Gajanan Shivajirav Sirsale
Sr. Manager Quality Control & Audit Compliance.
Indore
Summary
Results-driven Senior Manager Quality Control with 20 years in pharmaceutical QC, focusing on Quality Management Systems, GLP, and regulatory compliance. Leads quality operations with expertise in formulation testing, method validation, and QMS implementation. Skilled in chromatography and regulatory audits, ensuring adherence to international quality standards through comprehensive training and effective quality assurance strategies.
Overview
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1
Language
2
2
Certifications
21
21
years of professional experience
Work History
Sr. Manager QC
Endo India Par Formulation
11.2023 - Current
- Directed comprehensive quality management systems (QMS) activities encompassing OOS, OOT, deviations, change controls, CAPA, LIR, and data integrity processes ensuring timely resolution and effective analysis of all records
- Ensured accurate packing of raw materials to meet quality standards, consumables, and water analysis sections to ensure adherence to approved specifications and procedures.
- Supported regulatory compliance through preparation for internal and external audits, coordination of audit responses, and facilitation of interactions with regulatory agencies including USFDA.
- Conducted gap assessments aligned with international regulations and guidelines, including EU Annex 11 and 21 CFR Part 11, while facilitating remediation activities.
- Directed and implemented computerized system validation (CSV) activities throughout full lifecycle (URS, FS, VP, IQ, OQ, PQ, VSR, FAT, SAT, DQ) ensuring compliance of laboratory computerized systems.
- Performed audit trail reviews and oversaw software upgrades for key laboratory systems including Empower 3.8.1 and ICDAS 3.1, ensuring validated state and data integrity.
- Contributed to LIMS implementation projects (paperless port-based file-based CDS) facilitating system configuration validation and integration into laboratory workflows
- Spearheaded laboratory investigations in collaboration with RRT and SMEs to execute root cause analysis, define appropriate CAPA, and verify CAPA effectiveness.
- Oversaw incident escalation and documentation processes, ensuring thorough investigations, accurate impact assessments, and implementation of effective preventive actions.
- Formulated, assessed, and sanctioned SOPs alongside controlled documents pertaining to QMS laboratory operations, CSV, and data integrity.
- Compiled periodic QMS trend reports and provided actionable insights to management, fostering continuous improvement initiatives.
- Developed and implemented training programs for laboratory personnel focusing on GLP data integrity, OOS investigations, and safety requirements.
- Oversaw daily laboratory operations including strategic planning and monitoring of testing activities to ensure efficient and compliant execution
- Managed instrument qualification and calibration schedules to maintain operational efficiency. Coordinated prompt resolution of equipment breakdowns, ensuring minimal downtime. Ensured readiness of analytical instruments for accurate data collection.
- Collaborated with vendors for selection, installation, and qualification of new laboratory instruments and software, ensuring alignment with user requirements and regulatory expectations.
- Evaluated project documents and facilitated implementation of new laboratory systems and software emphasizing validation data integrity and operational suitability.
- Contributed as key member of site response and remediation team for regulatory actions including USFDA warning letters, emphasizing data integrity remediation strategies.
- Developed strategies for cost-saving initiatives within quality control processes within quality control function by optimizing laboratory process systems and resource utilization.
- Facilitated favorable outcomes during unannounced US FDA audit by ensuring QMS robustness, laboratory compliance, and effective response to audit queries.
- Spearheaded major software infrastructure upgrades in qc, including Empower 3.8.1 stability chamber, IC-DAS 3.1, and Lab Advantage software implementation
- Implemented LIMS to transition QC laboratory operations to a paperless system.
Sr. Manager QC
Aurobindo Pharma Limited
06.2020 - 10.2023
- Assisted general manager in daily quality control laboratory operations, focusing on deviation investigations, change control management, and audit readiness.
- Executed activities across computerized system validation (csv) lifecycle including user requirement specifications, functional specifications, verification protocols, installation qualification, operational qualification, performance qualification, and validation summary report documentation and review
- Spearheaded implementation of LIMS and related paperless systems, conducting gap assessments of systems and SOPs while coordinating corrective actions.
- Streamlined IT quality system for compliance with EU Annex 11 and 21 CFR Part 11 through periodic evaluations and documentation control.
- Managed change controls and CAPA management including assessment, implementation follow-up, and verification of CAPA effectiveness
- Ensured compliance with CGMP and GLP standards through monthly audit trail assessments, event trending, and system security maintenance (user privileges, password policies)
- Directed instrument lifecycle management within QC laboratory, encompassing breakdown coordination, preventive maintenance, calibration, and qualification activities.
- Monitored inventory of chemical impurities, working standards, reference standards, and primary standards.
- Trained and guided new associates in quality control procedures, computerized systems, and safety practices, fostering strong quality and laboratory safety culture.
Sr. Manager QC
Micro Labs Limited
08.2015 - 06.2020
- Managed end-to-end OOS/OOE/OOT processes, ensuring timely logging, investigation, impact assessment, and escalation of critical stability failures or field alert-related events for compliant close-out
- Oversaw stability section, including planning stability samples, reviewing and approving stability protocols, summary sheets, and trend reports, and monitoring stability chambers to ensure compliance with defined conditions and requirements
- Ensured data integrity and computerized system compliance with EU Annex 11 and 21 CFR Part 11 through thorough gap assessments of systems and SOPs
- Directed periodic calibration and qualification (IQ OQ PQ) of laboratory instruments, ensuring risk assessment of equipment to maintain reliable and compliant analytical operations.
- Directed laboratory quality and compliance by trending laboratory errors, investigating out-of-calibration results, assessing potential failure impacts, and tracking CAPA closure and extension for prompt remediation.
