Pharma Process Optimization Section Head

Job Description

Responsible for recording the quality assurance activities, follow up each production process step, investigate the production and process problems and solving it and recording of all the production steps monitoring at the batch records.

Follow up the different processes in WH are done according to good storage practices and relevant SOPs.

Follow up the check list of the RH, temperature at the different places at the warehouse and production areas as per the relevant SOPs.

Perform inspection on the destruction process for the rejected finished products, raw materials and packaging materials.

Perform inspection on the raw and packaging materials and ensure their compliance with the acceptance criteria.

Perform inspection on the gowning procedure according to the SOP.

Perform inspection on different manufacturing activities in the production areas and their compliance with the relevant SOPs and batch records.

Check the environmental monitoring execution in the sterile area.

Perform different IPC tests required during different production stages as per the batch record.

Responsible for sampling the samples required by the quality control department as the bulk, semi-finished and finished products samples.

Reviewing batch records after process compilation according to Company QMS.

Recording all the deviations which occur at all the production process and writing and /or participate in the corrective and preventive action.

Participate in any complaint investigation to identify the root causes of the problem and solving it, as per the IPC supervisor or quality assurance process control section head directions.

Participate in internal or external audits whenever requested, and prepare the needed reported points for the conducted audits.

Work through, follow and adhere to safety instructions and requirements in concerned areas.

Work according to GLP, GMP and GDP rules.

Shall be consulted and participated in the EHS management system and its improvement elements via reporting actions / incidents those could occur or occurred and attend the relevant trainings.

Skills

Bachelor's degree in pharmaceutical sciences or sciences.

Understanding of methodologies and best quality assurance practices.

Knowledge of documentation reviews and requirements analysis.

Ability to troubleshoot and resolve complex issues effectively.

Ability to work well through others.

Ability to meet workloads and project deadlines.

Excellent English, verbal / written communication.

Excellent computer skills.

Education

Pharmaceutical Science or Science

• Years of Experience Min: 3 years