Quality Compliance Manager

GSK


Job Location:

Gurgaon - India

Monthly Salary: Not Disclosed
Posted on: 2 hours ago
Vacancies: 1 Vacancy

Job Summary

Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve grown evolved and are now entering an exciting new chapter one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands including Sensodyne Panadol Advil Voltaren Theraflu Otrivin and Centrum lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now its time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose to deliver better everyday health with humanity at the heart of everything we do. It unites us inspires us and challenges us to be better every day driven by our agile performance-focused culture.

About the role

This role will lead the Quality compliance to the new facility Perform the risk assessment. Review QMS related documents and will be responsible for setting QMS for the new facility.

Role Responsibilities

Project Start up Phase:

  • Timely input to the facility/ process/ equipments/ logistics quality requirements.
  • Ensures that appropriate systems are implemented and maintained
  • influences operational and production facility GMP design supplier management and site strategy.
  • Ensures the right validation protocols are developed for the new site validation and documentation.
  • Regulatory Standards Matching and Mapping
  • Preparing Validation Master Plan for Site
  • QMS Documents ( SOP/NCR/ Investigations) Process Set Up
  • QA SOP and documents drafting
  • Change Control process Set for Manufacturing Site
  • Coordination for ISO Audit QMS Documents
  • Risk Assessments as Per ICH guidelines

Once the site is operational: Commercial production

  • Ensures that all aspects of the site Quality and Manufacturing tasks comply with the Haleon Quality Manual and meet all relevant cGMP and regulatory requirements.
  • Collaborate closely with the Site team to operate in a cross functional and cost-effective manner to foster productivity improvement and implementation of best practices.

Key responsibilities

  • Timely input to the facility/ process/ equipments/ logistics quality requirements.
  • Ensures that appropriate systems are implemented and maintained
  • influences operational and production facility GMP design supplier management and site strategy.
  • Ensures the right validation protocols are developed for the new site validation and documentation.

Once the site is operational

1. Quality Management System (QMS)

  • Develop implement and maintain QMS in line with regulatory requirements
  • Oversee SOP creation review approval and periodic updates.
  • Ensure compliance with internal quality policies and procedures.

2. Documentation

  • Ensure accurate documentation in compliance with Good Documentation Practices (GDP).

3. Deviations Investigations & CAPA

  • Review and approve deviations OOS OOT investigations.
  • Ensure root cause analysis is conducted and effective CAPA is implemented.
  • Track and ensure timely closure of quality events.

4. Change Control Management

  • Manage and approve change control processes.
  • Evaluate impact of changes on product quality and regulatory compliance.

5. Audit & Compliance

  • Lead internal audits self-inspections and vendor audits.
  • Prepare for and manage regulatory inspections
  • Ensure audit observations are addressed with appropriate CAPA.

6. Validation & Qualification

  • Oversee validation activities (process validation cleaning validation equipment qualification).
  • Review and approve validation protocols and reports.

7. Training & Development

  • Ensure GMP training programs are conducted regularly.
  • Train and mentor QA team members and cross-functional staff.

8. Risk Management

  • Implement Quality Risk Management (QRM) principles (ICH Q9).
  • Identify quality risks and ensure mitigation strategies are in plac

Why you

Basic Qualifications:

  • 5 years relevant experience in the healthcare industry in the area of manufacturing quality or technical operations.
  • Graduate in Science Btech Bio / Msc Chem / Micro/BPharma with experience in Cosmetics and pharma regulations

Preferred Qualifications:

  • Sound professional experience in Quality Assurance GMPs Quality Systems and technology operations.
  • Excellent planning and organization skills.
  • Knowledgeable in auditing and inspection against regulatory / quality standards.
  • Champions Haleon Shared Values; especially quality and customer focus leadership excellent ability to make decisions in balancing risks taken and to propose solutions
  • Ability to identify opportunities for continuous improvements and execution across the organization
  • Should be good in conflict management

Job Posting End Date

Equal Opportunities

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture where different backgrounds and views are valued and respected all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. Its important to us that Haleon is a place where all our employees feel they truly belong.

During the application process we may ask you to share some personal information which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development refinement and execution of our inclusion and belonging programmes that are open to all Haleon employees.

The personal information you provide will be kept confidential used only for legitimate business purposes and will never be used in making any employment decisions including hiring decisions.

Adjustment or Accommodations Request

If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process please let your recruiter know by providing them with a description of specific adjustments you are requesting. Well provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.

Note to candidates

The Haleon recruitment team will contact you using a Haleon email account (@). If you are not sure whether the email you received is from Haleon please get in touch.


Required Experience:

Manager

Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve grown evolved and are now entering an exciting new chapter one filled with bold ambitions and enormous opportunity.Our trusted portfolio of brands i...

About Company

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About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

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