- Spearheaded implementation of LIMS projects, including paperless initiatives and Port Base File Base CDS integration
- Evaluated analytical protocols and raw data for accuracy, completeness, and integrity, delivering data summaries and reports to facilitate management review and decision-making.
- Mentored, instructed, and shaped new associates in QC procedures, data integrity expectations, and documentation standards to uphold high levels of competence and compliance
QC Sr. Executive
Sandoz Private Ltd., Navi Mumbai
03.2010 - 08.2015
- Spearheaded OOS and OOT investigations, conducting thorough root cause analysis and implementing corrective and preventive actions to enhance QC laboratory processes.
- Analyzed laboratory errors to identify systemic weaknesses and support continuous improvement initiatives within QC function.
- Inspected and verified chromatographic data (HPLC GC) ensuring consistent adherence to regulatory and internal standards.
- Verified chromatographic data (HPLC, GC) to ensure adherence to regulatory and internal standards.
- Conducted periodic analysis and evaluation of laboratory errors to identify systemic weaknesses and enhance continuous improvement initiatives within QC function.
- Developed stability analytical protocols and facilitated compilation, review, and submission of drug product documentation for international regulatory authorities including USFDA and MHRA (UK).
- Monitored laboratory operations to ensure strict adherence to good laboratory practices (GLP).
- Designed and implemented training programs for QC associates on OOS investigation procedures, root cause analysis, and documentation practices.
- ensured strict adherence to good laboratory practices (glp), reinforcing robust documentation, data integrity, and standardized laboratory procedures
Management Staff QC
Okasa Pvt. Ltd.
09.2005 - 02.2010
- Analyzed in-process materials and finished products to improve quality control and inform release decisions
- Executed calibration of HPLC, GC, and associated laboratory instruments to guarantee accuracy and reliability of results.
- Operated analytical tools, including HPLC and GC, to ensure reliable testing outcomes.
- operated and maintained analytical tools like HPLC and GC following established protocols
- Documented analytical activities and results to ensure compliance with laboratory and quality standards.
Education
Master of Business Administration (M.B.A.) - General Institute (Correspondence)
Indian Institute of Advanced Management Training & Research (IIM)
Goa01-2008
Master of Science (M. Sc.) - Organic Chemistry
Dr. Babasaheb Ambedkar Marathwada University (Dr. B.A.M. University)
Aurangabad01-2005
Bachelor of Science (B. Sc.) - undefined
Dr. Babasaheb Ambedkar Marathwada University (Dr. B.A.M. University)
Aurangabad01-2003
Skills
QC lab leadership
QMS oversight
Regulatory compliance
CSV expertise
Root cause analysis
Laboratory management
Documentation training
Lab operations management
Project management
Laboratory compliance
QC lab setup
Accomplishments
- Successfully implemented significant cost-saving initiatives within the Quality Control department.
- Played a key role in achieving positive outcomes during a recent unannounced USFDA audit.
- Spearheaded major software infrastructure upgrades, including Empower 3.8.1, Stability chamber ICDAS 3.1, and the implementation of the Lab advantage software.
- Successfully implemented LIMS (Laboratory Information Management System) projects, transitioning towards paperless laboratory operations.
Certification
Diploma in Office Automation (D.O.A.)
Interests
Hobbies & Interests: Reading, listening to music, traveling, playing cricket, etc
Personal Strength
- Leadership and Soft Skills:
- Team Building & Leadership: Proven ability to build and lead high-performing teams, utilizing strong lateral leadership skills to foster collaboration and a culture of excellence.
- Project Management: Skilled in the effective planning, execution, and timely delivery of projects according to established timelines and goals.
- Adaptability & Collaboration: Demonstrated success working effectively within diverse, multicultural environments, emphasizing cross-functional collaboration and engagement.
- Employee Engagement: Expertise in motivating teams, setting clear expectations and goals, and empowering autonomy to drive engagement and results.
- Continuous Improvement Culture: A committed team member promoting a culture of continuous improvement, innovation, adaptability, feedback loops, and ongoing learning.
Training Program
- Culture of Excellence Program: Completed comprehensive training on the five key improvement areas:
- Right First Time Culture
- Focus on Good Catches
- Quality Training Program
- Electronic Data Review
- Quality Behaviors
- USP Seminar: Participated in the seminar: "Practical Applications of Chapter Residual Solvents."
- Agilent Academia Training: Completed a hands-on workshop and training course focused on "HPLC Method Development."
Award
Contamination Investigation Expertise: While at Sandoz Private Ltd (a Novartis Group company), made significant contributions to properly identifying contamination levels and conducting thorough, effective investigations to resolve issues and maintain product quality.
Declaration
I hereby declare that the above-furnished details are true and correct to the best of my knowledge and belief.
Timeline
Sr. Manager QC
Endo India Par Formulation
11.2023 - Current
Sr. Manager QC
Aurobindo Pharma Limited
06.2020 - 10.2023
Sr. Manager QC
Micro Labs Limited
08.2015 - 06.2020
QC Sr. Executive
Sandoz Private Ltd., Navi Mumbai
03.2010 - 08.2015
Management Staff QC
Okasa Pvt. Ltd.
09.2005 - 02.2010
Bachelor of Science (B. Sc.) - undefined
Dr. Babasaheb Ambedkar Marathwada University (Dr. B.A.M. University)
Master of Science (M. Sc.) - Organic Chemistry
Dr. Babasaheb Ambedkar Marathwada University (Dr. B.A.M. University)
Master of Business Administration (M.B.A.) - General Institute (Correspondence)
Indian Institute of Advanced Management Training & Research (IIM)