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Amneal Pharmaceuticals
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Executive, Method Development - Extractable & Leachable | OSD

Executive, Method Development - Extractable & Leachable | OSD

Amneal Pharmaceuticals

3 - 5 years

0 Lacs

ahmedabad gujarat india

Posted:2 days ago| Platform:

Apply

Skills Required

development packaging extraction analysis testing compliance report data reports documentation calibration maintenance polymer risk assessment interpretation communication diversity management support learning

Work Mode

On-site

Job Type

Full Time

Job Description

Key Responsibilities

Conduct extractables and leachable studies on packaging components, medical devices, and drug products.

Perform sample preparation, extraction, and analysis using techniques such as HPLC , GC-MS, LC-MS, ICP MS , ICP OES and other relevant instrumentation.

Develop and validate analytical methods for E&L testing in compliance with regulatory guidelines (e.g., USP , ).

Interpret and report analytical data, including identification and quantification of unknown compounds.

Prepare technical reports, protocols, and documentation for regulatory submissions.

Maintain laboratory instruments and ensure calibration and preventive maintenance schedules are followed.

Collaborate with cross-functional teams including formulation, regulatory affairs, and quality assurance.

Ensure compliance with GLP/GMP standards and laboratory safety protocols.

Additional Skills

Experience with polymer chemistry and material characterization.
Familiarity with toxicological risk assessment and safety thresholds, if possible

Qualifications

Qualifications and Experience

M.Sc. / M. Pharm / Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field.
3-5 years of experience in extractables and leachable testing.
Proficiency in HPLC, GC-MS, LC-MS, ICP MS , ICP OES and other analytical techniques.
Strong understanding of regulatory requirements for E&L studies.
Experience in method development, validation, and troubleshooting.
Excellent documentation, data interpretation, and communication skills.

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The

Human Resources team

partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.

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Executive, Method Development - Extractable & Leachable | OSD