679 Process Validation Jobs - Page 12

Dr. Reddys is looking for Manufacturing Scientists or senior scientists specialized in cell therapy (CAR-T) programs to join their Manufacturing facility team. As a Manufacturing Scientist, you will collaborate with Research and Product Development teams to support GMP Manufacturing operations, Technology transfer, quality assessments, and process validation of the CAR-T process for various Cell therapy programs. Your responsibilities will include designing and executing experiments to develop robust manufacturing processes for cell therapy products, leading and training a team of cell process scientists/engineers, managing T-cell culture and differentiation, documenting experimental procedu...

As a Senior QA Officer, your role will involve various responsibilities to ensure quality assurance within the API pharma industry. You will be tasked with issuing Batch Manufacturing Records, equipment cleaning records, logbooks, and analytical reports for raw materials, finished products, and packing materials. Additionally, you will assist in the preparation of SOPs for different departments and conduct plant rounds to verify documents according to cGMP and GLP norms. Line clearance activities for manufacturing and packaging, issuing deviation forms, change control forms, and handling customer complaints will also be part of your duties. You will review and verify analytical and Batch Man...

We are seeking a dedicated Senior Validation position at a reputed pharmaceutical organization based in Ahmedabad. Experience : 5+ Years Qualification : B.Pharma Role & responsibilities Thermal mapping for mixing/holding vessels, steam sterilizers (autoclaves), terminal sterilizers, depyrogenation tunnels, lyophilizers, filling machines, cold rooms, and cleanroom areas, Media fill Isolator and HVAC system ,Process validation and equipment Utility : compressed air, nitrogen, and steam quality testing. Change control, CAPA, and process understanding. Protocol, validation report, and SOP preparation , Cleaning validation. Interested candidate with the required qualification and experience are e...

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Data Warehouse ETL Testing Good to have skills : NA Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with team members to understand project needs, developing application features, and ensuring that the applications function seamlessly within the existing infrastructure. You will engage in problem-solving discussion...

Job Title: Assistant Manager In-Process Quality Assurance (IPQA) Department: Quality Assurance Location: Hyderabad, Jeedimetla Reporting To: Manager Quality Assurance / Head Quality Job Purpose: To ensure that all in-process operations are monitored and compliant with applicable cGMP, SOPs, and regulatory requirements. The IPQA Assistant Manager is responsible for in-line quality checks, deviation control, batch record review, and timely escalation of non-conformities during manufacturing and packaging processes. 1. In-Process Quality Monitoring Supervise and execute IPQA activities during manufacturing and packaging. Perform real-time line clearance, process checks, and verification. Ensure...

As a Manager Quality Assurance at Syngene International Ltd., you will be responsible for ensuring compliance with all national and international regulatory agency requirements related to API manufacturing. Your role will involve evaluating and approving vendors/subcontractors, reviewing and approving various reports such as SOP, analytical method validation, and calibration reports, and coordinating review meetings to maintain the effectiveness of the quality system. You will be expected to have a strong understanding of regulatory requirements from agencies such as ICH, USFDA, WHO Geneva, PMDA Japan, and others. Additionally, you will play a key role in the approval of protocols and report...

As a Manager 1 at Sun Pharma Laboratories Ltd in Guwahati - Regulatory Affairs, your primary responsibilities will include: - Facilitating the harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. - Reviewing documents related to Quality Management System (QMS) & Compliance. - Ensuring compliance of the Quality Management System. - Participating in Site Training Programs as per site and Global Quality Standards requirements. - Submitting Dossier documents after review against requests received from Corporate regulatory affairs. - Responding to queries related to submitted dossiers as per requests from...

We are seeking a detail-oriented Deputy Manager Quality Assurance to support robust QA operations and also some Regulatory Affairs functions at Acharya Group's API manufacturing unit. This role focuses on maintaining our Quality Management System (QMS) for API production, ensuring cGMP and regulatory compliance for EU, USFDA, PMDA, and other Major Regulatory Regions. Key responsibilities include participating in batch release and continuous improvement; overseeing validation of API manufacturing processes, equipment, and analytical methods, managing deviations, conducting investigations, and implementing CAPA plans. Candidates must have prior experience in Quality Assurance within API manufa...

