QA Sterile Manager Sun Pharmaceutical Industries Ltd

10.0 - 14.0 years

0 Lacs

dewas, madhya pradesh

On-site

You will be joining Sun Pharmaceutical Industries Ltd as a QA Sterile Manager in the Quality Assurance department. Your role will involve managing the Quality Assurance functions of the Manufacturing Block P. As the Manager-I, you are required to hold an M.Sc. degree in Biotechnology, Microbiology, or Chemistry with over 10 years of experience in the field. Your responsibilities will include ensuring that manufacturing and packing processes are carried out per SOPs and cGMP regulations. You will be responsible for certifying batch production records, releasing/rejecting batches after thorough reviews, and tracking the QMS system. It will be your duty to investigate complaints, deviations, OOS, and stability failures, ensuring timely closure and contamination controls as per the contamination controls strategy. You will collaborate with various departments like planning, QC, Regulatory Affairs, Manufacturing, and Engineering to ensure batches are released on time. Your role will involve participating in self-audits, aseptic simulations, and identifying opportunities for continuous improvement in compliance, process clarity, and operational efficiency. Reviewing and approving various documents such as master batch production records, protocols, reports, and stability sample management will also be part of your responsibilities. Additionally, you will manage activities related to IPQA, line clearance, in-process checks, calibration records, artwork approval, and provide training to support staff. Your focus will be on enhancing knowledge of cGMPs, improving practices, complying with the Quality Policy, and enhancing systems and procedures to ensure the quality of products manufactured and delivered meets the required standards.,

Posted 3 days ago

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Assoc I, Quality Assurance Baxter Medical Devices

0.0 years

0 Lacs

ahmedabad, gujarat, india

On-site

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. QA overview for clean room behavior and aseptic activity. Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. Review of documents of respective areas and logbooks for adequacy and completeness. QA overview for receipt of material from warehouse to production. IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. To execute the Corrective and Preventive Action (CAPA) defined by Quality Management System (QMS) To give non-compliance reports to the respective departments in case of internal quality audits and report it to Section Head and Department Head. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

Posted 5 days ago

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