38 Validation Protocol Jobs

Dear All, We are looking for an experienced professional to lead Analytical Method Validation activities for Finished Dosage Formulations (OSD) . The ideal candidate should have extensive experience in analytical development, method validation, and regulatory compliance for both domestic and international markets. Experience: 5-7 Years Location: Hyderabad(Dulapally) Key Responsibilities: Plan, design, and execute Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) activities for formulations as per regulatory guidelines (ICH, USP, EP, WHO, etc.). Review and approve Validation Protocols, Reports, Method Development Reports, and Specifications. Ensure method robustness, acc...

Job Responsibilities: 1. QMS, Quality system development 2. Regulatory compliance 3. Document review and approval 4 . Audits and inspections 5. Validation , T & D. 6. Stability Studies 7. Documentation, Vendor Audit Preparation & Compliances Provident fund Health insurance Annual bonus

As the Block Head / Production Manager at Ankleshwar Unit 2, your key role involves overseeing the production planning and execution process. Your responsibilities include: - Managing the plant manpower according to production planning - Handling raw material management in alignment with production planning - Coordinating with cross-functional departments for production requirements - Ensuring documents are prepared and reviewed, and approved by QA for production of intermediates or API - Ensuring department procedures comply with system SOPs and departmental SOPs - Reviewing and ensuring completion of production batch records - Reporting and evaluating production deviations and incidents, i...

Job Title: Utility Executive Exp:6 to 8 yrs in API industry Qualification:B.Tech CTC: 7 Lakhs JOB RESPONSIBILITIES: Preparation of draft SOPs and preparation of Protocols time to time as per the plant equipment requirements. Preparation of Preventive maintenance schedules and execution as per the procedures. Preparation of Validation schedules and execution as per the procedures. Preparation of Master equipment lists in the plant as per the procedures. Execution of ISO 9001, cGMP & ICH Q7 guidelines. Updating history cards & preventive maintenance records. Ensuring the smooth operation & maintenance of water systems. Ensuring the smooth operation & maintenance of Boilers. Ensuring the smooth...

As a skilled individual in the Microbiology department, you will be responsible for various tasks related to media preparation, incubation conditions, storage, and validation protocols. Your key responsibilities will include: - Performing media preparation and ensuring proper incubation conditions, storage, and assessment with expiry dates, consumption, and accountability. - Supervising and conducting research on various microbiological activities regularly. - Maintaining knowledge of research methods and performing manual operations on supplies. - Developing and maintaining validation protocols for environmental controls. - Conducting laboratory analysis on materials post sterilization. - D...

As the Quality Control Operations Manager in a WHO-GMP & ISO approved Tablets and Capsule manufacturing facility, your role involves the following responsibilities: - Performing HPLC and Dissolution analysis. - Reviewing and checking all Raw material, packing material, bulk and finish product specification, method of analysis, and all worksheets. - Reviewing and checking Different validation protocols like process, cleaning, analytical method. - Reviewing and checking Stability study and hold time study protocols. - Ensuring timely sampling and analysis of incoming materials, such as raw materials and packing materials. - Ensuring timely analysis of bulk, finish product, stability sample, an...

Preferred candidate profile : Having 10 - 12 yrs of experience in IPQA/Documentation's in QA. Well-versed in Change control, CAPA, Deviation, Mkt complain, Validation etc. Must have working exposure in Trackwise. Candidate from OSD only. Ready to relocate Sikkim . Interested candidates may apply at hr.plant@zuventus.com

Role & responsibilities Preparation and review of analytical method validation and method verification protocols and reports. Execution of analytical methods as per approved protocols. Coordination with cross-functional departments (QA, ADL, Production, etc.) for analytical method validation activities. Ensure compliance with Good Laboratory Practices (GLP) and Safety Guidelines in all laboratory operations. Ensure all laboratory activities are performed as per existing Standard Operating Procedures (SOPs) . Provide technical guidance and training to team members on SOPs and analytical techniques. Support the QA team by ensuring timely availability of audited and reviewed validation document...

protocol & reports of equipment / utility qualification Responsible for execution of equipment / utility qualification. process validation cleaning validation Annual Product review Validation Master Plan. Computer System Validation/ PLC validation Perks and benefits Food & Transportation, Bonus & Gratuity Separately

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace ...

Dear All, We are looking for an experienced professional to lead Analytical Method Validation activities for Finished Dosage Formulations (OSD) . The ideal candidate should have extensive experience in analytical development, method validation, and regulatory compliance for both domestic and international markets. Experience: 11-13 Years Location: Hyderabad(Dulapally) Key Responsibilities: Plan, design, and execute Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) activities for formulations as per regulatory guidelines (ICH, USP, EP, WHO, etc.). Review and approve Validation Protocols, Reports, Method Development Reports, and Specifications. Ensure method robustness, a...

Greetings from Kashiv Biosciences!!!! We are looking for Qualification, Validation and QMS Engineer for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities. Roles and Responsibilities: Responsible for Engineering compliance , Equipment Qualification, Validation and QMS activity. Timely escalation of any challenge bottle necks pertaining to engineering compliance to the management (site leadership team) to ensure proper planning and solutions. Representing as a Subject Matter Export of Engineering department in front of regulatory auditors. Responsible for engineering investigations pertaining to equipment failures and...

