Job Scope
To Supervise & Perform R&D Technology activities of R&D Technology formulation Toll and troubleshooting activities To Ensure effective compliance to regulatory guidelines supporting Process & Product conformity throughout Product life cycle.
Roles & Responsibilities
- Reviews Preparation & Designing New products development including Preformulation lab Scale trials scale up trials Pilot batches and Validation batches to ensure that all Product Required information are provided and considered effectively
- Supervises & Aligns Development & ReDevelopment Current product Updates with stakeholders to ensure compliance with internal procedures industry regulations Product Specifications and regulatory guidance documents
- Supervises & Performs Troubleshooting Deviations & Changes in product composition manufacturing process Or Specifications aligning stakeholders to ensure Deviation Corrective action & process reoptimization Complying to Regulatory Standards throughout Product life cycle.
- Supervises Technical Evaluation for New suppliers of raw materials to Ensure Supplier RM Conformity & Prevent Possible Technical issues may arise during manufacturing of the production batches.
- Reviews required Documents for local External registration & Formal Authorities (BPR specification and sampling plan) to ensure Documents accuracy& Conformity to Regulatory Standards.
- Supervises & Performs Technology transfer activities for Toll manufacturing to Ensure Toll Manufacturing Conformity to Technology & Product Specifications Guidelines.
- Monitors & Follow up Compliance to defined Rules SOPs Systems Policies Guidelines Decisions & Communicated targets fulfills other related tasks asked by management raised by Business Need. To Ensure internal alignment & commitment to Company & Corporate Rules
- Monitors & follow up function Team Compliance to HSE Regulations Standards & Instructions Reports unsafe conditions & be familiar with defined emergency plans.
- To Ensure a Safe Work Environment & zero Accidents.
- Monitors & Followup Compliance to defined Quality Standards Measures & Systems. Prepares & Attends related Audits Updates & Monitors implementation & closing of related CAPAs if any. To Ensure meeting Quality Standards avoiding risk of nonconformity
- Monitors & Follow up Compliance to HR Policies Regulations & Targets Attends training assigned on time Accepts & Assumes Lead Responsibilities as per delegation. To Ensure self & Team good awareness & meeting required qualifications.
- Reviews & Updates Function related Processes Reports & Indicators before submission to ensure process & documents conformity to standards
Qualifications & Work Experience
- BSc. Degree Pharmacy with relevant Qualifications
- Minimum 5 Years of relevant experience
Remote Work :
No