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10.0 - 14.0 years
0 Lacs
vadodara, gujarat
On-site
As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corporate quality audit, and CMO site on manufacturing and technical matters. Additionally, you will be involved in authoring and reviewing quality agreements, ensuring the use of qualified service providers, participating in process validation batches, reviewing quality system documents, conducting visits based on market complaints/recalls/CAPA, reviewing batch records, stability data, and analytical reports, as well as preparing and reviewing SOPs. Your role will also include participation in the initial evaluation of CMOs, supporting regulatory audits at CMO sites, engaging in critical investigations, initiating QMS documents, preparing for regulatory agency inspections, participating in product release site audits, maintaining audit-related documents, preparing monthly reports, staying updated on regulations through training, and following Corporate Quality Policies/Global Quality Standards and Regulatory Guidelines. To be successful in this role, you should have an M.Sc./B.Pharm/M.Pharm or equivalent degree along with a total of 10 years of industrial experience and knowledge. You will also be expected to participate in and execute project work assigned by your reporting authority. If you are looking for a challenging opportunity to ensure quality compliance in contract manufacturing organizations and contribute to the overall quality standards of SUN Pharma, this role is ideal for you. Join us in our mission to maintain high-quality standards and regulatory compliance in the pharmaceutical industry.,
Posted 3 days ago
1.0 - 7.0 years
0 Lacs
ahmedabad, gujarat
On-site
You are invited to attend a walk-in interview at Zydus Biologics, Ahmedabad for the position of Warehouse Executive / FTE. As an Executive, you should possess an M.Sc./M. Com/ B.Sc. degree with 2-7 years of experience in GMP system. It is essential to have the ability to write QMS documents and demonstrate excellent knowledge of SAP, including proficiency in all T-Codes for tasks such as making GRN invoice, STO, and FG dispatches. You will be responsible for performing equipment validation and performance verification activities for the cell bank storage system, deep freezers, and temperature monitoring in the warehouse area. A solid understanding and experience in material management for raw material, consumable, API (DS), and drug product are required for this role. As a Fix Term Employee, candidates should have an HSC/ ITI qualification with 1-3 years of experience in handling and moving materials according to SOP. Responsibilities include material receiving, verification, documentation, dispensing/reconciliation of RMPM, and temperature and RH monitoring. The ability to perform cleaning activities is also essential for this position. If you are attending the interview, please remember to bring your latest resume, salary slips, CTC breakup, and all original academic documents. This opportunity is based in Ahmedabad, and the interview is scheduled for 12th July 2025 (Saturday) from 10:00 am to 3:00 pm at Zydus Biologics, Biotech Park, Opp. Ramdev Masala, Changodar Road, Ahmedabad-382213.,
Posted 1 week ago
2.0 - 6.0 years
0 Lacs
karwar, karnataka
On-site
The ideal candidate for this position should be prepared to work in rotational shifts. You should have practical experience working with API manufacturing equipment and be adept at troubleshooting any issues that may arise. A good understanding of clean room activities is essential for this role. It is important to strictly adhere to data integrity and safety protocols. Basic knowledge of Quality Management System (QMS) documents is also required. You should be transparent in your work approach, take ownership of assigned tasks, and communicate any relevant information to the supervisor in a timely manner.,
Posted 2 weeks ago
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