Assistant Manager QA

Job Description

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Assistant Manager QA Job Requisitions No : 13774 Job Description Purpose of Job Responsible for overall Monitoring and Compliance of documentation and IPQA activities of DS Manufacturing related to Manufacturing facility Responsible for APQR preparation related to CI & DS, Skill Required Good Review skills with exposure of Biopharma QA Roles and Responsibilites Review of new & revised documents i-e SOP, BPCR, MPCR, PTD, TTD, Validation Protocol, Report and QRM related to BBM facility, Review and to ensure timely completion of BPCR of products (CI and DS) manufacturing in BBM for release Authorized for batch release of Critical Intermediates, Drug substance and associated in-house media, buffer and column BPCRs, Review, monitoring and follow up for timely completion of CAPA, Deviations, Change Controls, OOT, OOS, IQA/external audit observations/, etc Handling and Assessment of Breakdowns, Alarms, SAP Incidents, ERN related to BBM facility Review of electronic data/audit trail data related to BBM facility, Monitoring and participation in process validation activities of BBM Review/Approval and compilation of Process validation documentation, Monitoring and participation in cleaning validation activities of BBM Review/Approval and compilation of cleaning validation documentation, Issuance of Working Cell Bank & Master Cell Bank, EPCBs and related documentation Ensuring physical reconciliation of cell banks, Qualification Required Sc Relevant Skills / Industry Experience Good Review skills QA Biopharma experience of more than 7-8 years, Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Biotech, Ahmedabad, GJ, IN, 382213 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025