QA and Ra Scientist

**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.
- 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