Sampath Enukonda

+1-215-***-****, ad4bam@r.postjobfree.com

* ****

● A seasoned professional with 15 years of dedicated experience, currently serving as the Manager of Quality Assurance at Appco Pharma.

● Specialized in the pharmaceutical, biotech, and oral solid dose (OSD) manufacturing sectors.

● I bring extensive expertise in Quality Assurance, Quality Management Systems, Audit and Compliance, Sterility Assurance Level (SAL), Aseptic Manufacturing, and advanced Microbiological techniques.

● My extensive background includes managing regulatory audits and responses for esteemed organizations, including USFDA, EUROPE, INFARMED, MHRA, ANVISA, WHO, EU cGMP, TGA, MCC, and DCGI, among others. Eager to contribute my skills and experience in a leadership role within a reputable organization. Preferred Role:

Seeking a vertical shift within an organization of high regard, with a focus on the lead position in quality assurance. KEY ACHIEVEMENTS:

Professional Summary:

An experienced leader in Quality Management Systems (QMS) with a strong technical background. Proven track record in ensuring adherence to QMS, extensive knowledge of Quality Assurance, and expertise in various aspects of contract manufacturing. Skilled in ANDA documentation support, managing finished product releases, and regulatory audit preparedness.

● Leadership and Team Management: Managed quality assurance teams, providing leadership and technical support.

● Quality Management Systems (QMS): Demonstrated expertise in QMS, including Deviations (Incidents), Investigations, CAPA, Root cause analysis, change controls, Risk assessments, Gap assessments, Impact assessment, Subject Matter Expert (SME) in Microbiological out-of-limits (OOL), out of specifications (OOS), Out of Trend (OOT), etc.

● Audit and Compliance: Successfully conducted external and internal (self-inspection) audits in line with current regulatory requirements. Successfully managed regulatory audits, and ensured readiness for inspections. Including addressing responses and ensuring compliance

Proficient in vendor qualifications (Management) and Factory Acceptance Test (FAT).

● Documentation and Protocols: Expertise in the preparation and review of SOPs, STPs, Protocols, Summaries, and Specifications. Proficient in protocol preparation and participation in Media Fill Monitoring/simulation, Air Flow study visualization study review.

● Sterility Assurance: Specialized in Sterility Assurance Level (SAL), including aseptic techniques, aseptic gowning qualifications, and sterilization validation techniques (moist heat, dry heat, and VHP-vapor phase hydrogen peroxide).

● Computer System Validations (CSV) and Stability Management: Proficient in CSV and effective management of stability programs.

● Training and Education: Skilled in imparting training on Aseptic Processing behavior, Microbiological monitoring, and Personnel hygiene. Microbiological techniques and validations. Proficient in collaborating with regulatory consultants to enhance quality systems, including those from Quantic, Lachman, NSF, and, Meridian consultant groups.

● Microbiology: Possessing a strong proficiency in microbiological techniques

● Manufacturing Expertise: Demonstrated skills in Acceptable Quality Limits (AQL), Blending, compression, Encapsulation, and coating of Tablets and capsules.

● Software Proficiency: Sound knowledge of 21 CFR compliance software, including MODA (Environmental Monitoring and Facility Pro), TrackWise, Caliber QMS, and Master Control. Sampath Enukonda

+1-215-***-****, ad4bam@r.postjobfree.com

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CAREER SUMMARY

1. Currently working as a Manager in Appco Pharma, from June 2020 in a Quality Assurance department. 2. Worked with Penn Life Sciences from October 2018 to March 2020. 3. : Worked with Aurobindo Pharma, as an Assistant Manager from Aug 2015 to September 2018(QA & Microbiology department).

4. : Worked with Mylan Pharmaceutical, as a Senior Executive from Aug 2014 to July 2015. 5. : Worked with Biological E. Limited (Biotech Company), as an Assistant Manager from Feb 2010 –Aug 2014.

6. : Worked with Bharat Biotech International, as a Junior Executive from 2006 Dec - 2010 Jan. PRESENT JOB AND RESPONSIBILITIES

● Department: Quality Assurance.

● Employer: Appco Pharma LLC.

● Work location: 262 Old New Brunswick Rd, Piscataway, NJ 08854 USA Responsibilities:

● Leadership in the Quality Assurance Department: Spearheaded the Quality Assurance Department, overseeing a team of professionals to ensure product quality and compliance.

● Strategic Product Planning and Release: Orchestrated the strategic planning and flawless release of drug products, maintaining rigorous quality standards and regulatory compliance.

● Comprehensive Investigation Management: Proficiently prepared, reviewed, and approved reports on market complaints, deviations, and CAPA actions, validating their effectiveness.

● Quality Management Documentation Expertise: Meticulously reviewed and endorsed critical quality management documents, including Change Controls, SOPs, validation protocols, and risk assessments.

● Regulatory and Customer Audit Leadership: Held responsibility for regulatory and customer audit preparedness, ensuring seamless compliance with industry regulations.

● Strategic Collaboration with Regulatory Affairs: Collaborated seamlessly with the Regulatory Affairs department, providing instrumental support for ANDA-related documentation.

● Robust cGMP and Documentation Compliance: Pioneered efforts to ensure unwavering adherence to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (cGMP).

● Regulatory Training and Alignment: Delivered impactful training sessions to both the team and cross- functional units, aligning them with the latest regulatory standards, including ALCOA principles.

● Mastery of Quality Risk Management: Proficiently managed Quality Risk Management (QRM) initiatives and conducted thorough Annual Product Quality Reviews (APQR).

● Responsive Customer and Regulatory Interface: Swiftly collaborated to address customer and regulatory inquiries in strict accordance with cGMP and USFDA requirements.

● Exhibit Batch and Validation Coordination: Expertly reviewed and coordinated Exhibit batches and Process Validation activities, meeting rigorous regulatory requirements.

● Precise Oversight of Manufacturing Processes: Implemented rigorous oversight, including Acceptable Quality Limits (AQL), in processes such as blending, compression, encapsulation, and coating of tablets and capsules.

● Meticulous OOL and OOS Investigations: Conscientiously managed Out-of-level (OOL) and out-of- specification (OOS) investigations to uphold stringent quality standards.

● Thorough CSV (21 CFR Part 11) Expertise: Successfully prepared and reviewed Computer System Validation

(CSV) assessments, ensuring compliance with 21 CFR Part 11 and Good Practice (GxP) standards. Sampath Enukonda

+1-215-***-****, ad4bam@r.postjobfree.com

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TRAINING PROGRAMS

● Trained on the Investigation Excellence program conducted by Meridian consultants.

● Trained on Visual air flow studies evaluation.

● Training on GMP for Sterile products manufacturing, Quality Management Systems, Structure problem workshop, and Risk-Based Decision Making by NSF, UK.

● Training on Cleanroom behavior, BET Validation, Aseptic Training, Filter Validation, Method validation, Process of Approving Generic Drugs, Auditing Skills Etc. at Mylan Pharmaceutical Limited Ltd.

● Qualified internal Auditor and GMP Trainer

EDUCATIONAL PROFILE

● Master of Science, in 2006.

● Bachelor of Science, in 2004.

PERSONAL DETAILS

ADDRESS: 15 Bristol Dr, North Brunswick, NJ-08902 USA.

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