs, train cGMP and monitoring of compliance with requirements of cGMP.
• Assist in documentation and evaluation BMRs and BPRs.
• Assist Reviewing, developing of missing SOPs and implementation of SOPs.
• Handle product related customer complaints as well as execute and co-ordinate product recalls, together with supporting staff.
• Convene self-inspections and/or quality audits and make recommendations, where applicable.
• Assist in ensuring that all requisite validations are carried out.
• Investigate and set standards for quality and health and safety.
• Ensuring manufacturing processes comply with standards at both national and international level.
• Ensuring maintenance of his/her Department, premises and equipment.
  • Carry out vendor audits.
  • Assist in Preparation of training and self-inspection schedules.
  • Specify quality requirements of raw and packaging materials with suppliers.
• Ensure initial and continual training of Departmental Personnel as necessary.
  • Ensure appropriate manufacturing systems in-process controls are implemented.
• Review and authorize/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents.
• Review and authorize/reject production batch records and make the final decision to release a product lot into commerce.
• Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes.
• Review complaints to determine if it relates to a failure to meet specification, if so investigate and report to regulatory authorities if serious and unexpected.
• Be independent reviewer and authorizer with respect to manufacturing and process/ product development units.
• Establish Quality procedures and standards.
• Authorize written procedures and other documents.
• Control and archiving of records and documents.
• Prepare Corrective actions and preventive action (CAPA) records.
• Retrieval and filling of complete BMRs and BPRs