Job Description

Position:

Quality Assurance (QA) Executive

Experience:

3-4 Years

Department:

Quality Assurance

Location:

-- Miyapur, Hyderabad

Industry:

Clinical Research Organization

Key Responsibilities

1. Audit & Compliance

Conduct internal audits, vendor audits, investigator site audits, and process audits as per the annual audit plan. Ensure compliance with

ICH-GCP

,

USFDA

,

EMA

,

DCGI

, and other applicable regulatory standards. Prepare detailed audit reports, CAPA reviews, and follow-ups.

2. Quality Management System (QMS)

Maintain and monitor QMS processes including

SOP management

,

deviations

,

change controls

,

CAPA

, and

risk assessments

. Assist in drafting, reviewing, and implementing SOPs and ensuring periodic revisions.

3. Document & Training Management

Oversee controlled documents, ensure proper archival procedures, and maintain document integrity. Coordinate and monitor training programs for clinical and operational teams.

4. Vendor & Site Oversight

Support qualification, evaluation, and periodic review of vendors (e.g., laboratories, clinical sites, service providers). Participate in vendor audits and maintain compliance documentation.

5. Regulatory Support

Support regulatory inspections and assist teams during

FDA

,

EMA

,

DCGI

, or sponsor audits. Ensure timely preparation of responses for audit findings and regulatory queries.

6. Continuous Improvement

Identify gaps in processes and suggest improvements. Participate in root cause analysis and ensure effective implementation of CAPA. Promote quality culture across the organization.

Key Skills & Competencies

Strong knowledge of

ICH-GCP guidelines

, ethical principles, and clinical trial processes. Hands-on experience with

QMS

, audits, deviations, CAPA, and SOP management. Excellent analytical, documentation, and communication skills. Ability to work independently and collaborate with cross-functional teams. Detail-oriented with strong organizational skills.

Educational Qualification

Bachelor's or Master's degree in

Life Sciences

,

Pharmacy

,

Biotechnology

, or related field. Additional certifications in

GCP

,

Quality Management

, or

Clinical Research

are an added advantage.

Preferred Experience

3-4 years of experience in a

CRO

,

pharmaceutical

, or

clinical research

QA role. Experience handling audits and interacting with regulatory authorities/sponsors. Exposure to eQMS systems is preferred.
Job Type: Full-time

Benefits:

Provident Fund
Work Location: In person