Adl Officer

Kopran Limited; Khopoli; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Kopran Limited seeks an Officer ADL in Savroli, Khalapur, Raigad, Maharashtra, to perform analytical testing, method development, and regulatory-support activities in a GMP/GLP environment.

The role requires MSc in Analytical Chemistry or M.Pharm (Pharmaceutical Analysis) and extensive hands-on experience with HPLC, GC, UV-Vis and FTIR instruments, ensuring data integrity and timely documentation.

Qualifications

• Hands-on experience with HPLC, GC, UV-Vis and FTIR techniques.
• Experience in method development and validation.
• Understanding of GMP, GLP and data integrity requirements.

Responsibilities

• Perform analytical method development, validation and verification for pharmaceutical products and raw materials.
• Conduct analytical testing using HPLC, GC, UV-Vis, FTIR and other relevant instruments.
• Support new product development, formulation development and technology transfer activities.
• Prepare, review, and maintain analytical protocols, reports, specifications and SOPs.
• Perform forced degradation, stability studies and impurity profiling as applicable.
• Ensure compliance with GMP, GLP, data integrity and regulatory requirements.

Skills

HPLC

GC

UV-Vis

FTIR

Analytical Method Development

Education

M.Sc. in Analytical Chemistry

M.Pharm (Pharmaceutical Analysis)

Job description

Role & responsibilities

Department: Analytical Development Laboratory (ADL)
Designation: Officer ADL
Industry: Pharmaceutical Industry
Qualification: M.Sc. in Analytical Chemistry / M.Pharm (Pharmaceutical Analysis)
Experience: 23 years of relevant experience preferred
Location: Savroli, Khalapur, Raigad, Maharashtra

1. Job Purpose

To perform analytical testing and method development, method validation, and analytical support for new product development, technology transfer, and regulatory requirements in compliance with applicable GMP, GLP, and data integrity guidelines.

2. Key Responsibilities

• Perform analytical method development, method validation, and method verification for pharmaceutical products and raw materials.
• Conduct analytical testing using HPLC, GC, UV-Visible Spectrophotometer, FTIR, and other relevant analytical instruments.
• Support new product development, formulation development, and technology transfer activities.
• Prepare, review, and maintain analytical protocols, reports, specifications, and standard operating procedures (SOPs).
• Perform forced degradation studies, stability studies, and impurity profiling, as applicable.
• Ensure compliance with GMP, GLP, data integrity, and applicable regulatory requirements.
• Maintain accurate laboratory records and ensure timely completion of analytical documentation.
• Coordinate with Formulation Development (F&D), Quality Control (QC), Quality Assurance (QA), and Regulatory Affairs teams.
• Ensure proper calibration, maintenance, and qualification status of analytical instruments.
• Investigate out-of-specification (OOS), out-of-trend (OOT), and atypical results, as applicable.
• Follow laboratory safety practices and maintain housekeeping standards.

Preferred candidate profile

• Hands-on experience with HPLC, GC, UV, and FTIR analytical techniques.
• Knowledge of analytical method development and validation.
• Understanding of pharmaceutical analysis, stability studies, and impurity profiling.
• Knowledge of ICH guidelines, GMP, GLP, and data integrity requirements.
• Good documentation, analytical problem-solving, and communication skills.
• Ability to work independently and coordinate effectively with cross-functional teams.

Preferred Experience

Experience in analytical development, new product development, technology transfer, and regulated or semi-regulated pharmaceutical markets will be an added advantage