5.0 - 9.0 years

0 Lacs

maharashtra

On-site

As a Micro Lead API at our Ahmednagar location in the grade of G9B- Sr. Manager 2, your primary responsibility will be to plan, review, and monitor all activities within the Microbiology department. You will lead the department, ensuring smooth coordination with other departments to prioritize tasks and provide timely support and testing to prevent delays in analysis. Your role will involve reviewing all departmental documents and results in the LIMS system specifically in the microbiology section. You will oversee the lysate sensitivity test, Bacterial endotoxin test of WFI and API products, as well as validate the bacterial endotoxin test and microbial quality of products. Additionally, you will be responsible for the procurement, receipt, storage, maintenance, and reconciliation of biological indicators, media, reagents, standard cultures, and bioball. Calibration and operation of the TOC analyzer, environmental monitoring activities, qualification, and calibration of all instruments in the microbiology laboratory will also fall under your purview. Participating in investigations, reviewing deviations/OOS/OOT/OOC/Lab Event, and SOP revisions in the micro section online are crucial aspects of your role. You will need to maintain logbooks, prepare and review GMP documents, ensure fumigation activities, and review trends for water and environmental monitoring. Adherence to online good documentation practices, validation of autoclave, Dry heat sterilizer (DHS), Incubators, Laminar Air flow, HVAC, preparation of reagents, inventory, and stock record maintenance, GLP compliance, and safety protocols are essential responsibilities. Furthermore, you will be expected to support review and compliance activities in the quality function, coordinate with corporate functions regarding microbiology activities, and follow any other responsibilities assigned by the Quality head. Graduates in Microbiology or equivalent with experience in Micro testing/leading are encouraged to apply.,

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QA documentation Ashkom

2.0 - 3.0 years

0 - 1 Lacs

Sanand

Work from Office

Role & responsibilities The individual should be documenting Annual Product Quality Review (APQR): Collection of process and quality data for all products. The individual is capable for management of Retain Samples: Storage, maintain, visual inspection & destruction of Retain samples of all FG samples. Management of central document room/Documents: Issuance, Retrieval, Destruction & Control of all the GMP documents (eg: facility documents, Batch records, Protocols, Reports, etc.) Key competencies Skill Required/ Tools/ Software: The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software.

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