Summary
Overview
Work History
Education
Skills
Websites
Timeline
Generic
PRAJAKTA PARULEKAR

PRAJAKTA PARULEKAR

Pune

Summary

Experienced pharmaceutical professional with 15 years in the industry, showcasing adaptability and a proactive mindset. Recognized for strong work ethic and excellent communication abilities. Focused on supporting team dynamics and driving organizational success.

Overview

15
15
years of professional experience

Work History

Specialist-Quality-GQSS

MSD
Pune
04.2024 - Current
  • Analyzed vendor and external laboratory documentation associated with receipt and release of materials to confirm alignment with internal specifications and Pharmacopeia.
  • Oversee the receipt and release of all materials in SAP, ensuring the achievement of QC Right First Time and turnaround time KPIs.
  • Liaised with external groups to monitor material receipt and release progress.
    Collaborated with different sites by sharing skills and expertise for optimal outcomes.
  • Managed QMS processes for the GQSS team and participated in investigations to ensure compliance and efficiency.
  • Managed the timely closure of incidents, deviations, CAPAs, and effectiveness checks in SAP.
  • Conducted comprehensive training sessions for the team on the release process of incoming materials.
  • Facilitated compliance with audit and inspection requirements, ensuring departmental readiness.
    Contributed to internal and external audits, reinforcing adherence to regulatory standards.
  • Periodically assessed all relevant procedures in Veeva, for compliance with current practices and revised guidelines.

Deputy Manager (Quality and Compliance)

Syngene International Limited
Bangalore
03.2022 - 04.2024
  • Managed team of nine focused on Quality and Compliance measures (Lab and Audit).
  • Managed the QMS activities for GMP – Stability (DP & DS), in-process/intermediate, raw material, method validation, and special instruments. This includes reviewing the investigation of OOS, OOT, deviations, CAPAs, change controls, and customer complaints to ensure timely closure and release of materials.
  • Liaised with the clients regarding the way forward for critical investigations.
  • Implemented robust quality management system for laboratory and audit compliance.
  • Analyzed monthly metrics to support data-driven improvements.
    Oversaw project management and client interactions to maintain high operational standards.
  • Reviewed audit responses for submission to internal stakeholders and clients, regulatory surveillance activity, and performed self-inspections.
  • Led the phase-appropriate quality system activity for process simplification, which reduced the manual efforts by 40%.
  • Carried out periodic reviews of SOPs to ensure complete adherence to cGMP and cGLP.
  • Prepared and presented the monthly metrics for the team.
  • Worked on the annual budgeting for the department.

Assistant Manager (Corporate Quality)

Advanz Pharma
Mumbai
04.2018 - 03.2022
  • Quality, investigations, CMO and client management, Trackwise, CAPA, deviations, change management process, product quality review.
  • Handled 50 Contract Manufacturing Organizations (CMOs) for the commercial stability management program.
  • Guided the CMOs in identifying the root cause for QMS issues, and effectively conducted thorough investigations.
  • Monitored anomalies in specifications and trend results on stability testing.
  • Drafted the risk assessment and investigation report of the reported failures, in line with country-specific requirements.
  • Communicated risk assessment of outliers to regulatory agencies, including USFDA, MHRA, HPRA, and TGA.
  • Assessed the impact of QMS on marketed products and regulated market recalls, if required.
  • Evaluated the standard operating procedures (SOPs), recommended enhancements as needed, and ensured adherence to the established procedures.
  • Conducted proactive internal audits, as well as self-inspections.
  • Compiled monthly reports detailing department metrics
  • Incorporated serialization step in the market complaints process by collaborating with involved stakeholders
  • Performed the Product quality review.
  • Finalized risk assessments, justifications, expert statements, and RFI responses for regulatory submissions.

Research Associate in Quality

Perrigo Laboratories
Mumbai
05.2015 - 04.2018
  • Conducted registration stability analysis for Drug Substance and Drug Product.
  • Led CI project under 5S program to reduce time and movement in lab activities.
  • Participated in laboratory investigations for OOS and atypical results, drafting deviations and initiating CAPA.
  • Ensured timely closure of deviations by collaborating with Quality Assurance team.
  • Performed monthly laboratory audits through systematic rounds.
  • Drafted and revised Standard Operating Procedures to enhance compliance.
  • Contributed to successful USFDA audit preparation and execution.

Assistant Quality Control Officer

Johnson & Johnson
Mumbai
07.2010 - 04.2015
  • Conducted commercial stability analysis for diverse formulations, and performed instrument calibration.
  • Performed dissolution testing using UV and HPLC, including assay and impurity evaluations.
  • Executed physicochemical product testing, including viscosity assessments and other critical analyses.
  • Completed the yellow belt project under the TDDB initiative to enhance inventory management and reduce costs.
  • Served as 5S champion, promoting lean six sigma methodologies across operations.
  • Assisted the audit preparation team, ensuring compliance with US FDA and EMEA regulations.

Education

Bachelor of Pharmacy -

Dr. L. H. Hiranandani College, University of Mumbai
05.2010

Diploma of Pharmacy -

P. V. Polytechnic, S.N.D.T. Women’s University
05.2007

Skills

  • Software: TrackWise, ELIMS, SLIMS, Novatek, SAP, Veeva, MEDS, CLUE, Bud-E

Timeline

Specialist-Quality-GQSS

MSD
04.2024 - Current

Deputy Manager (Quality and Compliance)

Syngene International Limited
03.2022 - 04.2024

Assistant Manager (Corporate Quality)

Advanz Pharma
04.2018 - 03.2022

Research Associate in Quality

Perrigo Laboratories
05.2015 - 04.2018

Assistant Quality Control Officer

Johnson & Johnson
07.2010 - 04.2015

Bachelor of Pharmacy -

Dr. L. H. Hiranandani College, University of Mumbai

Diploma of Pharmacy -

P. V. Polytechnic, S.N.D.T. Women’s University

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