Quality Control Analyst

icon building Unternehmen : Haleon
icon briefcase Auftragstyp : Vollzeit

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Arbeitsbeschreibung - Quality Control Analyst

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.

Here in Haleon Dungarvan we are looking for a Quality Control Analyst, this role is responsible for the Analysis of Raw Material, Intermediate, Stability samples and/or Finished Products, Micro duties / training including: Completion of Micro environmental testing, micro analysis of Raw Material &

Finished Products, may be assigned as required.

Key Responsibilities :

Primary deliverables expected of the role:

  • Permit and promote only expected Haleon behaviours and activities,
  • Sampling and testing activities carried out in line with GLP and business targets,
  • Achieves Lead-time targets (and proactively addresses barriers to achievement),
  • Adheres to full EHS compliance in QC and site activities,
  • Adheres to full GLP compliance in QC and site activities,
  • Adheres to DI expectations,
  • Ensures QC documentation is completed in accordance to cGLP or cGDP practices, including records in site
  • electronic systems e.g. M-ERP / VQMS / LIMS etc.
  • On time completion of CAPAs and other site metrics.
  • Completes On-The-Job Training process & maintains own training record through the span of employment in
  • the company.
  • Supports PPR (Medicinal only) and other site processes,
  • Ownership of Laboratory CI Processes, support of site CI / HAPs projects.
  • Excellent communication/interpersonal skills with a strong affiliation with customer support.
  • Accountable for all aspect of one’s work and must have a can-do attitude.

Impact of role on business objectives:

  • Ensure QC team work in a safe manner and in accordance with GxP,
  • Training of QC team for specific tasks in accordance with GxP,
  • Decision-making and liaison with internal departments in order to gather information in order to disposition
  • product in accordance with GMP,
  • Liaison with corporate colleagues as required to resolve issues,
  • Highlighting issues to the Quality Control Manager / Quality Control Team Lead (or designee), OQ Manager
  • and Quality Director as appropriate.
  • Reviewing completed analytical reports prior to OQ approval,
  • Preparation and review of in-house procedures (SOPs),
  • Troubleshooting analytical problems,
  • Scheduling in-house functions to ensure that the QC team operates as efficiently as possible and that product
  • lead times are maintained,
  • Support site CI / HAPs projects.
  • Assist the QC function in preparation for, and during external agency audits and internal Haleon audits.

Environmental Health & Safety (EHS) Responsibilities:

  • Perform duties in a compliant manner and behave in accordance with site SOP’s, Haleon EHS standards and
  • guidelines and relevant legal requirements.
  • Read and understand Standard Operation Procedures applicable to role.
  • Report all accidents, incidents and any EHS issues using the appropriate process /system to your line manager
  • or, if required, the Occupational Health Advisor.
  • Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping
  • standards.
  • Be aware of the impact of your job activities on EHS issues,
  • Correct segregation of waste for disposal or recycling with a focus on overall waste reduction.

Quality Responsibilities:

  • Perform duties in a compliant manner and behave in accordance with our Quality Management System
  • requirements / DI principles (ALCOA+)
  • Participate fully in our site’s quality initiatives and ensure that all relevant quality standards are adhered to
  • maintain GMP standards where appropriate.
  • Read and understand relevant Standard Operating Procedures and Global Quality applicable to role.
  • Ability to foster cross-functional cooperation.
  • Understanding of and ability to implement CI / HAPs initiatives.
  • Ensure Halal requirements are met in accordance with General Guidelines of Halal Assurance System LPPOM
  • MUI for applicable Medical device Products/Markets,

Problem Solving & Innovation

  • Ability to think strategically and use sound judgment.
  • A champion of change to improve systems and processes.
  • Play a key role during investigations into significant incidents that have resulted in non-conforming products or
  • compliance failures.
  • Demonstrated ability to effectively plan work and to manage projects.

Essential Qualifications & Skills we are looking for:

  • Higher degree level-Chemistry or Associated science.
  • Third Level Qualification preferred
  • 2-3years experience in a pharmaceutical / healthcare industry.
  • Understanding of appropriate directives, standards, policies and guidelines and ability to implement appropriately,

e.g.:

  • cGMP (CFR 210/211)
  • MDD (93/42/ EEC) / UK Medical Devices Regulation 2002 (SI/2002/618)
  • Medical Device Regulation 2017/745
  • EN ISO 13485: 2016
  • QMS Haleon Policies and Procedures
  • EU GMP
  • Pharmaceutical Affairs Law Japan
  • MHLW Ordinance No 169
  • MHLW Ordinance No 179
  • MHLW Ordinance No 2
  • CFR 820
  • Haleon Facility & Technical Process Guides
  • Understanding of relevant regulatory requirements for all markets.
  • Understanding of quality systems.
  • 2-3 years' experience in a pharmaceutical / healthcare industry.
  • Understanding of appropriate Directives, Standards, Quality Management Systems related to the manufacture of
  • Medical Device and Medicinal for required markets.
  • Ability to provide key input into management team decisions

Why Haleon?

None of us should ever feel like we are standing still. Instead, we want Haleon to be a place where we feel like we are always progressing.

Improving everyday health takes Dedication. Energy. Effort. So we look to reward your contribution with a benefits package that includes but not limited to:

  • Annual bonuses that reflect Haleon’s performance
  • – our philosophy to hybrid work and supporting individuals work/life balance
  • Childcare support – we offer enhanced maternity and paternity paid leave options for those important times as well as child care options
  • Life Insurance and Private Medical Package – with additional preventive healthcare services for employees to provide protection and piece of mind
  • Health and Wellbeing - programmes that take care of you physically and mentally
  • Development Opportunities - future-ready training, so your skills are always up to date within your role and company’s structure

Care to Join Us?

Apply now to hear more about this role and our journey changing the future of everyday health.

Care to join us. Find out what life at Haleon is really like 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. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

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