Senior Associate - Downstream Validation

Pfizer; Visakhapatnam; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Pfizer Vizag site is seeking an Associate Manager to lead visual inspection and packing validation activities for sterile dosage forms.

You will develop validation protocols, support cross-functional process transfers, and drive CAPA/DMAIC projects to ensure product quality and regulatory compliance.

Qualifications

• B.Pharm/M.Pharm/M.S (Pharmacy)/M.Sc. (Pharmacy) with 6+ years of experience in Visual inspection and packing.
• Hands-on experience with visual inspection and packing automation technologies.
• Knowledge of validation concepts and ability to train staff.
• Prepare study protocols, risk assessments, CPP requirements and equipment validations.

Responsibilities

• Validate visual inspection and packing equipment for sterile dosage forms.
• Support site-to-site parenteral product/process transfer with cross-functional teams.
• Develop validation protocols for equipment and CPPs and document results.
• Prepare study protocols, gap assessments, risk assessments, and CPP parameter recommendations.
• Lead investigations related to process engineering to drive CAPAs and improvements.
• Ensure compliance with FDA guidelines and PDA practices; participate in continuous improvement.

Skills

Visual inspection

Packing

Equipment validation

DMAIC

CAPA investigations

Statistics

Education

B.Pharm/M.Pharm/M.S (Pharmacy)/M.Sc. (Pharmacy)

Tools

HVLD

Camera Vision

Line Master

Pressure/Vacuum

Job description

Why Patients Need You

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. 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. 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.

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. It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

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.
• Evaluate Visual Inspection & Packing Process Parameters/ CPPs for Scale up and Exhibit batches manufacturing.
• 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.
• Preferable knowledge on statistics for data evaluation and technical inputs
• 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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.