38 Validation Protocol Jobs - Page 2

Role & responsibilities: The candidate would be required to take on the responsibility of ensuring quality product and production efficiency. Some of the key responsibilities that may be given are: 1. Review and maintain batch records, SOPs and quality documentation. 2. Conduct in-process checks and ensure GMP compliances. 3. Perform internal audits and assist in external audits (FDA, WHO, ISO, etc.) 4. Handle deviations, CAPA, change controls, and OOS investigations. 5. Ensure data integrity and documentation as per regulatory requirements. 6. Coordinate with QA, QC and Production teams to maintain quality standards. 7. Carry out validations and risk assessments Preferred candidate profile:...

JD Collaborate with cross-functional teams on equipment qualifications and IQS. Ensure IT compliance through validation processes. Develop computer system validation plans and protocols. QMS candidate shud b frm pharma industry gud communic skills. Cafeteria Office cab/shuttle Accessible workspace Health insurance Provident fund Annual bonus

Roles and Responsibilities Ensure compliance with quality management systems (QMS) through implementation, maintenance, and continuous improvement of ISO documentation. Prepare SOPs for various processes such as BMR, CAPA, Change Control, Cleaning Validation, etc. Conduct qualification testing and validation protocol execution to ensure product quality and regulatory requirements. Develop and maintain accurate records of test results, reports, and certificates related to quality assurance activities. Collaborate with cross-functional teams to identify areas for improvement in quality control processes. Desired Candidate Profile 5-10 years of experience in pharmaceutical industry with experti...

We are seeking an experienced professional to lead Quality Assurance while supporting Regulatory Affairs activities at our API manufacturing facility. The ideal candidate will be responsible for ensuring overall compliance with QMS and regulatory standards, managing validations and audits, and maintaining product quality in line with international guidelines. Key Responsibilities: Lead The implementation and oversight of the site Quality Management System (QMS), including SOPs, validations, and document control. Conduct and manage internal and vendor audits; review deviations, non-conformances, and ensure timely CAPA execution. Review and approve Master Production Records, Batch Production R...

Review and approve validation protocols (IQ/OQ/PQ), reports, and related documentation for manufacturing equipment, utilities, and processes. Provide QA oversight during the planning and execution of process validation and cleaning validation activities. Ensure all validation activities are conducted in accordance with current Good Manufacturing Practices (cGMPs), company policies, and industry standards. Participate in risk assessments (e.g., FMEA) to support validation strategy development. Support investigations and change controls related to validated systems or processes. Collaborate with Manufacturing, Engineering, QC, and Regulatory Affairs to ensure validation deliverables are aligne...

We are specifically opening this position to people in an Assistant Manager or Team Leader Role who think they are ready for the Next Challenge! The person filling this role should be meticulous and experienced to lead method development, validation, stability studies, and technology transfer activities at Synnat Pharma , Visakhapatnam. This role involves close collaboration with R&D, QC, and Regulatory teams, supporting product development and compliance with global pharmaceutical standards. The ideal candidate will have strong analytical expertise, leadership skills, and a commitment to regulatory compliance and continuous improvement. Responsibilities: Develop, optimize, and validate anal...

1. Preparation of Annual/Periodic Product Quality Review (APQR/PQR) 2. Preparation of finished product specification (Tablet, External preparations & Injection) 3. Preparation of Protocol and Reports of PROCESS VALIDATION Batches. 4. Handling of Incidents, Deviation, CCP, OOS, OOT and Material Rejections 5. Issuing BARCODES for new Registered products in coordination with regulatory department. 6. Working Hands on MARKET COMPLAINTS and CAPA. 7. Preparation of Master Formula Record (MFR) and Preparation Of (SOPs). 8. Preparation of EQUIPMENT QUALIFICATION documents i.e. IQ, OQ, PQ protocol and Reports during Installation of New Instruments/ Equipments. 9. Identification of Hazard and Calculat...

Key Responsibilities:** - Conduct thorough testing and validation of [products/processes, e.g., software applications, pharmaceutical formulations, or manufacturing processes] to ensure compliance with quality standards. - Develop and execute QA test plans, protocols, and reports. - Identify, document, and track defects, ensuring timely resolution. - Collaborate with cross-functional teams to maintain quality throughout the product lifecycle. - Ensure adherence to regulatory standards (e.g., ISO, GMP, or other relevant certifications). - Contribute to process improvements and quality assurance strategies. **Skills Required:** - Strong knowledge of QA methodologies, tools, and processes. - Fa...

Role & responsibilities protocol Preparation, review and execution for plant qualification preparation of process validation protocol, preparation and compilation of validation report co-ordinate for 3rd party calibration risk assessment preparation annual product review QMS, Change control, DEviation Preferred candidate profile B.Pharma/M.Sc with minimum 6-8 yrs experience in QA. candidate must have exposure of working in regulatory pharma plant.

Lead end-to-end product development projects in alignment with customer requirements and company objectives CAD tools used; manage BOM, DVP, and APQP documentation Drive prototype development, testing, and validation activities for new products Required Candidate profile Strong understanding of APQP, PPAP, FMEA, GD&T Must Have Experience in Sheet Metal Industry Experience with Tier 1 & 2 automotive suppliers is highly preferred Proficient in SolidWorks, AutoCAD

Responsibilities: * Ensure compliance with regulatory requirements through quality control measures * Conduct process validations, cleaning verifications & change controls * Prepare validation protocols & reports

Greetings from Kashiv Biosciences!!!! We are looking for 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 , 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 ensure for proper root cause identifi...

Role & responsibilities Ensure all Raw Material, Chemical and Packing Material received are tested and released as per the SOP Analyze and approve, if rejected create the discrepancy note, send a copy to Stores and Purchase Dept. and reject the material in SAP Ensure compliance of quality plan is maintained for all in-process stages To initiate corrective actions request for all non-conforming material at incoming inspection, in-process inspection and FG inspection Ensure all equipments and processes are calibrated and validated respectively Ensure Finished Product testing is carried out as per customer and regulatory requirements, review and authorize the Certificate of Analysis To manage, ...