Durban - Our client, a Leading Global Pharmaceutical Company requires a Person-in-the-Plant (PiP) from a QA & Compliance point of view for the oversight of pharmaceutical third-party manufacturing operations on-site.
Specific Objectives : The position will be QA representative at the External Manufacturing (EM) sites and will be located at the EM sites most of the time in order to ensure a timely response and / or action.
Will serve as a contact point within the QA Organisation for other departments with respect to quality relevant subjects.
The position supports the effective and compliant execution of tech transfer activities and development of necessary quality systems at the EM sites and associated off-site storage locations.
Support site qualification activities and development / maintenance of quality agreements in accordance with Company standards.
Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure Company products / processes comply with cGMP requirements.
Support regulatory submission activities, and lead inspection readiness activities in partnership with EM site and JJRC to support global health authority approvals.
Following successful tech transfer, support quality oversight for day-to-day production activities, including deviation and CPA management, escalation of critical issues, and change control.
To ensure continued supply of all products that are manufactured by the EM, the position can also be involved in the follow-up of open topics in supply chain, logistics and planning.
Specifically in such cases, the position will interact with the account manager of the EM. Monitor EM quality performance and proactively identify risks and mitigation plans through benchmarking and knowledge sharing.
Ensures that all relevant QA related concerns at the EM site are raised to the Company’s management. Will ensure that the manufacturing operations for Company at the EM site run smoothly from a QA point of view and in a compliant manner.
The position will pro-actively identify risks and potential issues and delays and, where possible, resolve them. Where resolution is not possible, escalation to the relevant level of management is supported.
The position will represent Company QA in product quality investigations and timely provides input to support close out with a minimum impact on the supply chain.
The position will represent Company QA in change control handling, if relevant for Company products. Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc) to meet patient supply requirements.
Support the preparation of audits of the EM sites by Company Regulatory and Compliance. Review the corrective actions plan proposed by the External Manufacturer and follow-up on the remediation of each identified observation.
Prepare follow-up reports and document the tracking and closure of observations in the Company TrackWise system. Monitoring of timely supply of Product Quality Reports (PQRs) by the EM according to schedule.
Documented review of PQRs in collaboration with Company’s management. Acts as a backup for the reviewing and monitoring of Customer Complaints in the ETS database.
Interaction with the complaint handling department of the EM to follow-up on investigations; secondary review of serious complaints.
Supplemental investigation of internal complaints. Coordinates the external support to ESI Q EMEA in this matter. The position requires solid knowledge in all quality systems concerning the aseptic manufacture of sterile, liquid dosage form products : Bachelor’s Degree with a concentration in engineering, science, or an equivalent technical discipline Minimum of 8 years work experience in a regulated pharmaceutical environment Detailed knowledge of cGMPs related to pharmaceutical production Strong interpersonal and written / oral communication skills Ability to quickly process complex information and make critical decisions with limited information required Advanced degrees are a plus and may reduce the experience required Bachelor’s Degree with a concentration in engineering, science, or an equivalent technical discipline