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3.0 - 7.0 years
0 Lacs
maharashtra
On-site
As a remote analytical support personnel at PPL sites, your role involves reviewing analytical data and preparing various documents such as specifications, test methods, and protocols. You will be responsible for uploading documents for review in ENSURE and initiating QMS elements in TrackWise/eDMS. Additionally, you will prepare and review stability protocols and reports, and conduct stability data trending and analysis. Key Responsibilities: - Review analytical data generated in the analytical lab (QC/AS) including Cleaning verification data, IPC, raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data in accordance with cGMP...
Posted 1 month ago
0.0 years
0 Lacs
gurugram, haryana, india
On-site
What you will do: Coordinates microbiological and/or chemical testing, release of product and testing for validation protocols. Performs organism identification. Performs technical review of batch filling records to ensure quality of aseptic processes. Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives. Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process an...
Posted 3 months ago
3.0 - 7.0 years
0 Lacs
maharashtra
On-site
As a remote analytical support specialist at PPL sites, your main responsibility will be reviewing analytical data and preparing essential documents such as specifications, test methods, and protocols. You will be uploading documents for review in ENSURE and initiating QMS elements in TrackWise/eDMS. Additionally, you will also prepare and review stability protocols and reports, as well as perform stability data trending and analysis. Your day-to-day tasks will involve reviewing analytical data generated in the analytical lab, including cleaning verification data, IPC, raw materials, intermediates, finished products, stability, and method validation data in compliance with cGMP, GDP. You wil...
Posted 3 months ago
10.0 - 15.0 years
0 Lacs
karnataka
On-site
As an Associate Manager: Compliance QA Auditor at Syngene in Bangalore, you will play a crucial role in coordinating process excellence projects in Translational & Clinical Research, ensuring quality and compliance with GCP systems and practices. Your responsibilities will include leading the design and implementation of improvement initiatives for complex processes, conducting data trending and analysis, and performing internal audits for GCP Quality systems. You will be expected to identify process excellence projects for implementation, manage Internal Audits, and ensure compliance with GCP QA Audit Management and Corrective and Preventive Action (CAPA) Management Systems. Collaborating w...
Posted 4 months ago
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