Senior Associate - Downstream Validation

Biopharma Careers; Visakhapatnam; Presencial; INR 1 500 000 - 2 500 000; Tempo integral

Resumo da oferta

Pfizer Healthcare India Private Limited, Vizag, India, is seeking a Senior Associate for downstream validation focusing on visual inspection and packing validation for sterile dosage forms. The role emphasizes protocol development, cross-functional coordination, and process optimization to ensure compliant manufacturing.

You will validate equipment, prepare protocols and CPPs, and support process validation batches while collaborating with QA, manufacturing, and validation teams in a fast-paced

Qualificações

• 6+ years of experience in visual inspection and packing validation for sterile dosage forms.
• Ability to develop validation protocols and CPP requirements.
• Knowledge of US FDA guidelines and PDA practices.
• Ability to lead investigations using DMAIC for CAPAs.

Responsabilidades

• Validate equipment and processes for visual inspection and packing in sterile dosage forms.
• Prepare study protocols, gap & risk assessments, and CPP parameter recommendations.
• Support process validation batches and equipment qualifications.
• Train staff on validation concepts and procedures.
• Drive CAPA investigations and monitor effectiveness using DMAIC.

Conhecimentos

Visual inspection

Packaging validation

HVLD

Line Master

DMAIC

Formação académica

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

Ferramentas

Camera Vision

HVLD

Line Master

Descrição da oferta de emprego

# Senior Associate - Downstream ValidationVizag, India Full timeOther / Corporate Functions SeniorNotify me about similar jobsView Full Job & Apply at Pfizer Healthcare India Private LimitedPfizer Healthcare India Private Limited is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.## About this opportunity**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 marketHands 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 improvementActively 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.## Job detailsSenioritySeniorFunctionOther / Corporate FunctionsTherapeutic areaNot listedLocationVizag, IndiaEmployment typeFull time