Job Description

KEY RESPONSIBILITIES

RA: Product registration

Conduct timeous compilation of due diligence on new dossier and communicates findings to Lupin or Third-Party Supplier as required Compile and submit any TB and/or ARV dossiers to regulatory authorities in eCTD at agreed timelines Liaise with regulatory authorities on New Dossiers, SAHPRA queries and variations when required Ensure that Site Master Files are submitted to regulatory authorities for Overseas Third Party Supplier) Conduct due diligence on variations received from Third Party Suppliers or internal requirements Ensure any variations are logged on the CCP register and managed until completion Compile and submit all responses to regulatory authorities queries, Safety Updates and variations, within agreed and specified time limits. Manage the GMP compliance of API's and manufacturers on an ongoing basis and ensure any deviations or potential quality risks are communicated to the Responsible Pharmacist Maintain the department's online apps (CCP database, docuBridge, Artwork app) as per official SOPs and/or working instructions. Ensure all dossier related procedures, templates and quality standards are adhered to Ensure all correspondence and or dossier information is filed appropriately Maintain an accurate product history and ensure the electronic database for regulatory dossiers are current and accurate Review product artwork and ensures compliance with registration and labelling regulations of Medicines and Related Substances Act 101 of 1965, in line with tender requirement. Interact with Lupin and Third-Party Suppliers on dossier related activities (supplier meetings) Provide regulatory advice to internal and external stakeholders when required.

QA: Product realization & Lifecycle activities:

Ensure that timelines related to launch processes and product lifecycle maintenance are adhered to and that formal processes exist to govern product realization. Oversee and execute quality assurance operations for the preparation and release of products. Oversee and coordinate Lot Release preparations for products, ensuring compliance with GMP, the registered dossier and prescribed procedures. Ensure that laboratory consumables are effectively procured and managed thereby ensuring timelines are met for any testing activities. Compilation, conducting periodic updates and completion of Technical Quality Agreements related to product realization, if required. Co-ordinating and conducting the Product Quality Reviews to assess the ongoing effectiveness of quality systems of newly launched products. Manage Analytical Method Transfer and Stability processes to ensure accurate and reliable testing. Conduct risk assessments and develop mitigation strategies where required. Coordinate activities involved with product realization and product reworks, if required. Ensure technical transfers or validation activities are performed as per the functions stipulated for the project team. Ensure timelines are strictly adhered to. Assist with the compilation and/or review of departmental QMS documentation. Ensure destructions are recorded and managed effectively when required. Ensure that good documentation practices are always adhered to and that data integrity is maintained. Conduct supplier audits to ensure compliance and quality of incoming products. Initiate Issue Logs and drive investigations to track and address quality-related concerns promptly. Ensure correspondence with authorities is handled (e.g. for permits, etc.) is handled effectively and timeously. Oversee and coordinate Lot Release preparations for launch batches, ensuring compliance with GMP, the registered dossier and prescribed procedures. Attend and/or present training sessions as and when required. Liaise with 3rd parties and internal stakeholders to ensure product realization is effectively coordinated. Ensure stakeholder reporting is performed as and when the need arises. Ensure that master data is maintained and kept up to date. Actively seek and implement continuous improvement activities to ensure that reporting team maintains a competitive industry advantage. Coordinate and/or prepare applications for PIT exemption for submission to SAHPRA. Ensure that master data is maintained and kept up to date. Perform any other duties as per operational requirements of the department.

Good Manufacturing Practice

Maintain all GMP principles in line with departmental Quality Management System and SAHPRA/PICs GMP requirements.

General

Perform any other duties as per changes in operational requirements of the department. Ensuring goals and objectives of direct report align with GIB departmental strategies. Assist with Product Development and Product Technical Transfer projects.

PRE-REQUISITES

B.Sc. degree or equivalent scientific qualification. Minimum of 1-2 years Regulatory hands-on experience, preferably within the pharmaceutical industry. Proven experience in quality assurance within the pharmaceutical industry, with a focus on new product launches (advantageous). Detail-oriented with strong analytical and problem-solving abilities. Demonstrated ability to drive continuous improvement and implement best practices in quality assurance. Strong knowledge of regulatory requirements, including SAHPRA, Africa and international guidelines. Able to perform all standard registration processes under specialist guidance. * Experience in other areas of pharmaceutical industry such as production and/or analytical environment would be advantageous