Quality Control 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

The QC Manager is responsible for overseeing all quality control activities within the manufacturing facility. This includes ensuring compliance with GMP regulatory requirements and internal quality standards. The role involves managing laboratory operations supervising testing of raw materials in-process samples and finished products and ensuring timely and accurate release of materials

Project Start Up Phase

Role Responsibilities

  • Analytical & Micro Lab Equipment procurement
  • Analytical & Micro Lab Equipment Set UP
  • People Qualification Process Set Up
  • Equipment Validation protocol drafting
  • Test method Validation/ Verification protocols Drafting
  • People Qualification Process Set Up
  • SOP and Test Method Documents Finalisation
  • IP Methods applicability Matching and Mapping

Commercial Start up

1. Quality Control Operations

  • Manage day-to-day activities of the QC laboratory (chemical microbiology instrumentation).
  • Ensure testing of raw materials intermediates finished products and stability samples as per approved specifications.
  • Review and approve test results COAs (Certificates of Analysis) and analytical reports.

2. Compliance & Regulatory

  • Ensure compliance with cGMP GLP and regulatory requirements (USFDA MHRA WHO etc.).
  • Support regulatory inspections and audits.
  • Implement and maintain SOPs protocols and quality systems.

3. Documentation & Review

  • Review analytical data logs records and reports for accuracy and completeness.
  • Ensure proper documentation practices (GDP) are followed.
  • Handle OOS (Out of Specification) OOT (Out of Trend) deviations and CAPA.

4. Laboratory Management

  • Oversee calibration maintenance and qualification of laboratory instruments.
  • Manage laboratory inventory reagents and reference standards.
  • Ensure proper environmental controls in lab areas.

5. Team Management

  • Lead train and mentor QC staff.
  • Allocate work and monitor performance.
  • Ensure adherence to safety and quality standards.

6. Stability & Validation

  • Monitor stability studies and review related data.
  • Support method validation transfer and verification activities.

7. Continuous Improvement

  • Identify areas for process improvement and implement best practices.
  • Ensure efficient use of resources and reduction of turnaround time.

Once the site is operational

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.

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 place

Why you

Basic Qualifications:

  • 5 years relevant experience in Pharma / FMCG in the area of manufacturing quality or technical operations.
  • Msc Micro Biology or MBA / PGDBM./ BPharma/Mpharma

Preferred Qualifications:

  • Sound professional experience in Quality Assurance GMPs Quality Systems and technology operations.
  • Excellent planning and organization skills.
  • Good knowledge of analytical & Micro laboratory activities.
  • Strong knowledge of analytical techniques (HPLC GC UV IR dissolution etc.)
  • Thorough understanding of GMP / GLP guidelines
  • Experience in handling audits and inspections

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...

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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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