Research & Development Senior Specialist

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 Pre-formulation, 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 & Re-Development 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 re-optimization 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, SOP’s, 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, & Follow-up 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 non-conformity.
• 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