BPRR-Specialist (m/w/d) in der Pharmaproduktion PS1/2
Apply locations Penzberg | Full time | Posted yesterday | Job requisition ID 202504-110241
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The Position
Department
As part of the production team in Penzberg, our goal is to manufacture medicines for patients worldwide. In a lean production environment, we are committed to delivering outstanding products and continuously optimizing our processes to increase benefits for our patients.
Your Team
We are a team of about 16 professionals in pharmaceutical production in Penzberg, with diverse backgrounds, working on purification of products from clinical phase 3 onwards. We collaborate closely with fermentation, downstream filling, buffer preparation, MSAT, quality, and technical teams. We are proud to supply medicines worldwide from here, working with passion and a spirit of continuous improvement based on lean methodology.
Your Role
You will work across the entire manufacturing process of production lines 1 and 2 within a team of approximately 15 BPRR staff and two supervisors, responsible for the complete BPRR process.
About us
We are seeking YOU as a Batch Record Reviewer (BPRR). In this role, you will strengthen our department with your structured and transparent working style, helping to maintain and improve quality. You will represent the batch record confidently in inspections in both English and German.
Your Responsibilities
* Ensure timely review of batch production records (BPRR) in coordination with relevant interfaces.
* Review key steps such as ATR checks, trend analyses, and validated reports.
* Participate in meetings, daily huddles, and internal discussions, actively contributing topics.
* Initiate and handle complex deviations and investigations in collaboration with relevant departments.
* Participate in triages and actively contribute to problem-solving.
* Prepare and participate in audits as SME for BPR review of product approaches.
* Coach colleagues on GMP/GDP/Technical Writing.
* Review and revise documentation related to BPRR, including checklists and regulations.
What You Should Know
* Work environment includes at least 50% in a cleanroom, adhering strictly to GMP, safety, environmental, and hygiene standards.
Qualifications
* Completed technical or scientific education (Technician or university degree).
* Experience in API production or quality assurance in GMP environment.
* Proactive, detail-oriented, and compliant with guidelines.
* Ability to extract and review GMP documentation and data.
* Collaborative, team-oriented, and independent working style.
* Open to change and actively involved in process improvements.
* Basic IT skills, including SAP knowledge.
* Good English and fluent German skills.
Competencies
* Continuous improvement mindset.
* Openness to change, innovative thinking, and big-picture focus.
* Structured, responsible, and communicative approach.
* Curious, eager to learn, and persistent.
* Empathetic and skilled in interpersonal interactions.
This position is limited to two years.
We look forward to your application!
Application Documents
Please submit an up-to-date CV. A cover letter is optional. Note that no additional documents can be added after submission.
Contact Us
Need support? Check our FAQs at https://careers.roche.com/global/en/faq.
About Roche
We are committed to science and healthcare, with over 100,000 employees worldwide. Our goal is to deliver innovative healthcare solutions that make a global impact. Join us in building a healthier future.
Roche is an Equal Opportunity Employer.
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