Project Role : Data Platform Engineer Project Role Description : Assists with the data platform blueprint and design, encompassing the relevant data platform components. Collaborates with the Integration Architects and Data Architects to ensure cohesive integration between systems and data models. Must have skills : Graph Databases Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : BE Summary :As a Data Platform Engineer, you will be responsible for assisting with the blueprint and design of the data platform components. Your typical day will involve collaborating with Integration Architects and Data Architects to ensure cohesive integration bet...

Job Overview Manufacturing engineer is responsible for preparing the process sheets, tool design, establish overall strategic goals & objectives of Manufacturing Engineering in alignment with organizational goals.This role will be an individual contributor, which reports to MGR I MFG & Process development engineer Responsibilities: Analyze new technology and manufacturing processes. Plan and assess the feasibility of new and running projects. Ensure good interfaces between Production, Production Planning, Engineering, QC and other functions. Plan, design, and monitor manufacturing improvement processes using work study techniques. Ensure Day to day accountability & support Production team to...

Job Title: Manager Quality Assurance (QA) Company: Global Calcium Pvt. Ltd. Location: Unit III – Hosur, Tamil Nadu Experience: 10+ years Qualification: B.Pharm / M.Pharm / M.Sc or equivalent Job Description: We are looking for an experienced Manager – QA to lead our Quality Assurance team at Global Calcium Pvt. Ltd., Unit III (Hosur). Key Responsibilities: Lead Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements. Manage validation and qualification of equipment, utilities, and processes. Ensure audit readiness and compliance with regulatory agencies (USFDA, EU, WHO, MHRA). Review and approve SOPs, protocols, and reports related to validation and qua...

1. Quality Systems & Documentation: Develop, implement, and maintain GMP-compliant QMS. Oversee change control, deviations, CAPA, incident management, risk assessment, and market complaints. Ensure GDP compliance in all QA documentation, including SOPs, batch records, specifications, and MOAs. Prepare and revise SOPs, distribute and retrieve old versions, and manage documentation control. Handle QMS activities like return goods, non-conformities, and investigation reports (5-Why, 6M method). 2. Validation & Qualification: Review and approve URS, IQ, DQ, OQ, and PQ protocols and reports. Manage process validation, cleaning validation, equipment qualification, and facility validation. Conduct ...

Job Title: Quality Engineer Plastic Injection Molding Location: Oragadam, Chennai, Tamil Nadu, India Employment Type: Full-Time | On-site Experience Required: 812 years About our Client Our Client is a global leader in precision manufacturing , specializing in high-volume, micro-precision components for electronics, automotive, industrial automation, and energy infrastructure . Our Oragadam (Chennai) facility supports advanced plastic injection molding and EMS operations , serving some of the worlds most innovative technology brands. Role Summary The Quality Engineer Plastic Injection Molding will be responsible for ensuring that all plastic molded components meet the highest standards of qu...

As the Quality Officer, your primary responsibility will be to perform routine QC laboratory analysis on raw materials, in-process materials, finished products, stability samples, and process validation. You are expected to exhibit proficiency in conducting various physical and chemical analyses utilizing a diverse range of laboratory equipment. Collaboration, teamwork, accountability, and the capacity to multitask are essential qualities that you must possess to thrive in this dynamic and fast-paced work environment.,

Dear All, Greetings from Aizant Drug Research Solutions!! We are looking for a motivated professional with strong expertise in Process Validation (QA Formulations) to join our Quality Assurance team. The ideal candidate should have hands-on experience in planning, executing, and documenting cleaning validation activities as per regulatory requirements. Experience: 3-5 Years Location: Hyderabad(Dulapally) Department: Quality Assurance(Formulations) Key Responsibilities: 1. Co-ordinate for Review and approve of departmental SOPs/Guidelines/Operating instructions. 2. To supervise transfer of batches from lab scale to commercial batches at the shop floor and to ensure quality system compliance. ...

