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Manager-QA

  • Job
    Full-time
    Senior Level
  • Research & Development
  • Mumbai

AI generated summary

  • You need a Pharmacy degree, 8+ years in R&D/Quality, strong QA knowledge, FDA understanding, and proficiency in Microsoft Office. Experience in the pharmaceutical industry is essential.
  • You will manage quality systems, support technology transfers, oversee supplier management, review specifications and validation documents, and assist in audits, CAPA, GxP training, and compliance projects.

Requirements

  • This role requires a degree in Pharmacy, management, FDA understanding or a related field preferred.
  • Previous experience as a technical departments like Operation, R&D, Quality supervisor or a similar management position.
  • Strong working knowledge of Quality Assurance department, Experience in Pharmaceutical industry, and management.
  • Proficiency in Microsoft Office and data entry software.
  • Minimum of a Degree in Pharmacy - experience as a combination of Quality / R&D / Projects.
  • Minimum of 8 years of experience in Technical departments like R&D, Quality, etc.
  • Experience in Pharmaceutical industry (FDA understanding).
  • Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance – including those related to risk-based approach and quality design (ICH Q8 – Q12).

Responsibilities

  • Quality system management at external manufacturing sites:
  • Support for technology transfer.
  • Supplier management related, etc.
  • Support for review & approval of technical specifications.
  • Review & approval of validation and transfer documents.
  • Support in planning, supervising, and reporting of stability.
  • Activities for Change Control Management, QSF Management, Investigations - Complaints Management, CAPA management, Assessment Management via any other tool as an when implemented.
  • Support for self-inspection audits, CAPA compliance reports, etc.
  • Support in GxP training activities.
  • Support in Quality technical agreement management as an when required.
  • Support quality and compliance related projects for Contract Manufacturing sites.
  • Data compilation, reporting of scorecard.

FAQs

What is the job title for this position?

The job title is Manager-QA.

Where is the job location?

The job location is Mumbai.

What is the main responsibility of the Manager-QA?

The main responsibility is to manage day-to-day activities ensuring quality and compliance at external manufacturing sites involved in the manufacturing and supply of P&G Products.

What qualifications are preferred for this role?

A degree in Pharmacy, management, FDA understanding, or a related field is preferred.

How much experience is required for this position?

A minimum of 8 years of experience in technical departments like R&D or Quality is required.

What type of industry experience is relevant for this role?

Experience in the Pharmaceutical industry, particularly with an understanding of FDA regulations, is relevant.

Who does the Manager-QA report to?

The Manager-QA reports to the Sr. Manager, Quality Assurance.

What are the key tasks involved in quality system management at external manufacturing sites?

Key tasks include technology transfer support, supplier management, reviewing and approving technical specifications and validation documents, and managing Change Control and CAPA processes.

What software proficiency is required for this job?

Proficiency in Microsoft Office and data entry software is required.

Is this a full-time position?

Yes, this is a full-time position.

Does the role involve compliance with regulatory requirements?

Yes, ensuring compliance with regulatory and legal requirements is a critical aspect of the role.

What kind of training support does this position offer?

The role involves supporting GxP training activities.

What does 'GMP' stand for in the context of this job?

GMP stands for Good Manufacturing Practices.

What is the job segmentation for this position?

The job segmentation is for Experienced Professionals.

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Manufacturing & Electronics
Industry
10,001+
Employees
1837
Founded Year

Mission & Purpose

P&G was founded more than 185 years ago as a soap and candle company. Today, we’re one of the world’s largest consumer goods companies and home to iconic, trusted brands, including Always®, Charmin®, Braun®, Fairy®, Febreze®, Gillette®, Head & Shoulders®, Oral B®, Pantene®, Pampers®, Tide®, and Vicks®. The design, development, growth and success of these products—and many more—is thanks to the innovative and insightful minds of our people. From Day 1, you’ll help make everyday life easier for our 5 billion consumers. There is no single equation for success at P&G, because no two P&G people or careers are alike. Just as we strive to deliver a superior consumer experience, we aim to deliver a superior employee value equation as well. With our large global footprint, there are many opportunities to work with P&G in multiple locations. We offer opportunities in approximately 70 countries and continually aim to attract, reward and advance the finest people in the world. Here, we want you to get your career off to a fast start. That's why we don't have any rotational development programs or gradual ramping-up periods: you’ll be able—and encouraged—to dive right in from Day 1. Join us and help make life better through meaningful work that makes an impact from Day 1.

Culture & Values

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  • Trust

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