ADL Sr. Officer

Company Description

Sushen Medicamentos Pvt. Ltd. is a trusted partner to global pharmaceutical companies, specializing in product management, plant design, and engineering services compliant with WHO-GMP, USFDA, and EU-GMP standards.

With a state-of-the-art laboratory, advanced technologies, and a highly skilled team of engineers and pharmacists with over 20 years of industry expertise, Sushen excels in oral solid dosage (OSD) development, stability studies, and technology transfer.

The company has successfully executed 40+ projects worldwide, serving regulated and emerging markets across the US, Europe, CIS, Middle East, Latin America, Africa, South East Asia, and India.

Job Summary:

The ADL Executive is responsible for supporting the development and validation of analytical methods, conducting routine analysis of pharmaceutical products, and ensuring compliance with regulatory standards. The role involves working closely with cross-functional teams, ensuring that all analytical procedures align with the company’s quality standards.

Key Responsibilities:

· Method Development and Validation:

o Assist in the development, optimization, and validation of analytical methods for raw materials, intermediates, and finished products using techniques such as HPLC, GC, and spectrophotometry.

o Conduct analytical testing for method validation in compliance with ICH guidelines.

· Routine Analysis:

o Perform routine quality control tests on pharmaceutical products to ensure they meet company and regulatory standards.

o Analyze raw materials, in-process samples, and finished products for various physical and chemical parameters.

· Documentation:

o Maintain accurate and detailed laboratory records, including test results, equipment logs, and validation documents.

o Prepare and review standard operating procedures (SOPs) and analytical method documents.

· Regulatory Compliance:

o Ensure that all activities are in compliance with GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) regulations.

o Support regulatory audits and inspections by preparing necessary documentation and reports.

· Equipment Calibration and Maintenance:

o Ensure proper calibration and maintenance of laboratory equipment.

o Troubleshoot any issues with analytical instruments and arrange for repairs when needed.

· Team Collaboration:

o Work closely with formulation, R&D, and production teams to support product development and troubleshooting.

o Collaborate with cross-functional teams on various projects.

Qualifications and Skills:

· Bachelor’s/Master’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field.

· 2+ years of experience in an analytical development laboratory (preferably in the pharmaceutical industry).

· Proficiency in analytical techniques like HPLC, GC, FTIR, UV-Vis spectroscopy, etc.

· Familiarity with regulatory guidelines (e.g., ICH, FDA, EMEA).

· Strong attention to detail and excellent organizational skills.

· Effective communication and teamwork skills.

· Ability to work under tight timelines and manage multiple projects.

Preferred Skills:

· Knowledge of stability studies and forced degradation studies.

· Experience with analytical method transfers between laboratories.

· Hands-on experience with advanced analytical instruments like LC-MS or NMR.

Interested candidates can apply via LinkedIn or share their CV at: