Sartorius
Location
Bangalore | India
Job description
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:
Masters 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.
Job tags
Salary