Roles and Responsibilities Conduct market complaint investigations, deviation management, and OOS/OOT handling according to established procedures. Ensure compliance with regulatory requirements through vendor qualification, equipment qualification, cleaning validation, water validation, injectable processing, and process validation. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Develop and maintain documentation related to quality control processes. Provide technical support for product testing and analysis. Desired Candidate Profile 4-8 years of experience in Quality Assurance (QA) or a related field within the pharmaceutical industry. ...

Responsible for conceptualization, design & development of new products Create 3D models and 2D drawings using SolidWorks & AutoCAD with proper GD&T application Prepare and manage Bill of Materials (BOM) & ensure accuracy during design releases Required Candidate profile Knowledge and hands-on exposure to manufacturing processes Press tools, injection molding, extrusion, machining, sheet metal fabrication, die casting Proficiency in SolidWorks, AutoCAD

Digital Design Engineer Job Title: Digital Design Engineer Experience: 0- 3 years Education: B.E/B.Tech/M.Tech in ECE, VLSI Responsibilities: Design and implement combinational and sequential logic Create synthesizable RTL for custom digital blocks Optimize designs for area, power, and performance Work with validation and test teams for post-silicon debug Requirements: Solid understanding of digital design principles Knowledge of finite state machines, timing, pipelining Basic exposure to FPGA or ASIC flows , DACs, PLLs, LDOs, bandgap references Perform schematic entry, simulations, and layout reviews Ensure proper matching, noise, and layout parasitic handling Work closely with layout and m...

Role & responsibilities Strategic & Leadership: Lead the QA Validation function for sterile injectables manufacturing facility. Develop, implement, and periodically review the Validation Master Plan (VMP) . Provide strategic direction for validation activities in line with corporate and regulatory requirements. Mentor, train, and supervise the validation team. Validation & Qualification: Oversee qualification of facility, cleanrooms, HVAC, water systems, equipment, utilities, and computerized systems . Manage process validation, cleaning validation, aseptic process validation (media fills), and hold-time studies for injectables. Ensure timely revalidation and continuous verification activiti...

C & Data Structures expertise (rating 8+/10) - Role: Development of Validation Operating System Debugging in Pre-Silicon (emulation/prototyping) Post-Silicon tasks: board bring-up, silicon validation

-Check documents like packing sheets, Temp Records, Logger readings -Exp with CAPA documentation -Monitor & maintain the temperature systems -Provide training & prepare training records -Branch visit & perform self inspection activity for branches Required Candidate profile -Male/Female willing to travel -Exp in food/pharma industry preferred -Exp in CAPA documentation is a MUST -Excellent verbal and written communication skills Perks and benefits PF, ESI, Mediclaim, Bonus, PL

Manages cGMP training, audits, and self-inspections. Reviews deviations, risk assessments, QA documents, and validation protocols. Prepares APQRs, updates quality manuals, ensuring compliance with QAMS, VMP, and quality systems. Required Candidate profile M.Sc or M.Pharm or BSc or BPharm 4 to 5 LPA 4-5 Years

You will be responsible for equipment validation and Quality Management System (QMS) related activities. Your main duties will include the preparation, review, execution, and compilation of validation protocols for in-house Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of all equipment and systems used in Injectable production at the Indore site. Additionally, you will ensure that Periodic Performance Verification (PPV) is conducted and approved according to the PPV schedule. As part of your role, you will be required to manage a team and allocate tasks effectively. You will also oversee the QMS system, including handling change control, ...

The ideal candidate for this position would be a Masters Graduate with hands-on experience in Microbiology, capable of working independently. You will be responsible for tasks such as media preparation, maintaining incubation conditions, storage, and creating Validation Protocols. You must also have proficiency in using microscopic instruments and possess strong Laboratory Skills. Your duties will include supervising and conducting research on various microbiological activities regularly. It is essential to stay updated on different research methods and perform manual operations on various supplies effectively. You will need to develop and uphold validation protocols for environmental contro...

This position is responsible for managing all Quality Control Operations of a WHO-GMP & ISO approved Tablets and Capsule manufacturing facility. Specific Responsibilities: To perform HPLC and Dissolution analysis. To review and check all Raw material, packing material, bulk and finish product specification, method of analysis and all worksheet. To review and check Different validation protocol like process, cleaning, analytical method. To review and check Stability study and hold time study protocol. To ensure for timely sampling and analysis of incoming materials, like raw materials, packing materials. To ensure for timely analysis of bulk, finish product, stability sample and validation sa...

Job Description: To address customer requirements in view of new product development and application requirements in adhesives and sealants. To develop and validate prototypes as per design requirements. To attend and solve the customer queries. To design and validate packing materials. Travel required through out India Preference: Should be located in Chennai and able to speak Hindi. Should have excellent communication and presentation skills- Mandatory Should have knowledge in automobile engineering. Candidates should be willing to travel and should have a valid Driving License. Candidates having experience in Mechanical / Automobile / Chemical / Industrial in the department of application...

Ensure compliance with GMP & regulatory standards, oversee quality systems, audits & validations, manage QA team, review batch records, handle deviations/CAPA, support regulatory inspections, ensure product quality & safety across manufacturing.

-Check documents like packing sheets, Temp Records, Logger readings -Exp with CAPA documentation -Monitor & maintain the temperature systems -Provide training & prepare training records -Branch visit & perform self inspection activity for branches Required Candidate profile -Male/Female willing to travel (PAN INDIA) -Exp in food/pharma industry preferred -Exp in CAPA documentation is a MUST -Excellent verbal and written communication skills Perks and benefits PF, ESI, Mediclaim, Bonus, PL