MAHESH UNNAVA

• Developed and implemented comprehensive testing strategies to enhance product quality and reliability.
• Led cross-functional teams in identifying process inefficiencies and driving corrective actions.
• Conducted thorough reviews of test plans, ensuring alignment with specifications and compliance standards.
• Mentored junior QA staff, fostering skill development and promoting best practices within the team.
• Analyzed defect trends to inform management decisions and prioritize resource allocation effectively.
• Managed risk effectively by proactively addressing potential issues before they became critical problems.

• Self-motivated, with a strong sense of personal responsibility.
• Worked effectively in fast-paced environments.
• Skilled at working independently and collaboratively in a team environment.
• Proven ability to learn quickly and adapt to new situations.
• Excellent communication skills, both verbal and written.
• Worked well in a team setting, providing support and guidance.
• Worked flexible hours across night, weekend, and holiday shifts.
• Managed time efficiently in order to complete all tasks within deadlines.

• Ensured compliance with FDA 21 CFR Part 820 and ISO 13485 by maintaining and supporting the Quality Management System (QMS) during company transition.
• Conducted thorough DHR reviews and approved batch records for timely product release, ensuring documentation accuracy and traceability.
• Investigated nonconformances, authored NCRs, and supported CAPA processes, including root cause analysis and effectiveness checks.
• Participated in internal audits and supported successful FDA and ISO inspections, preparing documentation and audit responses.
• Reviewed and routed Engineering Change Orders (ECOs), SOPs, and work instructions to maintain document control and QMS integrity.
• Performed incoming inspection support, verifying raw material quality and assisting in supplier corrective actions (SCARs).
• Delivered GMP training to production staff and contributed to quality awareness and audit readiness across departments.
• Supported continuous improvement initiatives, streamlining DHR workflows and reducing review cycle time.
• Collaborated with cross-functional teams to ensure regulatory alignment, manufacturing compliance, and supplier performance.

• Interpreted engineering drawings and blueprints to identify inspection points and ensure compliance with product specifications.
• Utilized advanced tools including micrometers, calipers, video measuring equipment, Lloyd materials testers, and pin gauges for visual, dimensional, functional, and destructive testing.
• Performed functional tests such as pull, peel, burst, and penetration testing to validate device integrity.
• Generated Certificates of Conformance (COC) for approved materials prior to release.
• Conducted final inspections on packaged materials to verify shipping documentation and product labeling accuracy.
• Released inspected materials from Pending QA Inspection to the packaging area after approval and COC generation.

• Knowledge of cGMP Regulations: Familiarity with current Good Manufacturing Practices (cGMP) guidelines and regulations specific to the nutraceutical industry
• Proficiency in Quality Assurance Procedures: Ability to interpret and implement quality assurance standards, SOPs, and testing protocols.
• Inspection and Sampling Expertise: Skill in inspecting incoming raw materials, in-process, and finished products for conformance to specifications
• Data Management and Documentation: Competency in maintaining accurate records, creating/modifying GMP documentation, and archiving quality-related information
• Analytical Problem-Solving: Capability to analyse deviations, investigate root causes, and implement corrective/preventive actions
• Regulatory Compliance: Understanding of relevant laws, regulations, and industry standards (e.g., FDA, ISO 17025) applicable to nutraceutical manufacturing
• Collaboration and Training: Ability to work cross-functionally, provide GMP training, and support quality initiatives

• Oversaw operations and provided corrective feedback to achieve daily and long-term goals.
• Strengthened client relationships with regular communication, timely project delivery, and high-quality services.
• Increased overall company performance by implementing strategic management initiatives and streamlining operations.
• Developed comprehensive business plans, outlining long-term goals and actionable steps toward success.