AddressFor Sartorius Stedim India Pvt. Ltd., we are looking for Quality Assurance Specialist to join our team in Bangalore. In this role, you will be responsible for quality assurance related activities pertaining to Validation Services in India besides review of validation protocols, reports, test raw data and other QMS documents. You will also be responsible for ensuring that Validation services meet the established standards set by the company. Sartorius Confidence® Validation Services provides services to customers in the (bio)pharmaceutical industry with focus on validation of filter and single-use applications.
What you will accomplish together with us:
Review of validation protocols, validation reports, test raw data, troubleshooting, quality controls and other operational reports to ensure that quality standards, efficiency and schedules are met.
Review/approve quality events, deviations, OOA and support in investigations and corrective actions.
Support the Laboratory Manage/Project Manager in continuous improvement of processes
Review processes and systems on an ongoing basis to determine opportunities for improvement.
Report inadequate processes and suggest suitable corrective and preventive actions.
Draft, revise, train, maintain and control operating procedures.
Support the Laboratory Manager in maintaining compliance to quality regulations as applicable.
Collaborate with Project management team and other internal stakeholders.
Ensure compliance with Sartorius quality standards.
Review customer needs and requirements with regard to aspects of QMS
Ensures that Validation Services is in compliance with local statutory, regulatory and safety requirements.
Preparing /representing Validation Services for external and internal audits.
To contribute for any other QMS/Safety pertaining activities.
What will convince us:
Master's degree in Life science /Pharma (e.g., MSc. Microbiology, M. Pharma etc.)
Minimum 5-8 Years related experience required.
Knowledge on ISO standards (e.g., 9001,14001), GDP, GLP, any other quality/ environment related regulations.
In-depth understanding of industry standards and company policies
Ability to prioritize and manage daily assignment.
Establish and maintain positive working relationships with all internal and external interfaces.
Ability to quickly assess assigned task requirements, identify potential challenges, and communicate effectively in order to expedite the successful execution of assigned work.
Experience with software application related to Laboratory operation/quality check/documentation procedure.
Ready to join Sartorius?
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application.
That’s What Your Colleagues Say
Andreas Norén, Head of Product Development Software Infrastructure & Operations
We are part of the solution in helping to develop novel cancer therapies, or maybe someday to find a cure to dementia. This is an incredible feeling.
Katja Herwig, POD Specialist, Germany
I work on many interesting projects and am in touch with many departments and international colleagues, which makes my job so diverse and exciting. Each day is completely different, but does provide one constant: I am part of the great Sartorius family and feel the enjoyment and openness of my colleagues. Sartorius brings together different cultures every day.
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At Sartorius, we believe that bringing together diverse perspectives is critical for our mission of simplifying progress in life sciences and bioprocessing so that new therapeutics can reach patients worldwide.
We therefore actively recruit and hire diverse talent from a mix of cultures, genders, age groups, physical and mental abilities, educational backgrounds, career paths and more, and do not tolerate any discrimination against applicants or employees.
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