15 Stability Protocol Jobs

As the Head of the DQA department in the Research & Development sector, your role involves leading the team to ensure the implementation of CGMP rules and regulations. Your responsibilities include: - Reviewing the Lab validation Protocol and Report of CRD. - Reviewing the Process Development report for DMF filing. - Reviewing the Specification and STP of Key Raw Material, In-Process, Intermediate stage, and Finished Product. - Reviewing the Method Development Report, Method Validation Protocol/Report, and Method Transfer Protocol of ADL. - Reviewing the stability protocol and Report. - Preparing SOP, Formats / Annexures, Log books, and ensuring RA and GLP Compliance. - Interacting and Commu...

You will be responsible for regulatory submission of new products, variations, response to queries, and life cycle management for the US and OAM regions. This will involve preparation of quality dossiers to ensure timely approvals. Key Responsibilities: - Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review documents such as Development report, scale up report, specification, stability protocol, analytical validation, etc., before initiation of Exhibit batches for adequacy. - Review & prepare responses to deficiencies to enable approval of products filed to regulatory agency. - Prepare and review variations, Annual notifications, and labelling...

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' ...

As a Quality Control Analyst at Piramal Critical Care (PCC), your primary responsibility is to complete assigned tasks and ensure training on activities as instructed by the supervisor or Head of Quality Control (HOD-QC) before execution. Your duties include reviewing data related to packing materials, raw materials, stability samples, in-process and finished products. Additionally, you will be responsible for reviewing Qualification, Validation, Calibration data, Procedures, and Audit Trails in a timely manner. If you identify any unsafe conditions or acts within the laboratory, you must report them to the supervisor or HOD-QC and ensure their resolution. Key Responsibilities: - Receive and...

Role & responsibilities : Reviewing, verifying, and processing of all technical documents for accuracy before compilation or submission of dossiers as per USFDA & PEPFAR requirements. Review and regulatory compliance of Initial ANDA Documents like Trade dress, Q1 and Q2, bio-wavier, IIG clearance, MDD evaluation, Size and Shape, Elemental iron, Residual solvent, Elemental impurity and Exactable and Leachable impurity, Specifications [API and Finished drug Product), Master Formula (with respect to Bio-waiver), Stability Protocol, Labeling Information, Product development Report, Method Validation Report, BMR and BPR etc. Participate and represent as regulatory team in meetings (Level 1 and 2 ...

As a Validation Specialist, your role involves preparing and reviewing protocols for various validation activities such as Process, Method, Cleaning, Computer System Validation, and Stability Protocol. You will also be responsible for Calibration and Qualification, Risk Assessment, and ensuring compliance with the timetable for all equipment validation from internal and external sources. Your duties will include periodic updating of the validation master plan and reviewing risk assessment reports for manufacturing site activities. Additionally, reviewing the Master Validation plan is also part of your responsibilities. Key Responsibilities: - Prepare and review validation protocols for Proce...

As an Assistant Manager/Manager in the Quality Assurance department, your role will involve the following key responsibilities: - Review and approve Standard Operation Procedures (SOP's) for all departments, ensuring timely review and revision as per the revision date. - Review and approve various validation protocols and reports including analytical method validation, process method validation, water system validation, and equipment/instrument qualification. - Approve raw material, packing material, semi-finished product, and final product specifications and test methods for analysis. Also, approve artwork and shade cards for printed packing material. - Review and approve stability protocol...

Authorize to prepare and review the following documents: a. Trial Batch /Development Batch Manufacturing Record. b. Trial Batch / Scale up batch protocol & report. c. All other documents (If any) from R&D and other locations 2. Responsible for monitoring of Trial / Development / Scale up / Exhibit batches to be executed in manufacturing area. 3. Responsible to coordinate with CFT members for preparation of production plan related to Trial/Development/Scale-Up/Exhibit batches. 4. Responsible to maintain the area with GMP compliance. 5. Responsible for handling of new products from R&D and other locations 6. Responsible for handling of technical issues/OOS/Deviation investigation related to on...

As the leader of the DQA department, your role is to ensure the implementation of CGMP rules and regulations in Research & Development. Your responsibilities include: - Reviewing the Lab validation Protocol and Report of CRD. - Reviewing the Process Development report for DMF filing. - Reviewing the Specification and STP of Key Raw Material, In-Process, Intermediate stage, and Finished Product. - Reviewing the Method Development Report, Method Validation Protocol/Report, Method Transfer Protocol of ADL. - Reviewing the stability protocol and Report. - Preparing SOP, Formats / Annexures, Log books, and ensuring RA and GLP Compliance. - Interacting and communicating with R&D, ARD, QA, and Regu...

As a Regulatory Submission Specialist, your role involves handling the regulatory submission of new products, variations, and responses to queries for the US and OAM regions. Your primary responsibility is to prepare quality dossiers to ensure timely approvals for life cycle management. Key Responsibilities: - Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review various documents such as Development reports, scale-up reports, specifications, stability protocols, and analytical validations before initiating Exhibit batches. - Prepare responses to deficiencies to facilitate the approval of products filed with regulatory agencies. - Manage the ...

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...

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...

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.

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

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' ...