# Nisha Thakur

Nisha Thakur is a remote worker on Himalayas, Digital Healthcare, Life Sciences & Pharma Consultant at Healthcare & Pharmacy Operations, based in India.

Source: https://himalayas.app/@nishathakur2

```text
Quality assurance and regulatory compliance professional in life sciences who managed audits and strengthened quality systems across pharma operations.
```

| Detail | Value |
| --- | --- |
| Availability | Looking for a job |
| Location | India |
| Authorized to work in | India |
| Salary expectations | 2500k+ INR |
| Job categories | Quality Assurance and Regulatory Compliance Specialist, Regulatory Affairs Manager, Quality Systems Manager |
| Skills | Quality Management Systems, CAPA, GMP Compliance, CGMP Compliance, Audit Management, Audit Readiness, Change Control, Deviation Management, Non Conformance Management, Market Complaint Trend Analysis, Annual Product Review, Quality Metrics, KPI Analysis, Statistical Process Improvement, SOP Management |
| LinkedIn | https://linkedin.com/in/nisha-katoch-38776a42 |

## About

```text
At Abbott Healthcare, I owned end-to-end Quality Assurance processes covering CAPA, deviations, change controls, documentation, and regulatory compliance. I also led market-complaint trend analysis to identify recurring quality issues.

I served as a Certified cGMP Trainer, creating training matrices, master training planners, and effectiveness evaluations. I managed artwork review and approval and supported SOP and artwork transition during the Piramal-to-Abbott organizational transition.

As a Digital Healthcare, Life Sciences & Pharma Consultant, I managed regulatory inspections and audits, serving as the direct point of contact with external agencies. I also implemented pharmacy store software to digitize operational records and improve compliance visibility.

Earlier, at Medreich, I managed artwork and quality documentation across seven manufacturing sites and supported CAPA review and tracking. At CIPLA India, I improved product yield from 95.8% to 98.3% for the top 20 products through quality-focused production planning.
```

## Experience

### Digital Healthcare, Life Sciences & Pharma Consultant

Healthcare & Pharmacy Operations. Jan 2016 - Jan 2026

```text
Managed regulatory inspections and audits involving Drug Inspectors and state drug regulatory authorities, serving as the direct point of contact between the business and external agencies. Built structured operational, supplier, inventory, and compliance processes to maintain storage compliance and healthcare-product availability.
```

Skills: Audit-Management, Compliance, Supplier-Management, Inventory-Management, Pharmacy-Software, Continuity-Planning

### Associate Manager, Digital Quality & Pharma Transformation

[Abbott Healthcare](https://himalayas.app/companies/abbott). Jan 2008 - Jan 2016

```text
Owned end-to-end Quality Assurance processes — change controls, deviations, CAPA, documentation, and regulatory compliance — driving process effectiveness across QA operations. Led market-complaint trend analysis to identify recurring quality issues and drive continuous improvement.
```

Skills: Quality-Management-Systems, CAPA, Change-Control, Deviations, Documentation, CGMP-GxP-Training, Artwork-Review, SOP-Management, Complaints-Analysis

### Corporate QA Executive, Life Sciences Quality & Systems

Medreich. Jan 2008 - Dec 2008

```text
Managed artwork and quality-documentation activities across seven manufacturing sites, standardizing quality processes and controlled SOPs nationally. Supported CAPA review and tracking across manufacturing sites, improving cross-site visibility of quality actions.
```

Skills: Artwork-Management, Quality-Documentation, CAPA, SOP-standardization, SAP, BOM-creation

### QA Officer, Pharma Quality & Digital Documentation

CIPLA Export Unit, Bangalore. Jan 2007 - Jan 2008

```text
Conducted routine QA audits across Stores, Quality Control, Engineering, and Production, resolving issues through established procedures. Maintained documentation supporting MHRA and USFDA regulatory audits.
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Skills: QA-auditing, Regulatory-Documentation, MHRA, FDA, SOP-Review, Investigation-Coordination

### Production Officer, Pharma Manufacturing Operations

CIPLA India. Jan 2005 - Jan 2007

```text
Improved product yield from 95.8% to 98.3% for the top 20 products through quality-focused production planning. Implemented Process Change Notes to support controlled operational changes across 16 packing lines.
```

Skills: Production-Planning, Change-Management, Master-Batch-Records, Documentation, Yield-improvement

## Education

### Punjab Technical University

MBA, Human Resource and Marketing

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MBA in Human Resource and Marketing from Punjab Technical University, completed in 2008.
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### North Maharashtra University

Bachelor of Pharmacy, Pharmacy

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Bachelor of Pharmacy (B.Pharm) from North Maharashtra University, completed in 2005.
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### Coursera

Certificate, Artificial Intelligence and Machine Learning

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Completed courses on Fundamentals of AI and ML, and Digital Life Science, Pharma and Healthcare.
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## Tech stack

- SAP

To contact Nisha, message them from this profile with a Himalayas employer account: [Hire on Himalayas](https://himalayas.app/hire).

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