Process Lead - Product Life cycle

Job Summary:

Support the technical aspects of a product during product transfer, product troubleshooting and change assessment in accordance with regulatory requirements, implement stage 2 (product qualification) based on stage 1 (product development), Improvements/recommendations based on the output of stage 3 (APQR), product remediation in addition to aseptic process simulation and product transport validation.

Main Responsibilities:

1. Responsible for Process validation activities (Stage-II), Preparation and review of protocols and reports.
2. Providing support for the review of Stage-I Documents like Process Optimization documentation. (PO Protocols & Reports, analytical Test method).
3. Responsible for the product remediation plan. (follow up with CFT related to OOS, OOT, Process reformulation, Regulatory affairs variation, planning team for the process validation and stability charging)
4. Involved in the strategy of New product launch and ensure that validation deliverables are well aligned with the management timeline.
5. Responsible for the Visual inspection Qualification process.
6. Preparation and review of validation deliverables protocols and reports for the process validation, Visual inspection, gowning qualifications etc.
7. Collaborate & work closely with both R&D teams and manufacturing sites to enable successful on-time product launches.
8. Responsible for the Aseptic Process simulation studies for sterile injectable plants.
9. Responsible for the gowning Qualification process for sterile injectable plants.
10. Responsible for the review of SOP and batch records based on the validation outcome.
11. Work with area owner(s) to ensure the initiation and implementation of scheduled activities for the Qualification.
12. Handling of Validation system related QMS like deviations, change controls and CAPA’s etc.
13. Responsible for management for validation documents like archiving, retrieving and distribution.
14. Responsible for the transport validation. Designing the protocols, executing the activities, follow up with the stakeholders and finalizing the report.

Additional Responsibilities:

1. Implementing current Good Manufacturing Practices (cGMP) complying with national and international health authorities’ requirements for Julphar plants.
2. Responsible for the successful transfer of processes into production. Ensure process scalability and manufacturability. In addition, the incumbent will coordinate all process relevant major deviations and process adaptations and will be responsible for continuous improvement of the manufacturing processes.
3. Contributes to the troubleshooting/remediating and process/product optimization of existing formulations for quality improvement and process optimization.
4. Responsible for process validation, aseptic process simulation and transport validation protocols and report preparation.
5. Collaborate & work closely with both R&D teams and manufacturing sites to enable successful on-time product launches.
6. Contributes to the evaluation, remediation and optimization of products and processes using statistical tools to ensure safety, quality, delivery, and cost standards.

Qualifications / Key Experiences / Functional Knowledge Requirements

• 7-9 years in pharmaceutical industry in validation & qualification sections in core pharmaceutical manufacturing plant is preferred.
• Knowledge of regulatory guidelines relevant to EU GMP, FDA, WHO guidelines and ISPE GAMP guidelines are required.
• Real Time Experience in the companies having GMP approval from USFDA/MHRA/TGA/ANVISA/EU authorities.