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Quality Control Analyst - Analytical Lab
Date: Apr 15, 2024
Location:
Haarlem, Netherlands, Other/Not Applicable, 2031
Company: Teva Pharmaceuticals
Job Id: 55306
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
As a Quality Control Analyst, you'll be responsible for ensuring the quality and compliance of our pharmaceutical products. Your key duties will include conducting detailed analyses, implementing new/updating test methods, and ensuring adherence to national and international quality standards such as cGXP, pharmacopoeia guidelines, and Teva Global standards.
Next to that you will identify deviations, investigate root causes, and proposing corrective actions to uphold product quality and regulatory compliance.
Will you be part of our Compliance, Stability and Investigations team?
How you’ll spend your day
Execute the implementation of and compliance with national and international quality standards (cGXP), pharmacopoeial guidelines and Teva Global standards
Timely implementation of validated Analytical methods.
Execute the review and implementation of Teva standards and procedures at the department.
Maintain adherence to corporate policies and appropriate regulations through actions and decisions.
Initiates corrective action as soon as deficiency is identified; completes checklist and other information sheets required and coordinates on-site inspection of sections for which responsible.
Write assessments, study protocols and reports as part of failure investigations or method updates, validations and/or verifications.
Testing and evaluation of quality of active ingredients and drug products throughout manufacturing process and during shelf life of the drug product (stability testing).
Maintain quality at the lab in accordance with site SOP's, regulatory guidelines and cGXP compliance requirements.
Participate in the change controlled quality management system for changes, deviations and out of specification results.
Actively participate in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions.
Execute all work according to high standards of quality at the lab through managing and continuously improving the effectiveness of laboratory quality processes and systems.
Preparation of documents that report the results of own lab work.
Give support during regulatory and compliance audits.
Your experience and qualifications
HLO+ (Bachelor's degree) in chemistry with several years of experience in a similar position in the pharmaceutical industry.
A strong analytical oriented mindset.
A minimum of 3 years of experience with chemical analysis techniques such as liquid and gas chromatography, particle size testing and water content testing in a cGXP environment.
Knowledge of and familiarity with relevant regulatory guidance's such as:
Appropriate ICH Guidelines.
Regulatory Agency/lndustry guidance's and Pharmacopeia Guidance's and Requirements including local regulatory requirements.
A good knowledge of chromatographic and other instruments operation and techniques.
Experience in analytical method development and validation.
Knowledge of Pharmaceutical quality systems (Trackwise).
Experience & exposure to work in regulatory environment as well as Regulatory Audit like EU cGMP inspection, US-FDA, ANVISA.
Ability to collaborate with in- and external team to manage a successful inspection and provide timely and thorough responses to the regulatory authority.
Experience in protocol and report writing.
Good knowledge of English language (verbal and in writing) is mandatory.
Good knowledge of Dutch language (verbal and in writing) is preferred.
Strong can-do mentality.
Result oriented team player.
Contact person
Ivo Huijskens - Senior Recruiter Benelux & Nordics
Reports To
Group Leader CSI
Pre employment screening
Teva will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran