886 Process Validation Jobs - Page 6

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...

Preventive maintenance & calibration of equipment and systems. Knowledge of Process and Cleaning Validation (QMS) Experience in handling regulatory affairs and be able to prepare Dossier for ROW matkets Handling RFIs FROM PHARMA FORMULATIONS ONLY

As a candidate for the position, your role overview will include the following responsibilities: - Responsible for maintaining self-hygiene. - Preparation, review, revision, control, and implementation of standard operating procedures in the sterile manufacturing department. - Preparation and review of master production documents. - Preparation and review of protocols and reports as required. - Handling document management including BMRs, BPRs, and master SOPs. - Managing change control, deviations, CAPA, investigations, etc. - Overseeing manufacturing, filling & sealing, labeling, and packing operations. - Creating monthly and daily production planning based on material availability. - Gene...

As a Machine Maintenance Technician at our company, your role will involve the following key responsibilities: - Diagnostic & troubleshooting in machine related to Quality, Rejection, process improvement. - Programming in CNC machines like turning, grinding, induction hardening, hobbing & VMC. - Process validation & Fixtures calibration. - Special process validation (Induction Hardening). - Conducting Why Why analysis of under process downtime and implementing countermeasures. - Planning & executing tool cost reduction action plans. - Collaborating with customers to improve QA network & implement Poka yoke. - Implementing Kaizens for cost-saving initiatives. - Preparation/updation of PPAP do...

As a Line Clearance Officer, your role involves ensuring proper line clearance activities before commencing various operations like dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. You will be responsible for conducting process validation, cleaning validation/verification, hold time study, media fill, and routine batch sampling as per protocol/SOP. Additionally, you will review executed BMRs and BPRs and perform in-process tests at different stages as per batch document/SOP. Your key responsibilities will include: - Reviewing environment monitoring and water trends - Reviewing different types of planner and calibration certificates - Receiving necessary resourc...

You will be responsible for overseeing the Quality Assurance department of the Pharmaceutical formulation unit. Your key responsibilities will include: - Demonstrating a minimum of 10 to 15 years of experience in QA within the Pharmaceutical industry - Possessing knowledge of Regulatory requirements and documentation such as water validation, process validation, etc. - Conducting training sessions for junior staff on incident management, change control, CAPA, and other relevant topics - Demonstrating expertise in WHO GMP / cGMP standards Your qualifications should include: - M.Pharm / B.Pharm / M.Sc. degree - Minimum of 10 to 15 years of experience in QA within the Pharmaceutical formulation...

Responsibilities: 1. Conduct audits, QMS management, process validation, BMR review, BPR review. 2.Ensure IPQA compliance, prepare SOPs, perform vendor qualifications. 3. Quality Management System (QMS) Oversight 4. Training and Leadership Health insurance Provident fund

Roles & Responsibility Diagnostic & troubleshooting in machine related to Quality, Rejection, process improvement. Programming in CNC machines like turning, grinding, induction hardening, hobbing & VMC Process validation& Fixtures calibration Special process validation (Induction Hardening). Why Why analysis of under process downtime and countermeasure implementation. Planning & execution of tool cost reduction action plan. Execution of customer to reduce to improve QA network & Poka yoke. Implementation of Kaizens for cost saving. PPAP documents preparation/updation & tool & fixtures sheet, Control Plan Requirements Hands on experience in induction hardening machine troubleshooting Diploma ...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Responsible role-holder in production department responsible for planning,exec...

Job Overview TE Connectivity's Manufacturing Engineering Teams are process leaders for stamping, molding or assembly related topics, ensuring the processes are running at optimum levels for quality and output They are experts in mold tooling, die tooling, machining, and assembly techniques, possessing extensive knowledge of the associated manufacturing processes which may include the optimization and standardization of stamping / molding / assembly or other processes within the manufacturing environment Manufacturing Engineering Teams enable the TE business unit plants to reach TE Operating Advantage (TEOA) requirements, roll out Centers of Excellence (COE), Best Demonstrated Practices (BDPs...

