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
