Bioanalytical QA Executive Hiring – Quality Assurance & Documentation (CRO)

Jobs On The Way; Thane; Vor Ort; INR 450.000 - 650.000; Vollzeit

Zusammenfassung

Jobs On The Way is seeking a Bioanalytical QA Executive to support compliance, audits and quality documentation for bioanalytical laboratory operations within a regulated CRO environment.

The role requires 2–3 years of QA experience in bioanalytical laboratories, with CRO background preferred. Qualifications include M.Sc / B.Pharm / M.Pharm, and a strong grasp of GLP/GCP and audit processes.

Qualifikationen

• 2–3 years of experience in Bioanalytical Quality Assurance.
• Prior experience in a CRO environment is highly desirable.
• Hands-on QA experience in bioanalytical laboratories with emphasis on regulatory compliance.

Aufgaben

• Conduct internal, in-process, retrospective, and vendor audits as per approved SOPs.
• Ensure compliance with GLP, GCP, and applicable regulatory guidelines.
• Review bioanalytical study data for accuracy, integrity and compliance.
• Review bioanalytical method validation and amendment documents.
• Review qualification and calibration records of laboratory instruments and equipment.
• Prepare, update and review departmental SOPs.
• Review QMS documentation including change controls, deviations, incidents and CAPA.
• Support audit readiness and continuous quality improvement initiatives.

Kenntnisse

Bioanalytical QA

GLP/GCP

Documentation

Audit

Regulatory compliance

Ausbildung

M.Sc

B.Pharm

M.Pharm

Tools

SOPs

QMS

Jobbeschreibung

Are you an experienced Bioanalytical Quality Assurance professional looking to grow your career in a regulated CRO environment? We are hiring a QA Executive – Bioanalytical to support compliance, audits, and quality documentation for bioanalytical laboratory operations.

This opportunity is ideal for professionals with hands‑on QA experience in bioanalytical laboratories who are passionate about regulatory compliance and quality systems.

Department

Quality Assurance & Documentation

• Role: Executive – Bioanalytical QA
• Experience: 2–3 Years (CRO experience preferred)
• Qualification: M.Sc / B.Pharm / M.Pharm

As a Bioanalytical QA Executive, you will ensure adherence to quality systems and regulatory guidelines across laboratory activities.

Key responsibilities include:

• Conducting internal, in‑process, retrospective, and vendor audits as per approved SOPs
• Ensuring compliance with GLP, GCP, and applicable regulatory guidelines
• Reviewing bioanalytical study data for accuracy, integrity, and compliance
• Reviewing bioanalytical method validation and amendment documents
• Reviewing qualification and calibration records of laboratory instruments and equipment
• Preparing, updating, and reviewing departmental SOPs
• Reviewing QMS documentation, including change controls, deviations, incidents, and CAPA
• Supporting audit readiness and continuous quality improvement initiatives

Skills & Candidate Profile

• 2–3 years of experience in Bioanalytical Quality Assurance
• Prior experience in a CRO environment is highly desirable

Key Skills:

• Strong understanding of GLP, GCP, and regulatory requirements
• Knowledge of bioanalytical workflows and QA systems
• Excellent documentation review and reporting skills
• Strong communication and coordination abilities
• Detail‑oriented, compliance‑focused mindset

Why Apply?

• Work in a regulated bioanalytical CRO environment
• Gain exposure to regulatory‑compliant bioanalytical studies
• Strengthen expertise in audits, QMS, and quality systems
• Clear growth opportunities within Quality Assurance & Documentation