Job type: Full-time

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Site Name: USA - Nebraska - Lincoln, Home Worker - GBR

Posted Date: Jun 9 2022

Sign-On Bonus $2,000

Are you looking for an opportunity to manage pharmacopoeial processes and work as part of a global organization? If so, this Quality Manager - Pharmacopoeia role may be right for you.

As the Quality Manager - Pharmacopoeia you will support quality activities and oversight within AS&T to ensure process compliance with company standards and regulatory agencies’ requirements.

Pharmacopoeia Compliance Quality System Support

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
  • Lead and publish internal pharmacopoeial reviews and intelligence communication.
  • Provide pharmacopoeial process training where needed.
  • Participate in pharmacopoeial-related external events and trainings.
  • Technical support for monograph implementation and troubleshooting.
  • Act as a central point of communication with pharmacopoeis.
  • Assist in the maintenance of compendial information storage/tracking process.
Maintain knowledge and understanding of cGMPs, and any additional training requirements for assigned tasks.

Secondary Responsibilities
  • Quality review & approval of GMP documents to ensure requirements are met.
  • Provide quality oversight and guidance for AS&T activities, ensuring compliance to local procedures and cGMPs.
  • Identify, lead and/or support implementation of continuous improvement opportunities.
  • Adhere to all safety guidelines and procedures.
  • Perform additional tasks as assigned.
Quality Responsibilities
  • Adhere to all Quality Compliance standards.
  • Adhere to QMS policy and regulatory requirements.
Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor’s degree in science or a relevant field (BS).
  • 4+ years of experience in a highly regulated industry.
Preferred Qualifications

If you have the following characteristics, it would be a plus:
  • Experience with compendial compliance, analytical chemistry, cGMP and method validation.
  • Knowledge of cGxPs and regulatory requirements.
  • Strong working knowledge of pharmaceutical processes, analytical testing, method development and validation.
  • Ability to manage, organize and track large volumes of information for clear communicating to a global organization.
  • Knowledge of compendial testing in a QC environment.
  • Understanding of pharmacopoeial requirements for license to operate.
Why Consumer Healthcare?

Right now, we’re on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We’re doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year – over a billion and a half of them – and it goes beyond products. It’s about truly helping people manage their health proactively in different ways as consumer needs evolve.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

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

Diversity, Equity and Inclusion

In Consumer Healthcare 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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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, GSK may be required to capture and report expenses GSK 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 GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

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Deadline: 19-07-2024

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