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