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3.0 - 7.0 years
0 Lacs
karnataka
On-site
As a QMS Project Reviewer at Syngene International Limited in Bengaluru, you will play a vital role in drug substance development and manufacturing processes. Syngene is an innovation-led contract research, development, and manufacturing organization that offers integrated scientific services from early discovery to commercial supply. Safety is a top priority at Syngene, and you will be expected to adhere to safety guidelines, procedures, and SOPs to ensure a safe working environment for yourself, your team, and the lab/plant. **Key Responsibilities:** - Following GMP, GDP, and GLP procedures - Creating, revising, and reviewing procedures such as SOPs and protocols - Reviewing and approving ...
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a part of the Technology Transfer Team under the R&D vertical at Palli location, your primary responsibilities will include: - Preparing Master BMR and BPRs - Managing documents - Coordinating with various departments such as Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, and Engineering for the execution of Scale-up and Exhibit batches - Reviewing GMP related documents - Selecting equipment at the facility Your role will involve facilitating Change Controls for various reasons and initiating them due to revisions in BMR/BPRs and other PD related changes. You will also study critical parameters during scale-up batches to optimize the CPPs and CQAs, provi...
Posted 1 month ago
5.0 - 9.0 years
0 Lacs
ankleshwar, gujarat
On-site
As a Computer System Validation & QA-IT professional, your role involves various responsibilities related to process activities. Some of the key responsibilities include: - Reviewing Qualification and Re-Qualification protocols & reports. - Reviewing Preventive Maintenance & Calibration records. - Reviewing and approving critical consumable items. - Monitoring engineering & utility services such as facility layouts, building layout, material flow, HVACs, Nitrogen plant generation and distribution, purified water generation and distribution, and Equipment qualification. - Reviewing breakdown maintenance system. - Handling SAP activities for Engineering. - Managing new product introduction at ...
Posted 1 month ago
1.0 - 3.0 years
4 - 6 Lacs
Halol
Work from Office
Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance
Posted 4 months ago
4.0 - 6.0 years
8 - 10 Lacs
Halol
Work from Office
Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance
Posted 4 months ago
 
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