Quality Assurance Supply Chain

Sreenath Konanki

732-***-**** ***************@*****.*** Piscataway, NJ LinkedIn

SUMMARY

Accomplished professional with extensive experience in Quality Assurance domains. Expert in Quality systems for regulated markets, ensuring compliance and delivering high-quality results. Collaborative and skilled in working with interdisciplinary teams. History of success in Quality Assurance teams with expertise as functional Lead in QC domains. Strategic and solutions-driven, adept in maintaining an agile and adaptable work approach. Exceptional talent in the ability to produce innovative ideas and concepts to address the queries for regulated markets. With extensive experience in internal and external audits, I have represented the company in a range of regulatory inspections, including USFDA PAI, clinical audits, and cGMP audits, as well as customer and vendor audits.

SKILLS

Decision-Making

Problem-Solving

Expert in QUMAS, QAMS, SAP, ERP

Strong Knowledge on audits

Project Management

Exceptional communication

Strategic Planning

Expert in technical justifications reporting

EXPERIENCE

Amneal Pharmaceuticals - Piscataway, New Jersey June 2016 – Current

Associate Director - QA

Oversee all facets of quality assurance in the clinical and commercial manufacturing of prescription pharmaceutical products as the head of the QA department.

Provide expertise in GCP and GMP, supporting the development of the commercial supply chain and ensuring inspection readiness across operations.

Offer GCP and GMP leadership, supporting CMC, drug product, and supply chain/logistics operations, including GMP contract manufacturing activities.

Review and approve master batch records and executed batch records to ensure compliance with 21 CFR Parts 210, 211, and 820.

Establish and evaluate standard operating procedures (SOPs), ensuring alignment with current federal regulatory requirements and supporting corporate quality assurance initiatives.

Oversee product release and ensure overall quality compliance for the manufacturing and testing of pharmaceutical products, including clinical and commercial.

Ensure compliance with internal and external audit observations, collaborating with audit, inspection, and CAPA management teams within R&D quality.

Work closely with clinical study management teams to provide clinical compliance guidance, address identified issues and support continuous improvement initiatives.

Support the successful implementation of projects within budget and timeline constraints.

Execute global risk assessments as a subject matter expert for investigator site and vendor audit planning.

Foster a culture of collaboration with internal manufacturing teams and CMOs to ensure effective communication, facilitating compliance decisions for QA, cGMP, and GCP.

Apply risk analysis and mitigation strategies in compliance decision-making, capturing relevant metrics and reviewing them periodically to proactively identify potential issues and opportunities for improvement.

Assist with field alerts and recalls, managing the recall process, ensuring proper documentation, and archiving recall data.

Regulate equipment, facility, and utility qualifications, including URS, FAT, IQ, OQ, and PQ of manufacturing and analytical equipment.

Manage quality systems, including change controls, deviations, root cause analysis (RCA), and CAPAs, from product development through tech transfer to commercial manufacturing.

Oversee and coordinate FDA and other regulatory inspections, ensuring compliance with site activities and requirements.

Aurex Laboratories LLC - New Jersy Jan 2016 – May-2016

Senior Manager - QA

Led the QA department for the manufacturing of generic and OTC pharmaceutical products, ensuring compliance with regulatory standards.

Ensure adherence to 21 CFR Parts 210 and 211 compliances across manufacturing processes.

Conduct vendor audits focused on GMP activities to ensure quality and regulatory compliance.

Coordinate with various CROs involved in formulation development and bio studies, tracking project progress and ensuring compliance with relevant guidelines.

Oversee and manage the preparation of ANDA applications and FDA-required annual supplemental applications, conducting thorough reviews to ensure regulatory requirements are met.

Provide GCP and GMP expertise and QA support for the development of the commercial supply chain, ensuring ongoing inspection readiness.

Offer leadership in GCP and GMP QA, supporting CMC, drug product, and supply chain/logistics operations, including all GMP contract manufacturing activities.

Prepare, manage, and maintain regulatory submissions (e.g., ANDAs, CTDs, amendments, annual reports) in compliance with applicable regulations, ensuring practical, workable submission plans and adherence to timelines. Coordinate internal and external teams for authoring, reviewing, and finalization of submissions.

Interface with external regulatory groups (CROs, CMOs, partners, consultants) throughout the preparation, review, compilation, and submission of regulatory documents.

Track and monitor company progress toward fulfilling regulatory commitments, ensuring timely and accurate completion.

Contribute to local process improvements impacting Regulatory Affairs, Quality Assurance, and other departments.

Review and communicate evolving regulatory requirements, including US and international regulations and guidelines, to ensure ongoing compliance.

Author and review standard operating procedures (SOPs), ensuring they align with current regulatory requirements and support corporate quality assurance initiatives.

Oversee product release processes and manage market/customer complaints to ensure compliance and resolution.

