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5 Stability Protocol Jobs

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5.0 - 9.0 years

0 Lacs

maharashtra

On-site

As an Assistant Manager/Manager- Quality Assurance, your responsibilities will include: - Reviewing and approving Standard Operation Procedures (SOP's) for all departments, ensuring timely completion of reviews and revisions according to the specified revision date. - Evaluating and approving analytical method validation protocols and reports, process method validation protocols and reports, water system validation protocols and reports, as well as equipment/instrument qualification protocols and reports. - Reviewing and approving raw material, packing material, semi-finished product, and final product specifications and test methods for analysis. Approving artwork and shade cards for printe...

Posted 3 weeks ago

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5.0 - 9.0 years

0 Lacs

dehradun, uttarakhand

On-site

You will be responsible for preparing and reviewing protocols for various validation activities such as Process, Method, Cleaning, Computer System, and Stability Protocols. You will also be involved in Calibration and Qualification, as well as Risk Assessment processes. Your duties will include preparing and reviewing reports related to Qualification and Validation. It is essential to ensure that all equipment, whether from internal or external sources, undergoes Qualification and Validation within the specified timetable to maintain compliance. You will be required to periodically update the validation master plan and review risk assessment reports for activities conducted at the manufactur...

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6.0 - 8.0 years

4 - 5 Lacs

Bengaluru

Work from Office

Roles and Responsibilities Develop new products by formulating, developing, and launching solid oral products. Conduct bioanalytical testing to ensure product quality and stability. Collaborate with cross-functional teams for process development, PDR (Process Development Research), MFR (Manufacturing Formulation Research), FD Trial (First Time Right Trial). Ensure compliance with regulatory requirements through documentation of SOPs, BPRs, and batch records. Provide technical support to production team on product-related issues.

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2.0 - 7.0 years

3 - 8 Lacs

Mumbai, Mumbai Suburban, Mumbai (All Areas)

Work from Office

Looking candidates for PDR (Formulation & Development ) Dept. 2-7 years of relevant experience in solid oral dosage (Regulated Market) Roles and Responsibilities 1.Candidate should perform literature search 2.Pre formulation development Required Candidate profile 1.knowledge of documents – Master formula card, Bill of Material, stability protocol 2.Preparation of various documents like PDR, stability protocol, development report writing FDR/PDR

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3.0 - 8.0 years

5 - 15 Lacs

Gandhinagar

Work from Office

Analytical Development Laboratory Position: Executive Experience: 3-8 years Qualification: M.Sc. / M.Pharm. Job Responsibilities: HPLC/GC/IC method development, feasibility, verification, equivalency, validation of API for complex OSD products, oncology products, topical products having exposure to regulated, Semi Regulated & India markets Comparative evaluation of methods with alternative vendor methods versus existing primary vendor and regulatory impact analysis Dissolution development, comparative dissolution, multimedia dissolution and statistical evaluation and report preparation Good understanding and hands on experience of analytical instruments like HPLC, IC, GC etc. NI/GI & NDSRI' ...

Posted 3 months ago

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