Reviewer Production Documentation

Date: Aug 30, 2024

Location:

Haarlem, Netherlands, 2031

Company: Teva Pharmaceuticals

Job Id: 57920

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

We are looking for a meticulous Reviewer Production Documentation to join our team. In this role, you will ensure the accuracy, completeness, and compliance of all documentation throughout the drug manufacturing process. Stationed in the production department, you will work closely with operators and collaborate with various departments, including Parenterals, Quality Assurance, and Packaging. Your responsibilities will include guiding operators in proper documentation practices according to ALCOA++ principles, compiling and organizing relevant documents, reviewing BMRs/CVPs for completeness, and driving continuous improvements in the documentation process. This role is essential in maintaining the highest standards of compliance and quality in our production operations.

How you’ll spend your day

• Provide real-time guidance and support to operators during production, ensuring that they complete Batch Manufacturing Records (BMR) and Cleaning Validation Protocols (CVP) according to ALCOA++ principles.

• Gather and meticulously organize all necessary documentation related to each batch, ensuring a complete and traceable BMR/CVP.

• Conduct thorough reviews of BMRs and CVPs immediately after batch production to confirm accuracy, completeness, and adherence to regulatory standards.

• Identify and address any discrepancies, missing information, or unclear documentation by collaborating with operators and other stakeholders to rectify issues promptly.

• Oversee and coordinate the entire BMR/CVP review process, ensuring timely completion and submission of all records to Quality Assurance.

• Engage in regular meetings with stakeholders across various departments to discuss the progress and alignment of the BMR/CVP review cycle.

• Contribute to the ongoing enhancement of the BMR/CVP review process by proposing and implementing improvements that streamline documentation practices and increase compliance.

• Facilitate training sessions for operators on GMP guidelines and best practices for completing BMRs and CVPs in line with ALCOA principles, fostering a culture of accuracy and compliance.

Your experience and qualifications

• Knowledge of GMP guidelines and ALCOA principles.

• Experience with quality management systems like Trackwise.

• Familiarity with BMR/CVP processes in pharmaceutical manufacturing.

• 2-4 years of experience as an operator or documentation specialist in a pharmaceutical setting preferred.

• Experience with MES and SAP is a plus.

Contact person

Aleksa Honcharenko - Recruiter - EMEA

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