Executive, Prod-Compress-ARPL-PLCR AR

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma.

Job Summary

• Responsible role-holder to handle/supervise the manufacturing process and related activities of Compression, Encapsulation & Coating section.
• To ensure the on-time production and delivery of product with quality compliance and as per cGMP requirement, company policies, sops and good documentation procedure.

Job Responsibilities

• To execute, review and supervise the below listed activities

• To plan, organize and co-ordinate in the execution of operation and cleaning of compression, encapsulation and coating activities.

• Line Clearance

• Area and Equipment cleaning verification
• Initiation of swab request and any other applicable sample requests (As applicable)
• Initiation of equipment, instrument and area breakdown notifications.
• Review of executed batch records and equipment/area usage, calibration logbooks
• Execution of SAP related activities.
• Execution and review of in-process tests at different stages of processing

• To get the issued batch records, logbooks and to return the completed executed batch records, logbooks to QA.

• To undergo and participate in relevant department and cross functional trainings (as and when assigned) in learning plan.

• Creation, Control, Maintenance and Revision of Equipment Master Recipes as per SOP.
• To be a Qualified visual inspector as per Qualification process to handle necessary activities in compression, encapsulation & coating section.
• To work inline with the cGMP requirement like (but not limited to) equipment and area status Labelling, environmental conditions and pressure difference monitoring, Weighing, daily area sanitization and cleaning monitoring, audit readiness and Hygiene practices to be followed.
• To prepare daily reports of production activities, achieving production schedules and daily meetings.
• To execute and supervise the batch as per instruction given in batch document (MMaR)
• To follow and adhere to safety and compliance aspects in all the steps in the production area.
• To perform and involve in all other duties, equipment/area qualification, documentation and execution activities assigned by respective supervisor based on business and compliance requirement.
• Responsible for Calibration / Preventive maintenance of the Equipment / Instruments is done as per the schedule and status verified.
• To train the concern members on the related SOP's , newly updated SOP's , Awareness Training, Protocols and other relevant documents as on required.
• Handling and allocation of manpower as per production schedule.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

Education

• Minimum degree in B.Pharmacy / M.Pharmacy

Knowledge, Skills And Abilities

• Proficient knowledge of Good Manufacturing Practices (GMPs) & Good Documentation Practices.
• Efficient communication, strategic thinking and problem solving skills.
• Adequate knowledge to understand the written procedures and policies.

Experience

• Minimum 4 to 5 years of experience in the production process.

At ApoPharma, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. ApoPharma offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.