Srishti Kumari

Operations Associate

Indore, Madhya Pradesh, India10 yrs 3 mos experience

Most Likely To SwitchHighly Stable

Key Highlights

8 years of experience in quality and compliance.
Expert in leading quality improvement initiatives.
Strong background in regulatory compliance and audits.

Stackforce AI infers this person is a Quality and Compliance Specialist in the Pharmaceutical industry.

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Skills

Core Skills

Quality ManagementRegulatory ComplianceResearch

Other Skills

5S5S implementationAcclimatizationAdvanced user on Microsoft Windows and Microsoft Office applicationAudit ManagementAuditingBMRAMBlue mountainCAPACaliber eLogChange ControlCommunicationCompliance ManagementCompliancewireComputer

About

To Achieve, To Exceed, To Excel...!!!

Experience

10 yrs 3 mos

Total Experience

2 yrs 6 mos

Average Tenure

3 yrs 10 mos

Current Experience

Ipca laboratories limited

Compliance Operations (Site Head Office)

Aug 2022 – Present · 3 yrs 10 mos · Indore, Madhya Pradesh, India · On-site

Dynamic pharmaceutical professional with 8 years of experience supporting senior leadership and driving quality, compliance, and operational excellence. Proven ability to manage cross-functional coordination, regulatory compliance, and continuous improvement projects across QA, manufacturing, packing, and QC functions. Served as a key liaison for the Site Head, overseeing strategic meetings, action tracking, and communication management.
📌 Key Responsibilities:
In the current role, responsible for planning, prioritizing, and tracking meetings for the Site Head based on business priorities, and representing the Site Head in meetings when required. Captures minutes of meetings (MoMs), develops actionable plans, and monitors progress across departments to ensure timely execution.
Coordinates internal and external communications on behalf of senior management and compiles monthly and quarterly reports for QA and Operations. Ensures timely closure of internal and external audit observations while monitoring QMS activities across departments for GMP and regulatory compliance.
Collaborates with cross-functional teams (CFTs) to lead and execute quality and process improvement initiatives. Actively facilitates Lean and Six Sigma strategies, including OEE improvements, 5S implementation, Theory of Constraints (TOC), and waste reduction.
Conducts performance analysis through MIS dashboards, tracking KPIs such as OEE, machine downtime, manpower utilization, and changeover times. Leads change management efforts and project execution within the team.
Coordinates with external laboratories to ensure the timely release of products in line with cGMP and regulatory requirements. Experienced in using software systems such as TrackWise, EDMS, New LIMS, AMS, SCM, and HRMS.

Quality SystemRegulatory ComplianceProject ManagementChange ControlLeanSix Sigma+3

Endo pharmaceuticals

Compliance Executive

Aug 2021 – Jul 2022 · 11 mos · Chennai, Tamil Nadu, India · On-site

Was experienced in handling a variety of software including Salesforce, Visio, Compliancewire, HRMS, VeevaVault, Master Control, and BMS. Had a strong background in Quality Management Systems (QMS), covering change control, deviations, CAPA, risk assessments, and master document reviews and approvals. Prepared R&D batch records, SOPs, protocols, and risk assessments.
Demonstrated expertise in qualification processes such as URS, SOPs, protocols, and reports. Managed business administration activities including GxP training coordination, audits, safety programs, self-inspections, and soft skills enhancement.
Led continuous improvement initiatives including OEE, Six Sigma, 5S, and document simplification. Oversaw audit processes to ensure adherence to cGMP and data integrity (DI) standards.
Regularly contributed to weekly and monthly meetings through presentation preparation and supported quality and yield improvement efforts. Possessed hands-on knowledge of quality tools such as Fault Tree Analysis (FTA), HACCP, 5 Why analysis, FMEA, Ishikawa diagrams, brainstorming techniques, and Genchi Genbutsu.

Quality Management Systems (QMS)SalesforceVeevaVaultCAPARisk AssessmentChange Control+1

Strides

3 roles

Executive

Apr 2018 – Aug 2021 · 3 yrs 4 mos · Puducherry, Puducherry, India · On-site

Was proficient in using quality and compliance software including Trackwise, Visio, Compliancewire, Caliber eLog, BMRAM, and OAMS (Omniflow). Had strong expertise in Quality Management Systems (QMS), with hands-on experience managing change controls (PCCP & TCCP), deviations, CAPA, risk assessments, root cause investigations, effectiveness checks, and FMEA/QRM activities.
Served as a Functional Area Administrator (FAA), where responsibilities included coordinating training for revised documents and addressing audit findings. Contributed to continuous improvement projects such as OEE, Six Sigma, 5S, document and process simplification, and utilized Caliber eLogbook and LMS platforms.
Conducted cross-functional self-inspections to ensure compliance with cGMP and data integrity standards, and managed audit closures in line with regulatory and legal requirements. Gained experience in quantification processes, including CCP assessments for equipment, cleaning validations, and monitoring utility usage metrics.
Was skilled in preparing and maintaining documentation including SOPs, work instructions, batch records (BMR/BPR), qualification reports, and employee documentation such as job role matrices, mappings, and job descriptions.

Quality Management Systems (QMS)TrackwiseCompliancewireCaliber eLogFMEARisk Assessment+1

Executive Trainee

Nov 2017 – Apr 2018 · 5 mos · Puducherry, Puducherry, India · On-site

Management Trainee

Dec 2016 – Nov 2017 · 11 mos · Puducherry, Puducherry, India · On-site

Elsevier

Scientific Researcher

Dec 2015 – Oct 2016 · 10 mos · Bengaluru, Karnataka, India · On-site

Works for Elsevier B.V. is an academic publishing company that publishes medical and scientific literature. It is a part of the RELX Group. Based in Amsterdam, the company has operations in the UK, US, Mexico, Brazil, Spain, Germany, and elsewhere.
Maintaining PubMed website and SciVal Expert's profile in terms of expertise profiling and research networking tool to makes it easy for researchers, administrators, managers and senior leadership to find experts and enable collaboration within their institution and across organizations. [Powered by the Elsevier™]
Maintaining Experts profiling:
o Data mining
o Data analysis
o Data management
Profile Refinement:
o Analysing each articles published by Elsevier.
o Maintaining the database at quarterly intervals to an online database (SciVal Experts).
o Quality Assurance