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4.0 - 8.0 years
0 Lacs
andhra pradesh
On-site
Role Overview: You will be responsible for documentation and execution of qualification activities. This includes preparation, review, and execution of various documents such as URS, DQ, FDS, UTM, IQ, OQ, PQ, RQ, and risk assessments. Your role will involve managing FAT and SAT for new projects, reviewing raw data and test reports, and preparing final summary reports. You will also be responsible for protocols and reports for validation processes, initiating CRNs, implementing CAPAs, and conducting incident investigations. Additionally, you will prepare and review VMP, provide training, update SOPs, and assist in inspections. Key Responsibilities: - Preparation, review, and execution of qual...
Posted 3 days ago
7.0 - 10.0 years
7 - 10 Lacs
ankleshwar
Work from Office
Role & responsibilities Preparation of Site Master File, Validation Master Plan and execution as per Plan, Preparation of Quality Manual & approved by QA Head, to prepare the standard operating procedures for conformance with good manufacturing practices & good laboratory practices. To take active part in conduction of an internal audit to ensure compliance to good manufacturing practices & other regulatory requirement, to review the market complaints.To review the product recall, To participate in validation of processing equipment, cleaning equipment, process & cleaning procedures are done on timely basis, to carry out the documentation in compliance with good manufacturing practices, prov...
Posted 1 month ago
4.0 - 10.0 years
0 Lacs
hyderabad, telangana
On-site
As a Commissioning and Qualification Engineer for Pharmaceutical equipment, your role will involve working with a range of equipment including RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators, RABs, GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. You will be responsible for developing various protocols such as CQMP, VMP, FRA, cGMP review sheet, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. In addition, you will execute Commissioning, qualification, and validation activities for Pharma Process Equ...
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
andhra pradesh
On-site
You will be responsible for documentation and execution of qualification activities. This includes preparation, review, and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ (Requirement Qualification) documents. Your responsibilities include the review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems. You will be responsible for new project-related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test). You will review and co...
Posted 2 months ago
3.0 - 7.0 years
0 Lacs
ghaziabad, uttar pradesh
On-site
As the Quality Control Officer, you will be responsible for ensuring the overall quality of products and compliance with GMP at the site. This includes conducting line clearance prior to dispensing, manufacturing, packing, and validation activities. You will also be involved in sampling during the manufacturing of validation, exhibit, and commercial batches, as well as in-process control, routine inspection, and online process verification and documentation. Your duties will involve the preparation, review, and approval of various documents such as SOPs, BMRs, BPRs, SMFs, VMPs, APQRs, MFR validation protocols/reports, and qualification protocols/reports. Additionally, you will be responsible...
Posted 3 months ago
4.0 - 10.0 years
0 Lacs
hyderabad, telangana
On-site
You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and clea...
Posted 3 months ago
3.0 - 4.0 years
4 - 8 Lacs
Hyderabad
Work from Office
Roles & Responsibilities: Collaborates with internal teams, including IS functions (Infrastructure, ITIL process owners), external service providers, Corporate Quality, and Medinfo business units. Leads and develops test plans, test cases, test scripts and test reports on multiple projects and ultimately validates that expectations of our users are met during the testing process Responsible for defect tracking, investigation, and resolution throughout testing and validation phases. Prepare, review, and approve test cases to validate system functionality and performance against business requirements. Review and execute Test Runs in alignment with pre-approved testing protocols and documentati...
Posted 5 months ago
8 - 10 years
12 - 14 Lacs
Gurugram
Work from Office
Purpose of the Manager Quality & Job Role: Aakash is looking for an experienced Manager Quality (Training & Development) who shall be responsible for monitoring, evaluating, and improving the quality of customer interactions in all branches Pan India (Telephonic & F2F). Role is very dynamic in nature and shall need an experienced and self-motivated professional who shall take full responsibility of individually assigned projects as well as team handling. This role involves analyzing performance data, coaching agents, and implementing strategies to enhance the overall customer experience. The Call Quality Manager would closely work with team leaders, trainers, and other business stakeholders ...
Posted 5 months ago
3.0 - 5.0 years
4 - 7 Lacs
ahmedabad
Work from Office
Job Location: Ahmedabad Experience Year : 3-5 Years Qualification: Bachelors Position: QA-CSV Job Type: WFO Company Name: GSC Technolabs. A Group of GSC Technologies Ltd. Key Job Responsibilities for a QA-CSV Role: Validation Planning: Develop and maintain Validation Master Plans (VMP). Define a validation strategy based on risk and regulatory impact Documentation: Create and review validation documentation, including: User Requirements Specifications (URS) Functional Specifications (FS) Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) Traceability Matrix Final Validation Reports Testing & Execution: Lead or perform Installation Qualification (IQ), Operational Qualification (OQ),...
Posted Date not available
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