Key Skills

Job Description

Be the First to Apply Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com Job Title Executive - Quality Control Job Description Analyst who is able to performed analysis of AMV/AMT, finished product, stability samples and raw materials as per cGMP and USFDA requirement. Able to prepare protocol and report and other related documentation as per GDP. Should have hands-on experience on HPLC, GC, FTIR, Dissolution Test apparatus, KF, LC-MS/MS, AAS, Malvern PSD analyzer etc. Receipt/Inward/Storage of QC samples and Disposition of sample after analysis. Analyst who is able to performed analysis of AMV/AMT, finished product, stability samples and raw materials as per cGMP and USFDA requirement. Able to prepare protocol and report and other related documentation as per GDP. Should have hands-on experience on HPLC, GC, FTIR, Dissolution Test apparatus, KF, LC-MS/MS, AAS, Malvern PSD analyser etc. Should have sound knowledge of cGMP, GLP, GDP, ICH and ALCOA++ Receipt/Inward/Storage of QC samples and Disposition of sample after analysis. Concurrent documentation of analytical records and storage of raw data, online entries in Instrument/ Equipment’s usage logbooks. Instant reporting in case of any deviation, incident, OOT or OOS to Section Head/ Head QC. Any additional responsibility assigned by section head. Implementation of GLP / GMP requirements. To control and maintain QC Laboratory Records. (Like Laboratory, note Book and COA etc.). Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.

Core Responsibilities

Perform analysis of raw materials, finished products, and stability samples while maintaining strict compliance with cGMP and USFDA requirements. Responsible for preparing protocols, reports, and managing the receipt and disposition of QC samples.

Requirements

Requires hands-on experience with various analytical instruments such as HPLC and GC, and sound knowledge of GLP, GDP, and ICH guidelines. Must be capable of concurrent documentation and reporting deviations or OOS results.