Chennai Tamil Nadu Quality assurance regulatory affairs Jobs – 3 Open Jobs Today

Executive & Sr. Executive – Analytical Research & Development (Review)
Axxelent Pharma and Science Private Limited —Tharamani, Chennai, Tamil Nadu
- ₹2,60,000.00 - ₹12,31,916.17 a year
- Full-time
- Research
- Master's degree
- Analysis skills
- Flexible schedule
- Food provided
Quick apply
QA/RA
Hirely —Chennai, Tamil Nadu
- ₹2,55,242.59 - ₹12,31,037.05 a year
- Full-time
- Master's degree
- Analysis skills
- Bachelor's degree
Quick apply
7d
Freelance Medical & Regulatory Writer
Pepgra —Ambattur, Chennai, Tamil Nadu
- Doctoral degree
- English
- Master's degree

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3–8 years of experience in Regulatory Affairs and/or Quality Assurance within the Medical Device industry. Review Verification & Validation (V&V) documentation…
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7d
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13d

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Executive & Sr. Executive – Analytical Research & Development (Review)

Axxelent Pharma and Science Private Limited
Tharamani, Chennai, Tamil Nadu

Quick apply

Job details

Full-time
₹2,60,000.00 - ₹12,31,916.17 a year

Benefits

Provident Fund
Flexible schedule
Food provided

Qualifications

Research
Master's degree
Analysis skills
Quality assurance
Bachelor's degree
Technical writing
Research & development
Communication skills

Full job description

Location

Axxelent Pharma Science R&D Unit
IIT Madras Research Park
Taramani, Chennai, Tamil Nadu

Job Type: Full-time

About Us

Axxelent Pharma Science Private Limited is a research-driven pharmaceutical organization committed to delivering innovative, high-quality, and regulatory-compliant solutions for the global healthcare industry. We are looking for talented professionals to join our Analytical Research & Development (AR&D) team and contribute to scientific excellence.

Position Summary

We are seeking an experienced Executive / Sr. Executive – Analytical Research & Development (Review) to review analytical data, laboratory documentation, and scientific reports while ensuring compliance with GMP, regulatory guidelines, and data integrity standards. The ideal candidate should possess strong analytical knowledge, excellent documentation skills, and experience in pharmaceutical analytical review.

Key Responsibilities

Review analytical methods, laboratory notebooks, analytical data, and technical reports for accuracy and completeness.
Verify chromatographic data generated using HPLC, GC, UV, Dissolution, and other analytical instruments.
Review method validation, method verification, method transfer, stability studies, and analytical development reports.
Ensure compliance with GMP, GLP, ALCOA+, and Data Integrity principles.
Evaluate analytical results, identify discrepancies, and support investigations related to OOS, OOT, and laboratory deviations.
Review raw data and ensure proper documentation in accordance with regulatory requirements.
Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs, and Project Management teams.
Maintain review records and ensure traceability of all reviewed documents.
Support internal audits, customer audits, and regulatory inspections.
Recommend improvements in analytical documentation and laboratory review processes.

Required Qualifications

M.Pharm
B.Pharm
M.Sc (Chemistry / Analytical Chemistry / Pharmaceutical Chemistry)

Experience

4–7 years of experience in Pharmaceutical Analytical Research & Development.
Experience in Analytical Review, Quality Review, or Analytical Documentation Review is preferred.

Required Technical Skills

Analytical Method Development
Method Validation
Method Transfer
Stability Studies
Analytical Data Review
HPLC
GC
UV Spectroscopy
Dissolution
FTIR
Laboratory Documentation
GMP
GLP
ALCOA+
Data Integrity
ICH Guidelines
Regulatory Compliance
OOS & OOT Investigation
Technical Report Review

Preferred Skills

Strong analytical and problem-solving abilities.
Excellent documentation and technical writing skills.
Attention to detail with high accuracy in data review.
Ability to work independently and collaboratively.
Good communication and interpersonal skills.
Knowledge of USFDA, MHRA, EU GMP, WHO-GMP, and ICH regulatory expectations.

Why Join Axxelent Pharma Science?

Work on innovative pharmaceutical R&D projects.
Collaborative and research-focused work environment.
Opportunities for professional growth and career advancement.
Exposure to global regulatory standards and cutting-edge analytical technologies.

Salary

Best in Industry (Commensurate with qualifications and experience)

Application Process

Interested candidates can share their updated resume to:

[email protected]
[email protected]

Pay: ₹260,000.00 - ₹1,231,916.17 per year

Benefits:

Flexible schedule
Food provided
Provident Fund

Work Location: In person

Quick apply

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quality assurance regulatory affairs jobs in chennai tamil nadu

Executive & Sr. Executive – Analytical Research & Development (Review)

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Freelance Medical & Regulatory Writer

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