QC Lab Manager

1 Month ago • 10 Years +

Job Summary

Job Description

The QC Lab Manager will be responsible for managing testing and release of raw materials, packaging materials, and finished products, ensuring a continuous supply of quality materials for production. This includes overseeing the stability program, managing laboratories, ensuring efficient and compliant operation, implementing eLM processes, and ensuring the quality system adheres to GMP standards. The role requires interactions with various departments and knowledge of GMP standards, as well as experience in team management, process understanding, and a pharmaceutical environment.
Must have:
  • 10+ years experience in a pharmaceutical environment
  • Proven process understanding (Pharma, GMP)
  • Experience with Manufacturing Site needs
  • Experience in team management

Job Details

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question. 

 

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special. 

Job Purpose:

Manages testing and release of raw materials (excipients, API) and secondary pack materials ensuring continuous supply of quality material to the production team for finished product and API manufacturing. Manages testing of finished products for full product portfolio of Nyon site (Liquids and Semi solids) Manage the stability program including the testing for marketed products, active substances and medical devices that are manufactured on the site: lead annual stability studies, post approval stability, post approval change stability, registration stability, reworked batch stability testing and annual validation stability. Ensures oversight and performance for the full scope of the QC area including QC support services within the QC organisation. Ensures efficient and compliant operation of the QC laboratories.

Key Responsibilities :

Ensure the operation of the analytical and packaging laboratories to support the introduction, validation, stability, quality control and release of pharmaceuticals/raw materials /packaging materials in accordance to GMP standards (local and global procedures) and health authority expectations and specifications.

Establishes and maintains departmental performance objectives and links departmental performance to individual goals and objectives through the performance review process. Maintains a high-performance work team and ensure associates development in line with the skills required by the business, their aspirations and their capabilities and potential.

Organisation and Continues improvement

o Coordinates QC product testing and laboratory support functions according to site procedures.

o Is responsible of the QA Release of the Raw Materials and Consumables in MERP according to site procedures.

o Manage the annual/monthly/weekly stability planning and follow the stability program according to the ICH and regulatory requirements.

o Responsible for instruments and facilities for QC including stability chambers (qualification/maintenance/alarm 24h)

o Ensure that the lab technicians provide timely, accurate analytical data which is recorded according to Testing Monographs, SOPs and Regulatory Dossier, deputy approver of Testing instructions.

o Ensure processes are efficient without compromise to quality of the finished product. Manages the development and implementation of workflow optimization initiatives, which positively impact cycle time, productivity and quality of work.

o Take responsibility for the implementation of eLM process (eLM=Excellent Laboratory Management) in Nyon site including active participation at eLM Global Project

Quality System

o Installation of a proper problem shooting process ensuring continuous improvements on lab investigations, OOS

o Ensure adequate assessment and timely closure of deviation, events within laboratory operations and stability program– provide team support where needed

o Ensures quality systems in laboratories are developed and implemented in accordance to QMS and ensures review and approval for cGMP documents including: test methods, specifications, lab investigation, deviations, OOS, corrective and preventive actions, applicable validation protocols and reports, SOPs….

o Provide inputs for the PPR review process for all products

o Technical responsible towards Health Authorities for controlled drugs management.

o Respect all GMP standards. GMP knowledge and experience to support the requirements expected by Swissmedic, European union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system.

o Ensures adequacy of training for full QC organization

Interactions

o Represent the QC department as primary contact, and ensure strong relationship with operations, supply chain, finance, all departments of the Q organization; Liaise with the business partners and ensure cooperation and support with regards to efficiency programs

o Participate in PIRC and PIRC plus process as QC expert

Knowledge/ Education required:

  • Minimum 10 years’ experience in a Pharmaceutical Environment, with at least 5 years in Quality Control / Analytical

  • Proven process understanding (Pharma, GMP, investigation and method development)

  • Experience with Manufacturing Site needs and constraints

  • Experience in team management

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Accommodation Requests

If you require a reasonable 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 accommodations you are requesting. We’ll provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.

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About The Company

Hello. We’re Haleon. A new world-leadingconsumer healthcarecompany. Shaped by all of us. Together, we’re improving everyday health for millions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol,Advil, Voltaren,Theraflu, Otrivin,and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re building together. In anenvironment thatwe’re co-creating. And a culture that’s uniquely ours. Care to join us.

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