Sep 2023 – Sep 2024 · 1 yr · Pune, Maharashtra, India · On-site

Apr 2023 – Sep 2023 · 5 mos · Bengaluru, Karnataka, India · On-site

• Handled the Green field project for mAbs.

Jul 2022 – Apr 2023 · 9 mos

Dec 2019 – Jul 2022 · 2 yrs 7 mos

•  Certified Green Belt Holder.
• Lead, Operational Excellence Projects.
• Lead for evaluation and approval of Change Controls, Deviations, CAPA records and site specific documents (SOP, Protocols, and Reports).
•  To Certify batch records (eBMR) and associated analytical records before the certification of batch as “released”.
•  Review and approval of Process validation/Verification as well as cleaning validation/ verification protocols.
•  Continuous monitoring and improvement of RFT KPI for turn round time reduction in batch record review, certification and release.
•  Responsible for process oversight to ensure compliance of Drug Substance batches and on time batch release. Assessment of Product Quality Review reports and implementation of PQR recommendations.
•  SPOC for interaction with Cross Functional Team leads to support and facilitate the closure of discrepancies or issues (if any) related to batch processing.
•  To monitor Quality Metrics and KPI’s for continues improvement. (On time Deviation Closure, On time CAPA implementation, % CAPA effectiveness, reduction of Human Error and repeated deviations)
•  Lead for Gap assessment activities and associated Quality Risk Analysis, mitigations. Responsible for Gap assessment for regulatory requirement/audit observations and implementation of global CAPA.
•  To participate in the internal, external audits as an SME and supports to address the queries

Apr 2019 – Dec 2019 · 8 mos · Mumbai, Maharashtra, India

•  Oversight of Drug Substance manufacturing process (Microbial) for on time batch completion and release.
•  I was handling all internal audits as an auditee and as a co-auditee for external audits.
•  I was responsible for batch release into European markets by direct coordination with QP.
•  I was Trending batch review errors to increase the RFT of batch record review and on time release.
•  I was responsible for Gap assessment w.r.t. regulatory audit observations and implementation of global CAPA.
•  Managed all deviations, CAPA, Change Control and risk assessment documents for review and approvals.
•  I was responsible to coordinate with all key stake holders for periodical quality meetings to resolve issues, identify improvement plans and implementation pathway.

Feb 2018 – Mar 2019 · 1 yr 1 mo · Mumbai, Maharashtra, India

Aug 2016 – Feb 2018 · 1 yr 6 mos · Baddi

•  I was responsible for site QMS (Investigation, Change Control and CAPA).
•  Handled investigations, CAPA and Change Controls by using Trackwise software.
•  I was responsible for representing QMS data to external auditors.
•  I was responsible for approval of MFC, BMR, BFR and BPR.
•  I was handling CAPA Effectiveness check and Gap assessment studies.
•  Managed a team of 07 (Direct Reporting) for QMS and EBRM activities and ensuring skill enhancement of team members.
•  I was responsible for performing Risk Assessment for critical change implementation.
•  Handled the training of manufacturing team as per schedule and requirement.

Apr 2014 – Jul 2016 · 2 yrs 3 mos · Bengaluru Area, India

•  I was responsible for site Qualification and Validation activities.
•  Monitored batch execution at CMO for Drug Substance and Drug Product.
•  I was Involved in development and up gradation of QMS.
•  Conducted training on cGMP, GLP and Regulatory requirements.
•  Participated in the internal audits as well as participating in external audits. Responsible for closure of Non- Compliances
•  Participated in Technology Transfer activities of Drug Product to new mfg. site.
•  I was monitoring shop floor activities and closure of non-compliances on daily basis.
•  Handled the quality documents like Change Controls, Deviations and CAPA documents.
•  I was reviewing the BMR and BPR before batch release.

May 2011 – Apr 2014 · 2 yrs 11 mos · Bangalore

•  I was responsible for monitoring of the activities starting from material receipt to batch release in Loan license units.
•  Reviewed qualification documents of LL units (i.e. Equipment Qualifications, HVAC Qualifications, process validations) as and when required.
•  I was conducting Training programs at LL sites.
•  Supported for closure of market complaints.
•  I was ensuring the release of batches as per provided schedule.
•  Involved in preparation of APQR, Audit Compliance reports and RCA.
•  I was responsible for implementing the GMP requirements at LL sites.
•  I was reviewing the Change Controls, Deviations, Audit Reports, Analytical Reports (RM/PM/FP) and CAPA of LL sites related to Cipla products.
•  Reviewed Facility Microbial monitoring and, Water (WFI/PW/PS) trend documents.
•  I was responsible for Investigation and closure of Facility, Equipment and Utilities related Discrepancies.

Apr 2009 – Apr 2011 · 2 yrs

•  I was responsible for monitoring of the activities starting from material receipt to batch release in Loan license units.
•  Reviewed qualification documents of LL units (i.e. Equipment Qualifications, HVAC Qualifications, process validations) as and when required.
•  I was conducting Training programs at LL sites.
•  Supported for closure of market complaints.
•  I was ensuring the release of batches as per provided schedule.
•  Involved in preparation of APQR, Audit Compliance reports and RCA.
•  I was responsible for implementing the GMP requirements at LL sites.
•  I was reviewing the Change Controls, Deviations, Audit Reports, Analytical Reports (RM/PM/FP) and CAPA of LL sites related to Cipla products.
•  Reviewed Facility Microbial monitoring and, Water (WFI/PW/PS) trend documents.
•  I was responsible for Investigation and closure of Facility, Equipment and Utilities related Discrepancies.

Nov 2006 – Apr 2009 · 2 yrs 5 mos

• Was responsible for fill finish activities,qualification,validation,SOP preparation and Batch release activities.