3 Who Guidelines Jobs

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. For more information visit: www.apotex.com. 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&aposs 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 equipments. 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 bachelors 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. Show more Show less

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into project timelines and deliverables. Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements. Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions. Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed. Participate in internal and external audits and inspections related to regulatory compliance. Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation Qualifications Bachelors degree in a science, pharmacy, or a related field; advanced degree (e.g., Masters, PhD) preferred. Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry. Skills Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams. Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.

As a Process Head at Kavs Spectronova Technologies Pvt Ltd, you will be responsible for leading the process engineering aspects of pharmaceutical plant projects. Your role will involve overseeing optimal process design, ensuring regulatory compliance, and facilitating seamless coordination among internal and external stakeholders for both greenfield and brownfield facility projects within the pharmaceutical industry. Your key responsibilities will include leading the end-to-end process design for various types of pharmaceutical facilities such as OSD, Injectable, Vaccine, or Biotech. You will be required to develop and review essential documents including P&ID, Process Flow Diagrams, Mass Balances, Equipment Sizing, and Critical Design Parameters. Additionally, you will prepare and evaluate User Requirement Specifications (URS) and oversee various tests and validation protocols such as FAT, SAT, DQ, IQ, OQ, and PQ to ensure compliance with regulatory standards like GMP, WHO, USFDA, and EU. Collaboration with cross-functional teams such as R&D, Quality Assurance, HVAC, Utility, Electrical, Instrumentation, and Automation will be a crucial part of your role. Your technical expertise and leadership will be essential during project execution, commissioning, and regulatory audits. Client meetings, technical presentations, and troubleshooting activities will also be a part of your regular responsibilities, along with international travel for projects, site visits, audits, and technical review meetings. To qualify for this position, you should hold a Bachelor's or Master's degree in Chemical Engineering or Pharmaceutical Engineering with 8 to 12 years of experience in process design and execution of pharmaceutical plant projects. A deep understanding of regulatory requirements including GMP, WHO, USFDA, and EU is essential. Demonstrated leadership skills in managing diverse teams and external consultants/vendors, excellent communication, documentation, and presentation abilities, as well as the capability to handle multiple projects under strict timelines are required. A valid passport is mandatory for this role, and prior international exposure is highly desirable. In return, we offer you a challenging leadership role in global pharmaceutical projects, opportunities for international exposure and career advancement, a collaborative work environment that emphasizes innovation and compliance, as well as competitive compensation and benefits in line with industry standards. To apply for this position, please send your updated resume to suchita@spectronova.com with the subject line: Application for Process Head Pharma Projects.,