QMS Manager needed at Adcock Ingram

Requirements

• B. Pharm degree
• Active Registration with the South African Pharmacy Council
• cGMP skills
• Computer literacy:   MS Office, Excel , Word , Power Point
• 3 years in Pharmaceutical Manufacturing environment
• 2 -3 years Quality Assurance experience
• QMS and Pharmaceutical Knowledge

Responsibilities: 

• To ensure and maintain an effective Quality Management System in accordance with relevant regulatory and AI guidelines.
• Ensure the handling and maintenance of all customer complaints are in compliance with SOPs.
• Ensure that customer complaint samples are obtained from customers, where available, to aid in the investigation and customer complaint investigation reports are reviewed to determine the adequacy of the identified root cause and proposed CAPA’s.
• Ensure that critical customer complaints are reviewed and assessed immediately, investigation status, progress and related test results of critical customer complaints are followed up on and weekly status reports of critical complaints.
• Ensure the management and close out of all AIL product customer complaints, review trends including that of recurring complaints. Conducting an Assessment of the identified risk to product quality, patient safety and product efficacy for complaints received, engage with various Stakeholders within the Business Units and the escalation of recurring complaints
• Ensure that customer complaint training is provided to required Adcock Ingram staff.
• Ensure handling of all Change Controls are in compliance with written procedures and appropriate changes are documented and logged with GQA- QMS.
• Ensure the review, approval and close-out Change Controls as per approved SOP and status of Change Controls are reported on a monthly and quarterly basis.
• Ensure handling of all Deviations are in compliance with written procedures and root cause of a Deviation is investigated and documented, appropriate CAPAs are identified to address the root cause to prevent any re- occurrences.
• Ensure that appropriate Deviations as set out in the Technical Agreements between the Applicant (Adcock Ingram Limited) and each respective contract manufacturer (Adcock Ingram and non-Adcock Ingram) are documented and logged with GQA-QMS.
• Ensure the review, approval and close-out of Deviations as per approved SOP and the status of Deviations are reported on a monthly and quarterly basis.
• Ensure handling of all CAPAs are in compliance with written procedures and appropriate CAPAs are identified to address the root causes of non- conforming events that are derived from various sources e.g., Customer Complaints, Deviations, Self-Inspections, PQRs, QMR, Management Escalations
• Ensure the review, approval and close-out CAPAs as per approved SOP and status of CAPAs are reported on a monthly and quarterly basis.
• Ensure an effective Self-Inspection program exists within the Applicant, Adcock Ingram Limited, which adequately measures compliance with GMP requirements.
• Ensuring that Self-Inspections are conducted in accordance with an approved annual schedule and status reported on a monthly and quarterly basis in accordance with the approved procedure.
• Ensure an effective recall system is implemented and managed in accordance with SAHPRA guidelines and the effectiveness of the Recall system is reviewed and assessed periodically by conducting a Mock Recall.
• Ensure the implementation of CAPA/s implemented due to the recall are completed and that the CAPAs effectiveness with sites or contract manufacturing are checked in accordance with the relevant CAPA procedure.
• Ensure that training on Recall/Withdrawal Procedure is provided to required Adcock Ingram staff.
• Ensure that all records and registers are maintained and the close off of a recall following completion of CAPA and final reconciliation of returned product, distribution records and destruction certificate is obtained
• Report on the progress of any recall initiated to the GQA Manager and AIL RP on a monthly and quarterly basis
• Managing the preparation and execution of the Mock Recall and ensuring effective implementation of CAPAs identified.
• Review of Technical agreements compiled between Adcock Ingram Limited/Adcock Ingram Healthcare and a Contract Giver noted for customer complaints, Recall responsibilities. Ensure that all Technical Agreements are tracked, logged on a register and stored in a secure location.
• Ensure the effective management of the Management Escalation process and that all significant events reported to the Applicant are thoroughly investigated and appropriate CAPAs are implemented to prevent any re- occurrences
• Ensure the status of Management Escalations are report on a monthly and quarterly basis in accordance with the approved procedures.
• Ensure that all Quality related documentation is controlled in accordance with written procedures and that an effective documentation system exists to manage, the issuance of copies, track review dates of SOPs, hard copies and electronic copies of Master Documents, the distribution of SOP copies and the implementation, superseding and obsoleting of SOPs
• The review and authorization of QMS and other departmental SOPs are conducted timeously.
• Ensure that the status of documentation / SOPs reported on a monthly and quarterly basis on to the GQA Manager
• Maintaining and managing an effective Training procedure, which ensures continuity of management of various QMS processes and the development of GQMS department employees in accordance with the requirements of the SAHPRA guidelines
• Ensure that all Job descriptions are reviewed and approved for the Quality Management Systems department in accordance with the approved procedure.
• Ensure continuous training is provided to all employees within the QMS department in accordance with each employee’s Training Plan and that the status of SOP training is reported on a monthly and quarterly basis.
• Management of the Quality Risk Management process by ensuring that a documented procedure is followed and providing support to all who need to perform Risk Assessments which shall be added to Adcock Ingram’s Quality Risk Register whereby appropriate CAPAs are identified and implemented.
• Ensure that the Quality Risk assessments conducted are reported on a monthly and quarterly basis in accordance with the approved procedures.
• Ensure Stability and Analytical OOS results, as set out in the Technical Agreements between the Applicant (Adcock Ingram Limited) and each respective contract manufacturer (Adcock Ingram and non-Adcock Ingram) are documented and logged with GQA-QMS.
• Ensure that an effective, accurate tracker/register of all OOS reports logged are maintained and that OOS reports received are reported on a monthly and quarterly basis.
• Departmental management, preparation and participation in Contractual Partner Pharmacovigilance audits conducted by ensuring GQMS procedures are compliant with regulatory requirements and CAPAs identified are timeously implemented.
• Departmental management, preparation and participation in SAHPRA audits by ensuring the GQMS procedures are complaint with SAHPRA requirements and CAPAs identified are timeously implemented.
• by ensuring the GQMS procedures are complaint with SAHPRA requirements and CAPAs identified are timeously implemented.
• Management and escalation of all overdue QMS documentation namely, SOPs, change controls, Deviations, CAPAs, Self-Inspections, Management Escalations etc; to relevant departmental/Functional Managers to ensure the effective implementation of Group QMS procedures.
• Preparation and Execution of the Group Quality Assurance Quality Management Review conducted Quarterly in accordance with the procedure.
• Ensuring effective management and implementation of Quality Management System Processes modules and other departmental modules via CaliberQAMS Electronic Systems.
• Ensuring the administration of System Manager activities of the software are effectively managed by the CaliberQAMS administrator and that Disaster recovery and CaliberQAMS Reports are generated, reviewed and assessed as per the SOP.
• Ensuring the registration of new Users and maintain existing users on the system in accordance with the approved procedures
• Ensuring timeous logging of faults/tickets by the CaliberQAMS system administrator on CaliberQAMS Support Portal Helpdesk System and resolution of faults by Caliber Technical Teams.
• Monitoring the performance of the CaliberQAMS software in accordance with the approved procedure.
• Ensuring monitoring of the QMS team, for closures of open Change controls, Deviation and CAPA’s on the CaliberQAMS System.
• Managing Internal Application audits conducted by Group Internal Auditing and ensuring the effective implementation of CAPAs identified.
• Where applicable, and within scope of authorised procedures, the delegation as a designee to review and sign documentation on behalf of the GQA Manager, GQA department Managers namely the CM Manager, PQR Manager, Audit Manager