Executive, Eng

About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

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Job Summary
Responsible for Qualification and validation, SOPs and Formats preparation, Training co-ordination and other Engineering GMP activities. Responsible for projects and other activities as assigned.

Job Responsibilities

• Execute all engineering operation as per established ARPL standards and procedures.
• Reports to Assistant Manager – Engineering and Maintenance at ARPL for day-to-day engineering activities of allotted Job responsibilities.
• Ensure completion of Scheduled Qualification for the Equipment like Air Handling Units, LAF (Clean air stations), Pass box system, Dust Collectors, De-Dusting booth, Compressed Air System, Nitrogen plant, Water System, Access Control system, Etc.,
• Ensure preparation of protocols and completion of Facility Qualification, IOQ, PQ for modified and newly created area as per the organization requirements.
• Ensure completion of test like Air velocity and Number of air changes, Class of Air- Non-viable Particle count, Airflow Direction/Pattern & HEPA Filter integrity for Air handling unit qualification.
• Receipt and review of Qualification Reports and Certificates from qualification service provider.
• Ensure completion of Scheduled Qualification for the Equipment like Air Handling Units, LAF (Clean air stations), Pass box system, Dust Collectors, De-Dusting booth, Compressed Air System, Nitrogen plant, Water System, Access Control system, Etc.,
• Execute / supervise the engineering department online documentation all time with respect to Equipment Qualification / Re-Qualification / Risk Assessment / Training / Re-Evaluation / Planner / Logbooks.
• Preparation, updating, Review and archival of Qualification protocols, filter replacement schedules, QSR documents.
• Prepare Performance Re-qualification protocols and reports in line with the cGMP requirements.
• Ensuring and maintaining safe workplace at ARPL all time in coordination to EHS personnel.
• Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements.
• Execute with quality assurance department for preparation and implementation of engineering department SOPs / Formats / System manual and other engineering documents.
• Ensuring and maintaining engineering inventory management /upkeep of minimum stock availability for engineering spares.
• Execute / supervise with the help of contractors on daily basis for follow up and completion of Qualification and other engineering cGMP documentation activities and projects.
• Coordinating and Attending training sessions on cGMP, Regulatory, SOP trainings, SAP trainings, latest technical & industrial developments related to Engineering.
• Address and resolve escalated complaints & grievances from user department.
• Performs all work in accordance with all established regulatory compliance and safety requirements.
• Notification creation, confirmation and TECO of Preventive Maintenance & Corrective Maintenance work orders in SAP Module.
• Demonstrate Behaviours that exhibit our organizational values 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 duties as assigned.

Job Requirements

• Education

• Minimum Diploma Engineering/Bachelor's degree in Engineering

• Knowledge, Skills and Abilities

• Having Knowledge in Calibration, Thermal Mapping, Qualification and its related Documentation.

• Having knowledge in QMS documentation.
• Having knowledge in utilities systems and equipment's.
• Having knowledge in Preventive maintenance process.
• Having good interpersonal and communicational skills.
• Having knowledge of ISPE, ISO and WHO Guidelines for pharmaceutical equipment and area Qualification.

• Shall have exposure to any of the regulatory audits like USFDA, MHRA, HC, TGA. Etc.,

• Experience

• Minimum 3 years of experience for bachelor's degree or 5 years of experience for diploma in engineering in pharmaceutical industry.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex 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.