Associate Manager – Visual Inspection | Pfizer | Vizag

Job Description

As a Senior Associate Scientist, you will be at the center of our operations and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality. Your significant experience in applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team.

You will perform qualitative and quantitative analyses of organic, and inorganic compounds, or biologics to determine chemical and physical properties during chemical syntheses, fermentation, or drug product development process. Your skill and knowledge will help in making decisions that require choosing among limited options. You are proactive in contributing to all team discussions and creating an environment of collaboration.

It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

Role & Responsibilities:

• Hands-on experience in Visual inspection & packing automation technologies. (SD, Camera Vision, HVLD, Pressure/Vacuum, line master, etc.,)
• Provides support for site-to-site parenteral product/process transfer by interfacing with cross-functional departments across sites.
• Prepare study protocols, Gap assessment, Risk assessment reports, recipe parameter recommendations, and CPP requirements in the developed recipe parameters.
• Evaluate Visual Inspection & Packing Process Parameters/ CPPs for Scale up and Exhibit batches manufacturing.
• Actively support the execution of Process Validation batches, Equipment Qualifications, and validations/recipe establishment.
• Familiar with US FDA Guidelines, PDA & industry practices thereby implementing Continuous Improvement Projects.
• Troubleshooting, ongoing technical support to Manufacturing team for Process validation, Continuous Process Verification and Process improvement
• Actively involve and drive Investigations related to Process engineering and Equipment to evolve CAPAs and monitor the effectiveness of CAPAs. Be able to apply the DMAIC tool to drive investigation studies.
• Independently carry out all aspects of practical work necessary to provide right-first-time results.
• Responsible for performing Engineering batches, scaleup batches, and Exhibit batches as part of technology transfer activities.
• Attend project team and brainstorming meetings and present data.
• Hands-on experience in Visual inspection & packing automation technologies. (SD, Camera Vision, HVLD, Pressure/Vacuum, line master, etc.,)
• Provides support for site-to-site parenteral product/process transfer by interfacing with cross-functional departments across sites.
• Prepare study protocols, Gap assessment, Risk assessment reports, recipe parameter recommendations, and CPP requirements in the developed recipe parameters.
• Evaluate Visual Inspection & Packing Process Parameters/ CPPs for Scale up and Exhibit batches manufacturing.
• Actively support in the execution of Process Validation batches, Equipment Qualifications, and validations/recipe establishment.
• Familiar with US FDA Guidelines, PDA & industry practices thereby implementing Continuous Improvement Projects.
• Troubleshooting, ongoing technical support to the Manufacturing team for Process validation, Continuous Process Verification, and Process improvement
• Actively involve and drive Investigations related to Process engineering and Equipment to evolve CAPAs and monitor the effectiveness of CAPAs. Be able to apply the DMAIC tool to drive investigation studies.
• Independently carry out all aspects of practical work necessary to provide right-first-time results.
• Responsible for performing Engineering batches, scaleup batches, and Exhibit batches as part of technology transfer activities.
• Attend project team and brainstorming meetings and present data.

Qualifications

Must-Have

• Bachelor’s Degree or any equivalent degree
• 6+ years of experience
• Experience with Visual inspection & packing automation technologies. (SD, Camera Vision, HVLD, Pressure/Vacuum, line master etc.,)  .
• Ability to extract relevant information from scientific literature, accurately record observations, facts, data and conclusions during studies or Good Manufacturing Practices {also cGMP} investigations
• Interact effectively with peers and leaders as part of a multi-disciplinary team
• Effective verbal and written communication skills

Nice-to-Have

• Masters degree
• Certified in Problem-solving skills – Yellow belt / Green belt.
• Experience in a {Current} Good Manufacturing Practices {part of GxP} laboratory
• Understanding of various scientific software or software used in pharmaceutical or production environment
• Desire to develop their own technical skill set is essential.