590 Process Validation Jobs

Job Title: New Product Development Trainer Location: Remote Job type: Part -time Job Summary: We are seeking an experienced NPD Trainer with over a decade of hands-on expertise in medical device design, product development, validation, and regulatory compliance . The Trainer will be responsible for designing and delivering structured training programs to upskill engineers, technicians, and project managers in end-to-end new product development processes from concept to commercialization. The ideal candidate should possess strong technical depth, familiarity with ISO 13485, FDA 21 CFR Part 820, and Design Control requirements, and the ability to translate complex product development concepts ...

Greeting from HCLTech..! We are looking candidate for BIW Robotic Simulation Engineer Exp - 5 to 10 Yrs Location - Bangalore Software Skill set - Delmia V5 Role & responsibilities Knowledge of BIW Experience in robotic simulation for Automotive OEMs Awareness of OEM robotic simulation standards, preferably Mercedes Benz Product, process and layout validation for Bodyshop Experience in kinematics Generation of OLP Experience in BIW tool design desirable Exposure to any 3D CAD software interested candidate, apply here or share your resume to venkateshp@hcltech.com

Role & responsibilities : We are looking for multiple positions from IPQA to QMS aspects, experienced between 2 years to 12 years in OSD formulation QA with B.Pharma/M.Pharma background. Preferred candidate profile : candidates having exposures on IPQA, line clearance, BMR BPR Review, CAPA management, Market compliant investigation, Change control, validations and qualification, vendor management and audit compliances.

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Job Description: Require experience in IPQA, IPQA (API), Qualification (API), Validation (API), Analytical QA, APQR, Stability Studies, regulatory affairs, OOS investigation, Risk Assessment, Market Complaint, QA Documentation, Exposure in QMS, Deviation, CAPA etc with Trackwise system. Qualification - B.Sc./M.Sc./ B.Pharma/ M.Pharma. Experience - 04 to 09 Years. Role & responsibilities Preferred candidate profile The candidate from API background Only to apply. Send CV with Sub : Forwarding CV for position of QA dept to jagpal.dewal@ipca.com

Urgent Hiring || Quality Assurance Officer || Mumbai Profile : Quality Assurance Officer Experience : Min 3 years CTC : upto 4 LPA (Depend on the interview) Location : Tajola Mumbai Roles and Responsibilities: Issuance of all documents related to QMS, BMR, ECR, Specification, MOA, TDS, formats & SOPs controlled copy. Preparation, review and distribution of SOPs Review Batch manufacturing Record (BMR), Equipment cleaning record (ECR) etc. Handling of Change Control Systems, out of specification, deviations etc. Preparation of Annual product quality review. Preparation & monitoring of process validation activity. Preparation & Monitoring of Cleaning validation activity. Handling of pre - dispa...

Role & responsibilities 1. Responsible for monitoring of basic norms of cGMP, ALCOA+ Principle, data integrity, GDP & to maintain his personal health hygiene. 2. To co-ordinate and carry out the self inspection and maintain records of self inspection report, schedule, auditor List, Auditor Qualification, compliance status etc. 3. To prepare, review and implement various protocol and report like Process Validation, Cleaning validation, HVAC validation, Temperature Mapping (Area / Equipment), Equipment / Instrument / System Qualification, Hold time Study. 4. To execute various activity like Process Validation, Cleaning validation, HVAC validation, Temperature Mapping (Area/Equipment), Equipmen...

The ideal candidate brings 2 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Strengthen QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA,...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 8 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Le...

Quality Assurance (QA) based in Latur The ideal candidate brings 0-1years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Strengthen QMS: author/re...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat The ideal candidate brings 5 to 8 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/...

Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5-8 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/...

Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improveme...

Role & responsibilities 1. Responsible for monitoring of basic norms of cGMP, ALCOA+ Principle, data integrity, GDP & to maintain his personal health hygiene. 2. To handle IPQA team, assign shift of IPQA and monitor routine IPQA activities. 3. Need base, carried out the line clearance activity, In-process checks and Sample collection at different stages of processing. 4. To take round at Stores, Manufacturing, Primary Packing, Secondary Packing, BSR, Scrap Yard and other areas. 5. To Review BMR/BPR request and Material requisition and approve or reject request in SCM for stores, Packing, Production and BSR. 6. To approve Packing slip, MRN, Bar-coding, batch approval in Propix software and to...

Job Role: Data Management Job Location: Kochi Shift: APAC Role Purpose: The Data Management Analyst will be responsible for managing, validating, and maintaining high-quality security, pricing, and index data across the firm's global Data Management platform. The role ensures data integrity, supports business operations, and contributes to process improvement and automation initiatives while interacting with multiple global stakeholders. Key Responsibilities: Setup and maintain security, index, and price data on the global Data Management platform. Perform daily quality checks on security master, index, and pricing data. Monitor and control data feeds received from various external and inter...

