Senior Associate - Downstream Validation

Role overview

Senior Associate - Downstream Validation at Pfizer

Responsibilities

• Evaluate Visual Inspection & Packing Process Parameters/ CPPs for Scale up and Exhibit batches manufacturing.

Preferred qualifications and skills

• Preferable knowledge on statistics for data evaluation and technical inputs

Employment details

• Location: India - Vizag

Application details

• Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

About the employer

• Pfizer’s purpose is to deliver breakthroughs that change patients’ lives.
• It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
• Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Additional role details

• Why Patients Need You
• Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most.
• What You Will Achieve
• As an Associate Manager, 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 of applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team.
• Your skill and knowledge on Visual Inspection & Packing will help in making decisions that contribute for robust process of the products that are being manufactured at Vizag site.
• You are proactive in contributing to all team discussions and creating an environment of collaboration.
• How You Will Achieve It
• B.
• Pharm/ M.
• Pharm/M.S (Pharmacy)/M.Sc. (preferably with the specialization of Pharmaceutics or Industrial Pharmacy) , 6+ years of experience on Visual inspection and packing equipment validation function in sterile dosage form facility, Formulation Development/ Product Development/ Process Development/ Technology Transfer/ Production of Injectable formulations to cater regulated market
• 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.
• Knowledge on the Validation concepts and ability to train the people.
• Able to develop Validation protocols for equipment.
• Prepare study protocols, Gap assessment, Risk assessment reports, recipe parameter recommendations, and CPP requirements in the developed recipe parameters.
• Actively support in execution of Process Validation batches, Equipment Qualifications, validations/recipe establishment.
• Familiar with US FDA Guidelines, PDA & industry practices there by implementing Continuous Improvement Projects.
• Trouble shooting, 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 DMAIC tool to drive investigation studies.
• Independently carry out all aspects of practical work necessary to provide right first-time results.
• Preparation of Defect kits for Visual Inspector qualification and Inspection Machine qualifications.
• 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.
• To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
• Quality Assurance and Control