670 Process Validation Jobs - Page 4

Prepare and review Batch Manufacturing Record Prepare and review Batch Packaging Record Prepare Stability Process Validation Protocol Hold Time Study SMPC/ Insert CAPA SOP Preparation

Job Responsibilities: Supervise and coordinate the activities of the filling line team, including operators, technicians, and other personnel. Ensure the efficient and compliant operation of vial washing, depyrogenation tunnel, and filling machines (Groninger and BOSCH). Enforce adherence to cGMP guidelines, national regulations (Schedule M), and international standards (WHO) across all filling operations. Oversee the training and development of filling line personnel on aseptic techniques, equipment operation, and documentation practices. Monitor and evaluate the performance of team members, providing regular feedback and conducting performance reviews. Create and maintain staff schedules t...

Job Title: NPI Engineer Electronics Manufacturing Department: Manufacturing Engineering Reports To: NPI Manager / Engineering Manager Job Summary: The NPI Engineer plays a key role in transitioning new electronic products from design to mass production. This position is responsible for managing and optimizing the introduction of new products into the manufacturing process, ensuring readiness across engineering, materials, and production teams. The ideal candidate will have a strong background in electronics manufacturing, process development, and cross-functional coordination. Key Responsibilities: New Product Introduction (NPI) Management: Lead and coordinate the introduction of new electro...

Responsible for formulation and process development of Oncology and hormonal products of oral dosage forms (Oral solid and Oral liquid formulations). Troubleshooting and problem-solving of unresolved or new formula issues. Design and execute formulation trials and evaluate stability data to finalize formulation composition. Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches. Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS etc. Support the manufacturing of exhibit/submission batches per regulatory requirements....

Job Receiving user indents, verifying with approved budget, and floating RFQ to the vendor (minimum 2 to 3 vendors). Preparing a worksheet to validate supplier quotes based on cost, quality, OEM, and delivery lead time Knowledge of SAP for PO release. Create PSR and follow the PSR approvals stage-wise. PO release. Monitoring material delivery against committed vendor dates. Coordinating with the maintenance team for installation and commissioning. Coordinating with the logistics team. Coordinating material in warding and acceptance, and vendor payment. Asset management and handling the Audits Generating and circulating reports to management. Relevant Experience: Mechanical and Electrical, Co...

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...