SRIKANTH TATIKONDA
Senior Quality Assurance Manager
Summary
Boasting more than a decade of experience in the Pharmaceutical industry, with expertise in Audit and compliance, Corporate Quality, Site Quality, IPQA, Batch release and Contract manufacturing (CMO) quality functions. . Demonstrated a successful history of managing CMO and vendor qualification and management activities, conducting audits for Various formulation and API, packaging materials vendors. Possessing extensive knowledge of regulatory requirements and a proactive approach to ensure Operational compliance through the use of guidance and external sources. Proficient in conducting self-inspections, facilitating management review meetings, and leading site investigations, making substantial contributions to ensure site readiness for regulatory audits.
Overview
13
13
years of professional experience
2
2
Certifications
Work History
Senior QA Manager
Rising Pharmaceuticals
06.2024 - Current
- Oversight of CMO/TPM quality for associated Suppliers, Planning and Execution of CMO/Supplier audits, service providers and Contract testing laboratories Qualification activities and CAPA management, .
- Conduct on-site and remote audits of CMOs, GxP and Health Regulated Third Party vendors to ensure compliance with regulations and company policies
- Provide QA and Technical Support to Third Party Manufacturers (TPM) and Contract Manufacturer Organizations (CMO), Affiliates, and other Stakeholders.
- Project plan preparation and implementation for vendor qualification and service providers qualification for new products introductions at site and CMOs.
- Involvement in and approval of changes to supplier qualification and certification status, supplier change management and maintenance of associated quality systems and documentation.
- Market complaints investigation and for-cause audits.
- Provided regular progress reports to stakeholders, highlighting key achievements, risks, mitigation plans, and other relevant updates.
Manager- Corporate QA & Compliance
Biological E Limited
8 2019 - 05.2024
- Scheduling and conducting self-inspections within defined time frames and reviewing self-inspection reports and relevant documents
- Preparing Management Review Meetings (Site Quality Council Meetings) presentations and coordinating for their action plan implementation
- Managing vendor qualification and related activities, including vendor qualification and re-qualification for various materials and service providers
- Conducting audits for formulation, CMO, Service providers, contract testing labs and API sites to ensure compliance with cGMP requirements
- Drafting of Quality and Technical agreements (QTA) with vendors and customers
- Reviewing and approving investigations of manufacturing process, failures, excursions, out-of-specification results, and market complaints
- Ongoing preparation and review of Annual Product Quality Review (APQR) reports
- Visiting the shop floor to ensure compliance with established practices, procedures, and current regulatory requirements, GxP Assessment, and related documents
- Preparing responses to observations received from customer and regulatory audits, ensuring timely closure of regulatory commitments and audit compliance CAPAs
- Project plan preparation and implementation for vendor qualification and service provider's qualification for new products introductions at site and CMOs
- Participating as a member in site investigations and audit readiness teams, contributing significantly to site readiness for USFDA, MHRA/EMA, ANVISA, etc audits.
- Accomplished multiple tasks within established timeframes.
Asst Manager- Global Quality Operations
Mylan Laboratories Limited
08.2016 - 08.2019
- Having exposure to dealing with multiple stakeholders across the globe in regulatory environment
- Monitoring of Quality Management System operational business in compliance with cGMP regulatory requirements and the Mylan Pharma Quality Manual and Policies
- Monitoring contract manufacturing sites' quality management activities related to Change control, deviations, CAPAs review, and approval
- Review batch records and provide shipping authorization and release of batches upon satisfactory review outcome
- Perform Product Quality service operations like product complaints, product deviations, product change requests, product release, product quality review, GMP documentation review, and approval
- Review & Approve annual product quality reports for CMO sites
- Overall responsibility for the Quality of products manufactured following GMP standards at the Manufacturing site
- Monitor the site GMP and communicate with Site Quality for compliance
- Manage all QMS activities from product development to till product lifecycle management
- Providing Quality support for product site transfer activities
- Investigated manufacturing process, facility, and equipment issues, ensuring timely closure of the same within established timelines.
Executive- Quality Assurance
Hospira (Pfizer) Healthcare Limited
04.2013 - 08.2016
- Conducted IPQA activities, including line clearances, shop floor compliance, sampling, and in-process checks at various stages of injectable drug product manufacturing
- Reviewed BHR records (BMR and BPR), media fill records, and coordinated the release of finished products in accordance with established procedures
- Participated in the Procedure Vs Practices module and conducted SOP gap assessments for all aseptic manufacturing and quality operations
- Participated in preparing the site for regulatory inspections by entities such as USFDA, UK MHRA, ANVISA Brazil, TGA, MCC South Africa, WHO, and internal audits
- Participated in Site remediation activities in response to regulatory warning letters.
Jr. Executive- QA
Celon laboratories. Ltd.
11.2011 - 04.2013
- Conducted activities such as line clearance, material verification, startup checks, and in-process checks in accordance with the Batch Manufacturing Record
- Reviewed executed batch records and ensured product reconciliation at each stage of production activity
- Prepared media fill batch records, trended interventions, planned and executed media fill protocols and reports
- Supervised and executed aseptic process simulations and media fills.
Education
B.Pharmacy - Pharmacy
Rajiv Gandhi University
M.Pharmacy -
Annamalai University
Skills
Quality Assurance and Management Systems
Certification
Certified Lean Six Sigma green Belt
Auditsexposure
- Audits performed for various dosage forms (FDF/API) and packing materials vendors around the globe.
- Participated in 10+ USFDA audits including medical devices audit by UDFDA conducted in October 2021, November 2022, and January-February 2023 at Biological E Limited, 2013, September 2015 and April 2016 (Joint regulatory audit) years at Hospira and Pfizer healthcare India Pvt. Ltd.
- Participated in 4+ EU (MHRA, SUKL- Czech Republic, etc) audits held in October 2023 and Jan 2024 at Biological E Limited, Involved in TGA audit conducted in October 2014 at Hospira Healthcare (India) Pvt. Ltd.
- Participated in various global customer audits.
- Contributed to compliance exercises for addressing observations from audits conducted by various regulatory agencies.
Achievements
- honored with "The BE STAR" award for a full two years in 2021 and 2022, in recognition of consistent excellence and performance that went above and beyond expectations.
- awarded as certified MQA for batch release authorization upon FDA warning letter remediation at Pfizer by Quintiles.
- successfully established corporate consolidated SOPs in the allotted period after the creation of the new CQA department.
- USFDA warning letter site activities resumption and implementation of procedures upon takeover by BE.
- Effective data integrity procedures are being implemented in associated CMOs as part of Myaln's global initiative.
Languages
English
Hindi
Telugu
Tamil
kannnada
Timeline
Senior QA Manager
Rising Pharmaceuticals
06.2024 - Current
Asst Manager- Global Quality Operations
Mylan Laboratories Limited
08.2016 - 08.2019
Executive- Quality Assurance
Hospira (Pfizer) Healthcare Limited
04.2013 - 08.2016
Jr. Executive- QA
Celon laboratories. Ltd.
11.2011 - 04.2013
Manager- Corporate QA & Compliance
Biological E Limited
8 2019 - 05.2024
B.Pharmacy - Pharmacy
Rajiv Gandhi University
M.Pharmacy -
Annamalai University
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