Noida Uttar Pradesh Pharmaceutical quality assurance Jobs – 5 Open Jobs Today

Director- Quality Assurance (QA)
Epoch Consulting —Noida, Uttar Pradesh
- ₹20,00,000 a year
- Full-time
- Nursing
- Analysis skills
- Project management
Quick apply
Customer Care Executive
Bakson Drugs & Pharmaceuticals Pvt Ltd —Noida, Uttar Pradesh
- ₹25,000 - ₹35,000 a month
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Customer service
- Health insurance
- Work from home
Quick apply
13d
ORACLE-Oracle SCM-CX-Campus-Noida-staff
EY —Noida, Uttar Pradesh
- Microsoft Excel
- Oracle
- Master's degree
Team Lead – IT QA & CSV
RxLogix —Noida, Uttar Pradesh
- Full-time
- Master's degree
- SQL
- Bachelor's degree
Principal Engineer – IT QA & CSV
RxLogix Corporation —Noida, Uttar Pradesh
- Full-time
- Master's degree
- SQL
- Bachelor's degree
Quick apply

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Director- Quality Assurance (QA)

Epoch Consulting -
Noida, Uttar Pradesh

Quick apply

Job details

Full-time
₹20,00,000 a year

Qualifications

Nursing
Clinical research
Biotechnology
Quality management
Analysis skills
Project management
Quality assurance
Bachelor's degree
Quality systems
Communication skills
FDA regulations

Full job description

Epoch Consulting Pvt. Ltd. is hiring for the below position for its client, a leading Contract Research Organization which is providing Clinical Research Services.

About our Client:

Our Client is a Contract Research Organization that was established in 2015 with a formidable team and experiences in Clinical Trials Phase I to Phase IV and Pharmacovigilance services.

Our Client continuously aims to design and provide quality and cost-efficient processes to make India a global leader in ethical clinical research. It provides comprehensive solutions in Clinical Project Management, Medical Writing, Regulatory Affairs, Data Management, and other core clinical trials solutions along with clinical safety and pharmacovigilance.

Job Description

Job Title: Director- Quality Assurance (QA)

Industry: Clinical Research / CRO

Department: Quality Assurance

Location: Noida

Employment Type: Full-Time

Position Overview

The Director – Quality Assurance (QA) will lead and oversee the organization’s Quality Management System (QMS) for all clinical research operations within the CRO. The role is responsible for ensuring compliance with applicable global and local regulatory requirements, including ICH-GCP, CDSCO, US FDA, EMA, MHRA, and other international standards relevant to clinical trials, pharmacovigilance, bioavailability/ bioequivalence studies, and related clinical research activities.

Key Responsibilities:

Technical Expertise:

Review and Approval of Protocols, Reports and associated Deviations as applicable.
Maintain SMF (Site Master File), Validation Master Plans & Inventory of systems.
Conducts training as required.
Generation of SOPs/ other documentation as applicable.
Maintain change control system.
Handling of quality elements (Change control, deviation CAPA, QRM, SOP, Quality metrics).

Quality Management & Regulatory Compliance

Lead the development, implementation, and maintenance of the organization’s Quality Management System (QMS).
Ensure compliance with applicable regulations and guidelines, including:
- ICH-GCP
- FDA regulations
- EMA requirements
- Applicable GxP standards
- Internal SOPs and sponsor requirements.
Develop, review, approve, and maintain quality policies, SOPs, and quality standards.
Monitor changes in global regulations and assess organizational impact.

Audit & Inspection Management

Plan, manage, and oversee internal and external audits, including:
- Investigator site audits
- Vendor audits
- Process and system audits
- Trial Master File (TMF) reviews.
Lead organizational readiness for sponsor audits and regulatory inspections.
Ensure timely resolution of audit findings and regulatory observations.

CAPA & Risk Management

Oversee Corrective and Preventive Action (CAPA) processes, including root cause analysis and effectiveness checks.
Implement risk-based quality management strategies to support proactive compliance oversight.

Vendor & Operational Oversight

Support vendor qualification, evaluation, and oversight activities.

Leadership & Training

Lead and mentor QA staff and cross-functional quality teams.
Support GxP and compliance training initiatives across the organization.
Provide strategic QA guidance to senior leadership and project teams.

Qualifications

Education

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or related field required.
Advanced degree preferred.

Experience

Minimum 10 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or CRO industry.
At least 5 years in a leadership or management role.
Strong experience in GCP/GxP compliance and quality systems management.
Demonstrated experience managing regulatory inspections and client audits.

Knowledge & Skills

In-depth knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements.
Strong understanding of quality systems, CAPA management, and risk-based quality approaches.
Excellent leadership, communication, and stakeholder management skills.
Strong analytical, problem-solving, and organizational abilities.
Experience with electronic QMS systems and audit management tools preferred.

Core Competencies

Strategic Leadership
Regulatory & Compliance Expertise
Audit & Inspection Management
Risk Assessment & Mitigation
Process Improvement
Team Development
Cross-Functional Collaboration
Attention to Detail
Ethical & Professional Integrity

Company Details

Website: Website and Company name will be shared

Working Days: 5.5 Days Working [1st n 3rd Saturday is working, 2nd and 4th saturday will be off]

Job Type: Full-Time, Permanent

Quick apply

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pharmaceutical quality assurance jobs in noida uttar pradesh

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About our Client:

Job Description

Job Title: Director- Quality Assurance (QA)

Position Overview

Key Responsibilities:

Technical Expertise:

Quality Management & Regulatory Compliance

Audit & Inspection Management

CAPA & Risk Management

Vendor & Operational Oversight

Leadership & Training

Qualifications

Education

Experience

Knowledge & Skills

Core Competencies

Company Details

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