We are looking for a meticulous Sr. Executive - Production to spearhead production activities and ensure adherence to stringent quality standards at Synnat Pharma Private Limited. As Sr. Executive - Production, you will play a pivotal role in managing batch manufacturing records, equipment compatibility, and various validation protocols, including process, cleaning, blending, drying, and micronization. The ideal candidate will be adept at preparing master formula records, quality equivalence reports, and standard operating procedures, while also taking the initiative for change controls and performance qualifications. This role demands a strong understanding of QMS activities, internal and e...

Role & responsibilities Manage end-to-end technology transfer of OSD formulations to commercial sites. Drive process validation, optimization, and evaluation in line with regulatory standards. Ensure accurate documentation and compliance with global regulatory requirements. Coordinate cross-functional activities and respond to regulatory deficiencies. Preferred candidate profile Qualification: M.Pharm Experience: 1015 years in formulation technology transfer (OSD). Strong expertise in process validation, optimization, site transfers & commercial validation

MNC Company Job Opening: Development Engineer Contact - 9356395439 Email - punejob2025@gmail.com Location: Talegaon MIDC , Navlakh Umbre, Maharashtra, India. Experience Level: 3-5 Years Industry: MNC Korean Based Automotive Manufacturing Company Salary (3 to 3.5 LPA) B.E. / B.Tech / DIPLOMA. in Mechanical / Automobile / Production Engineering (or equivalent). 062 years of relevant experience in product / component development. Exposure to APQP, PPAP, DFMEA, and validation processes preferred. Key Responsibilities Work on development of new products, tools, or processes as per project requirements. Collaborate with design, testing, and manufacturing teams to ensure feasibility and quality. Co...

The Associate, Regulatory Affairs is responsible for supporting regulatory efforts related to the submission of supplemental ANDAs, ANDA Annual Reports, Drug Listing, SPL/PLR (labeling), and other regulatory compliance matters to assist the company's approved product portfolio, both internally and externally. Key responsibilities include: - Compiling and submitting Post Approval Supplements such as PAS, CBE-0, CBE-30. - Preparing, reviewing, and submitting amendments and supplements for assigned products. - Preparing, reviewing, and submitting responses to the Agency's queries for assigned products. - Compiling and submitting Global Annual Reports. - Reviewing stability protocols and reports...

You should possess a B. Pharmacy/M. Pharmacy (Pharmaceutical Analysis and Quality Assurance) or M. Sc. in Chemistry or equivalent with 5 to 8 years of experience in formulation pharmaceutical industries in the quality control department. In this role, you will be responsible for handling day-to-day activities related to sampling, testing, and release of active ingredients, inactive ingredients, packaging materials, in-process and finished products, stability samples. Your primary responsibilities include ensuring that all activities within the quality control section meet current applicable cGMP guidelines and regulatory expectations. You will be accountable for ensuring timely sampling, ana...

addii biotech is looking for Assistant Manager For QC - EXP-10-12 YRS to join our dynamic team and embark on a rewarding career journey Ensuring company policies are followed. Optimizing profits by controlling costs. Hiring, training and developing new employees. Resolving customer issues to their overall satisfaction. Maintaining an overall management style that follows company best practices. Providing leadership and direction to all employees. Ensuring product quality and availability. Preparing and presenting employee reviews. Working closely with the store manager to lead staff. Overseeing retail inventory. Assisting customers whenever necessary. Organizing employee schedule. Ensuring t...

We are looking for a meticulous Asst. Manager Production to lead production activities at Synnat Pharma Private Limited, ensuring seamless API manufacturing operations and adherence to the highest quality standards. As Asst. Manager Production, you will play a pivotal role in overseeing daily production activities, monitoring validation batches, and ensuring compliance with cGMP guidelines. Your responsibilities will include the preparation and review of production-related documents, coordination with cross-functional teams, and active participation in internal and external audits. You will also be responsible for identifying and resolving operational gaps, managing deviations and Out-of-Spe...

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...

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/...

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/...