Pavan Bandaru
Audit Manager, Regulatory Affairs & Compliance at Aldevron | Master’s in Engineering Management
- Role
- Audit Manager at Aldevron
- Location
- Fargo, ND, US
- LinkedIn followers
- 500 followers
About Pavan Bandaru
Engineering professional with Master\'s degree, extensive experience, and proven technical proficiency in medical device & life sciences industry (ISO 13485, 21CFR 820, ICH Q7, Q9 & Q10) supporting New Product Development, Lead internal, external and FDA audits, developing manufacturing processes, DHF, DMR and DHR, Lean Manufacturing, Quality Engineering, CAPA administration, NCMR, Risk Management, Evaluating materials, Supplier Quality Management and Statistical Analysis. Works independently, responsible and self-motivated to learn innovative technologies.I have enjoyed years of experience and opportunities in engineering which have been instrumental in equipping me with the knowledge and providing me with the opportunity to develop the skills necessary to succeed in the quality engineering profession.
Experience
Audit Manager
Jun 2024 — Present · Fargo, ND, US
Manage and host External Client audits, FDA, Regulatory/Notified bodies to ensure that audit needs and expectations are met and that Aldevron is approved as a Supplier for both new and ongoing business with maintaining regulatory requirements.• Plan, lead, perform/host, and closeout external client audits.• Present audit observations and other metrics to site leadership in recurring Review Boards.• Writes, assembles, reviews, and seek approval of audit responses by management before submitting to any client. • Ensure audit responses meet all applicable External Standards and Regulations as well as Aldevron Quality System requirements.• Track & Trend audit observations, Track Right First Time percentage and present to management on a continual basis.• Participated in Government of Upper Bavaria audit that resulted in successful Aldevron certification as GMP compliance Manufacturer. • Identifies compliance risks to current regulations and guides the internal teams in planning and execution of Quality System improvements.• Uses current client audit observation trends to identify potential compliance risks or opportunities for improvement in the Aldevron Quality System.• Participate in corporate audits as needed.
Education
Trine University
Master's degree, Engineering Management
Bhashyam College of Education
High school, Maths, physics and chemistry
GITAM Deemed University
Bachelor's degree, Mechanical Engineering
Sri Chaitanya College of Education
Board of intermediate, Maths, physics and chemistry
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