28 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: 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

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