Description: This role is responsible for conducting in-process and final product quality testing and analyses in strict compliance with established standards and regulatory requirements within a global pharmaceutical ma…
Skills: Microbiology Instrumentation, Good Laboratory Practices, Documentation Accuracy, Data Integrity, Regulatory Compliance
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Skills: Process Engineering, People Management, Strategic Planning, Talent Acquisition, Learning And Development
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Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosag…
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Essential Functions – Officer, Quality Control • Execute routine preventive maintenance, calibration, and verification activities of QC instruments as per approved SOPs. • Perform analysis and support timely release of r…
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Essential Functions Perform microbiological testing of APIs, purified water, and environmental samples as per approved specifications and methods. Conduct sampling and testing of water systems (PW) and environmental moni…
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Skills: Analytical R&D, API Development, Laboratory Analysis, Pharmaceutical Research, Quality Control
Piscataway Township, New Jersey, United States · On-site
$26/hr–$35/hr
Mid level$3.2B raised
Description: This role is responsible for the set-up, adjustment, maintenance, and troubleshooting of line equipment in compliance with Good Manufacturing Practices (GMP) and regulatory standards. The Set-Up Mechanic wil…
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Full-time
bachelor degree, postgraduate degree
Posted 8d ago
Apply by Aug 7
~40 hrs/week
Responsibilities
This role involves conducting in-process and final product quality testing in a pharmaceutical manufacturing environment to ensure compliance with regulatory standards. The officer interprets analytical results, identifies process deviations, and supports continuous improvement initiatives through proactive testing and documentation.
Requirements
Candidates must hold a B.Sc. or M.Sc. in Microbiology and possess at least two years of relevant experience. Proficiency in microbiology instrumentation, GLP, and regulatory documentation is required for this position.
Full job description
Description:
This role is responsible for conducting in-process and final product quality testing and analyses in strict compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates analytical results in terms of accuracy and precision against predefined specifications to ensure product integrity. Various measuring devices, testing equipment, and predetermined methods are employed to accept or reject products based on prescribed specifications. The role contributes to identifying ongoing quality issues and preventing potential production problems through proactive testing and timely escalation. Manufacturing process deviations and defects in finished goods are identified, documented, and reported in accordance with Good Manufacturing Practices. Random samples of finished goods are tested to verify conformance with internal and regulatory quality standards. The position supports continuous improvement initiatives by suggesting enhancements to testing methods and quality processes. It operates within a structured quality management framework aligned with 21 CFR Part 210 and 211, ICH guidelines, and applicable Indian and international pharmaceutical regulations.
Skills and Proficiency:
Microbiology Instrumentation Handling – Expert
Good Laboratory Practices (GLP) & Documentation Accuracy – Practitioner
Data Integrity & Documentation – Practitioner
Regulatory Compliance – Practitioner
SOP Preparation & Revision – Practitioner
BET & Sterility testing expertise and evaluation skills – Expert
Interpretation of Resulting Data Trend – Practitioner
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Offices: 400 Crossing Boulevard, Bridgewater, New Jersey 08807, US
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Offices: 400 Crossing Boulevard, Bridgewater, New Jersey 08807, US