Ensure overall quality compliance for the manufacturing and testing of drug products, supporting both clinical and commercial operations.

Formurex, Inc - Stockton, California April 2014 - Jan 2016

Manager - QA

Oversee GCP management for drug product manufacturing in Phase-1 clinical and preclinical trials, ensuring compliance with regulatory standards.

Provide GCP expertise and QA support for the development of the commercial supply chain, ensuring continuous inspection readiness.

Manage clinical projects, coordinating cross-functional teams to ensure timely and compliant execution of trials.

Support business development efforts, identifying opportunities and driving growth initiatives.

Ensure safety and waste management protocols are in place and adhered to, maintaining compliance with environmental and regulatory requirements.

Appco Pharmaceuticals Corp - Piscataway, New Jersey Oct 2013 -April 2014

Head - QA

Headed QA department for generic manufacturing.

To ensure 21 CFR part 210/211 compliance.

Project management for generic formulation development at various sites.

To coordinate with various CROs (Formulation development and bio studies) to track the projects and monitor the project compliance.

To coordinate with various Contract Manufacturing sites to comply with project requirements.

Develop and implement cGMP policies related to Validation management/assurance and compliance.

Equipment/facility/utility qualifications-URS, FAT, IQ, OQ and PQ of manufacturing and analytical equipment.

Vendor audits-API, Excipients, Packaging materials, CROs, CMOs, contract testing labs.

OTHER RELEVANT EXPERIENCE

Dy. Manager-QA Shantha Biotech Hyderabad, India April 2013 - Sep 2013

Asst. Manager-QA Natco Pharma Limited Hyderabad, India Sep 2009 - April 2013

Senior executive-IPQA Aurobindo Pharma Ltd Hyderabad, India Jan 2009 - Aug 2009

Executive- QA Biological E. Limited Hyderabad, India Feb 2007 - Jan 2009

Jr. Executive-QA Bharat Biotech Hyderabad, India Aug 2005 - Jan 2007

Microbiologist – QC Sai Parenterals Pvt Ltd., Hyderabad, India Aug 2001 - Mar 2003.

EDUCATION

Doctor of Philosophy (Ph.D.) in Biotechnology SK University, Anantapur, India. (2021)

Master of Science (M.Sc.) in Biotechnology Bharathidasan University, India (2009)

Master of Science (M.Sc.) in Microbiology SK University, Anantapur, India. (2005)

CAREER HIGHLIGHTS EXPERTISE

Building and leading high performing, motivated, engaged, and efficient teams

Extensive hands-on experience in the development and manufacturing of a wide range of dosage forms, including sterile injectables (sterile dry powders, small and large volume sterile formulations, BFS, PFS, lyophilized products, sterile inhalations, vaccines and biologics, oral solid dosages, oral liquids, topical and transdermal systems, metered-dose inhalers (MDIs), dry powder inhalers (DPIs), suppositories, medical devices as well as hormonal and potent drugs, with in-depth knowledge of regulatory and quality requirements.

Strong Experience in implementing pFMEA, Design Development Plan (DDP), Design Transfer, Design History Files (DHF) in compliance with 21 CFR Part 820.

Comprehensive and current knowledge of North American (FDA, Health Canada) and European (EU) regulatory requirements for GCPs and GMPs, relevant to both R&D and commercial manufacturing of drugs and finished pharmaceuticals. Well-versed in key regulations such as CFR Parts 820, 210, 211, 11, ICH guidelines, and EU Annexes 4 and 11

In-depth knowledge of quality systems, including CAPA, change controls, deviations, non-conformances, root cause analysis (RCA), market complaints, and the oversight of incoming materials and finished product laboratory testing. Proficient in managing bulk manufacturing and packaging processes, administering marketed product stability programs, and performing product trending and statistical analyses to ensure continuous quality and regulatory compliance.

Extensive experience in conducting internal and external audits, including representing the company during multiple regulatory inspections such as USFDA PAI, clinical audits, and cGMP audits, as well as customer and vendor audits.

Skilled in applying a risk-based approach and consistently leveraging Quality Risk Management principles to validate complex, customized computerized and non-computerized systems.

Skilled in coaching and mentoring new hires, consultants, and co-op students, delivering training and support to facilitate smooth onboarding and effective integration into the team.

Skilled in auditing API suppliers, manufacturers, CMOs, CROs, contract testing laboratories, clinical sites, and packaging material suppliers to ensure regulatory compliance and uphold stringent quality standards.

Skilled in Microbiological testing and investigation of Sterility Testing USP <71>, Bacterial Endotoxin Testing USP <85> (BET), Environmental Monitoring of clean rooms, Microbiological testing of non-sterile products USP <60>, <61> & <62>.

Creative and analytical with excellent problem-solving skills and troubleshooting aptitude.

Able to work in fast phase work environment and manage heavy workload and aggressive timelines, prioritize work under pressure.

References: Can be furnished upon request.

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