Job Description :
Purpose : Specialist - the role holder is responsible with for the implementation of all Julphar’s procedures, and policies and assists the production department in complying with all regulations to increase effectiveness.
Ensure adherence cGMP principles and maintains them in effective manner. Responsible to carry out the upstream and downstream operations in the Julphar plant.
Responsible to ensure and monitor the smooth running daily activities of the department. Must assess current procedures, track data, manage schedules, maintain important documents, database, preparing reports, analyze performance, and communicating relevant information to department.
Key responsibilities & Accountability : Key Responsibilities & Key Result Areas Ensure implementation of all Julphar’s procedures, and policies in department and overall compliance with regulations.
Responsible to ensure the smooth running day-to-day activities of the department.Responsible for doing all production / purification activities as per cGMP.
Work with standard scientific equipment as described for relevant process; AKTA Purifier and AKTA Pilot chromatography systems, Roller bottle incubators, CO2 incubators, chromatography columns, biosafety cabinets, centrifuge, autoclaves, weighing balances, pH meter, refrigerators and freezers.
Responsible for safety and security of production area.Check the status of equipment calibration / preventive maintenance and validity of stored raw materials and consumables.
Prepare and participate in the approval of the batch manufacturing documents like MFM, SOP’s etc.Fill, maintain, and review the batch records dedicated for Production / Purification steps to ensure the quality standards are met.
Assists with investigation, root cause analysis, and corrective action / preventative action (CAPA) implementation.Maintain and operates machinery used in batch manufacturing based on operating procedures.
Prepare plan by checking production schedule, studying requirements, clarifying specifications, calculating calibrations, weighing components, assembling materials and stocking supplies.
Responsible to maintain and analyze operational data, document all production efforts in appropriate logs, forms, reports and databases.
Prepare and present reports that reflect audit results and document process.Responsible to prepare Standard Operating procedure (SOP) for related Plants and update on the same as required for any changes.
Monitor production process validation is as per the standard procedures.Ensure that the products are manufactured as per the GMP to achieve consistent results and documented accordingly.
Work with production teams to ensure cost-effective, high quality and timely delivery of products.Ensure that final product meets quality standards and customer specifications.
Check and maintain all related logbooks and records.Use SAP to approve work orders, manage equipment and drive maintenance work practices.
Generate SAP notification for calibration due or maintenance.Plan and assign daily job duties to workers to fulfill the plan.
Overseeing human resources department policies, training, and performance reviews.Must work in close coordination with the department to gather in-depth understanding of the nature of their function to be able to provide the needed support to it.
Preform any other work assigned by Manager and support colleagues whenever necessary. Core CompetencyIn terms of competency you are highly oriented with strong sense of accountability & ownership.
High on compliance adherence, having strong eye for process details.Excellent communication, interpersonal, and collaboration skillsProfessional and should be able to juggle competing priorities.
Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area goals.
Must be able to multitask, task prioritize without guidance and easily adopt to changing situations.Ability to work effectively under pressure and meet established deadlines.
You must have excellent understanding of Pharmaceutical Business with strong implementation skillsMotivated and highly organized professional and should be able to juggle competing priorities.
Having a solution centric mind to explore different scenarios and suggest resolution wherever applicable Qualifications : - Education 4 years Bachelor Degree in of Pharmacy or Science or any other equivalent field - Experience : At least 6-8 years’ experience in the same filed.
Previous experience in a similar role and with experience in a Pharmaceutical / Healthcare Industry is preferred. - Training : Key Competencies : Good Command in English (Communicating, writing and speaking) is mandatory.
Proficient in MS Office.Strong Knowledge with SAP System, SOP writing, and GMP compliance.Knowledgeable with Production plans and organizing Production schedules. Technical Competencies :