Job Role: Data Management Job Location: Kochi Experinece - 6 months to 2 years Shift: APAC Role Purpose: The Data Management Analyst will be responsible for managing, validating, and maintaining high-quality security, pricing, and index data across the firm's global Data Management platform. The role ensures data integrity, supports business operations, and contributes to process improvement and automation initiatives while interacting with multiple global stakeholders. Key Responsibilities: Setup and maintain security, index, and price data on the global Data Management platform. Perform daily quality checks on security master, index, and pricing data. Monitor and control data feeds receive...

Roles and Responsibilities Conduct BPR review, BMR review, Change Control, Cleaning Validation, Deviation investigation, IPQA activities, Process Validation, QMS implementation, and Quality Assurance for Formulation Sterile Injectables. Ensure compliance with regulatory requirements and company policies. Collaborate with cross-functional teams to resolve quality issues and improve processes. Develop and maintain documentation related to quality control procedures. Participate in audits and inspections conducted by regulatory authorities. Desired Candidate Profile Strong understanding of Good Manufacturing Practices (GMP), Current Good Laboratory Practice (cGMP), and Quality Management System...

The QA Executive ensures implementation and maintenance of Quality Assurance systems as per GMP and GDP standards, maintaining documentation accuracy, adherence to procedures, and continuous improvement in product quality and reliability.

Design QE methodology and test approaches that validate features developed by Agile / Scrum teams and ensures the accuracy of the requirements Drive, scope, design and code automated tests Create automation best practices Participate in our Agile process by being an active contributor in daily standups, sprint kick-offs, demonstrations, and retrospectives Make recommendations for improvements in how we engineer our products. Perform manual and automated QE processes for new releases, and for routine maintenance. Report defects and testing status Design test environment in QE Lab Simulate real-world deployments of the products, and reproduce customer issues Required education Bachelor's Degre...

Role Overview: As a Quality Assurance professional at our company, your primary responsibility will be to ensure the online documentation of batch manufacturing and batch packing records. You will also be in charge of carrying out in-process checks of pre-determined process parameters as per BMR/BPR and withdrawing in-process/FP/Reference & stability samples following SOP. Additionally, monitoring the environmental condition of critical areas and reviewing & approving QA SOPs will fall under your purview. Key Responsibilities: - Ensure online documentation of batch manufacturing and batch packing record - Carry out in-process checks of pre-determined process parameters as per BMR/BPR - Withd...

ENURANCE TECHNOLOGY LTD. Position Title: Process Development Engineer Reports to: Plant Head/ Process Development Manager Location: Aurangabad , Maharashtra Team size: 2~3 Direct Repartees. Experience: 8 to 10 Years A process development engineer designs, implements, and optimizes manufacturing processes to improve efficiency, product quality, and cost-effectiveness, ensuring safety and compliance with industry standards Candidate from Brakes or ABS back ground is preferred. Analyses new Product feasibility, cycle times estimation, machines & tools planning, tools/fixtures cost estimation, design & participation in DVP, execution. Designing of tools, gauges and machining fixtures & CNC machi...

Responsibilities: Prepare and review Batch Manufacturing Record & Batch Packaging Record Prepare Stability Process Validation Protocol Hold Time Study SMPC/ Insert Collaborate with cross-functional teams on CAPAs and process improvements.

SHOULD YOU ACCEPT THIS CHALLENGE Pure Storage builds the industry s most innovative, easiest to use, high-performance, and highly available portfolio of products that are designed for the most demanding mission critical applications. While we deliver a hardware storage array, over 90% of our engineering staff are software engineers. Our customers are the most important part of our business and they love FlashArray and FlashBlade for their simplicity of management, the constant flow of new and exciting upgrades, and ability to live on the cutting edge of technology while never taking downtime, ever. Most recently, we extended the value of our capabilities into the cloud with CloudSnap and Clo...

Role & responsibilities 1. Responsible for review of User Requirement Specification, Design Qualification, FAT Protocols, SAT Protocols, Installation Qualification, Operational Qualification, Performance Qualification Protocols and reports. 2. Responsible for preparation of commissioning protocols, FAT, SAT and associated risk and GAP analysis documents. 3. Responsible for preparation of facility, equipment, area qualification protocols, reports and execution. 4. Accountable for ensuring the compliance the qualification activities in -line with global quality/regulatory requirements. 5. Responsible for Engineering compliance and review of Engineering department SOPs, PMP calibration and faci...

Job Title: Deputy Manager- Formulation Location: Govandi, Mumbai Department: Corporate Quality Assurance Qualification, Experience and Technical Competency: 1. Master’s Degree in Pharmacy or Science or equivalent scientific field. 2. Minimum 10 years experience in Pharmaceutical Industry (Strong background of Formulation industry with 2 to 3 years experience in Quality Control.) 3. Work experience in Regulatory Sites (USFDA, MHRA, EU GMP) 4. Knowledge of current Good Manyfacturing Practices (cGMP), Quality Management Systems (QMS) and regulatory guidelines. Key Requirements: Responsible for Quality Functions across Own Sites and Contract Sites with adherance to cGMP, Regulatory standards and...