Role & responsibilities Lead implementation and continuous improvement of ISO 13485-compliant QMS. Ensure compliance with FDA QSR (21 CFR 820), EU MDR, and other applicable regulatory requirements. Manage internal and external audits (FDA, notified bodies, ISO, etc.). Oversee document control, change control, and quality records management. Approve quality documentation, SOPs, DMRs, DHFs, and technical files. Lead root cause investigations and implement effective corrective and preventive actions. Manage nonconformances and track resolution effectiveness. Approve and audit suppliers and subcontractors. Ensure incoming materials and components meet specifications. Collaborate with production ...

Process Engineer - Automation & Robotics responsibilities: Understanding client needs and offering solutions and support; answering potential client questions and follow-up call questions; responding to client requests for proposals. Support in writing new business proposals and technical documentation. Prepare cycle time calculations, line balancing, efficiency study, capacity planning & analysis. Prepare conceptual designs, tentative BOM & technical responses. Keep prospective client database update along with proposal MIS. Communication and co-ordination with design team. Creating informative presentations; presenting and delivering information to potential clients at client meetings, ind...

Roles and Responsibilities Responsible for overall Quality System Review & Improvements Handling and control of Non-conforming products. Responsible for review & approval of key Quality System Procedures, Standard Operating Procedures & other Master Documents. GAP Analysis of the process and products. Identifying the scope of improvement based on trend analysis. Putting forward the suggestions for improvements to the Management. Participation in audits, compliance and Tracking of Audit Compliances/Status. Review & closeout of Change Controls, Deviation Complaints & CAPA. Participating in Impact assessment, investigation & approval of deviations. Review & Approval of change controls, Deviatio...

We are looking for a Process Validation Engineer with strong experience in sterile pharmaceutical environments. The ideal candidate must have hands-on experience in validation activities and ensure compliance with regulatory standards. Office cab/shuttle Health insurance Annual bonus Provident fund Food allowance

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

As a Laboratory Technician at Phoenix Conveyor Belt India Private Ltd, your responsibilities include: - Performing basic laboratory tasks such as buffer preparation, supply stocking, inventory and ordering, equipment maintenance, and updating associated logs - Ensuring that all procedures and processing areas are clean and organized - Preparing and conducting testing of nanomaterials according to SOPs to release acceptable products - Conducting testing for product validation and process validation on existing products and publishing data accordingly - Assisting the Operations department in performing process qualifications and validations for procedures and equipment - Maintaining the produc...

Role Overview: As a Senior Hardware Engineer at our startup product development firm, you will be responsible for developing innovative solutions at the system level and conducting detailed electronic design work. This client-facing role will provide you with the opportunity to collaborate with world-class engineers to create novel products that push boundaries and may not yet exist in the market. Key Responsibilities: - Design, analyze, and validate electrical hardware, including integration with complex mechanical components, for low volumes through mass production. - Manage, mentor, and direct cross-disciplinary teams to conduct research, brainstorm, prototype, test, analyze, document, an...

Perform gap assessment and conduct remediation of documents with stakeholder inputs. • Good understanding on the manufacturing specific QMS documents for Class-I, II and III medical devices. •Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA. •Creation/modification of process flows within the Manufacturing/Service Departments. • Development and maintenance Manufacturing/Service Work Instructions and related documents. • Creation/modification of fixtures, tooling, equipment and systems to support operations. • IQ, OQ, and PQ of fixtures, tooling, ...

ZS is looking to hire a Business Technology Solutions Associate Consultant in ZS' Supply Chain and Manufacturing practice with experience in pharmaceutical drug development and tech transfer. The primary responsibility of this role is to deliver projects in the pharmaceutical CMC development area for ZS clients. The successful candidate will leverage their expertise in using and implementing digital laboratory systems such as Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), and ensuring GLP-compliant solutions to support CMC workflows; along with supporting Digital and Technology advisory, Product and Platform development and Data, Analytics and AI implementa...

Process Review & Improvement: Periodically review the process/identify areas for improvement to achieve market competitiveness. Troubleshooting: Identify the root cause of OOS & provide robust CAPA Address unplanned deviations of the Plant with the Solutions. New Product Development: Develop new products in the stipulated timeline as per cGMP requirements. Alternate vendor development: Undertake alternate vendor development to improve the product quality and reduce raw material cost. Pilot & technology Transfer: Scale up laboratory batches in the Pilot plant & establish feasibility. Ensure that development is implemented by Process & Technology transfer. Ensure the Process is robust, safe & ...

Greetings!!! We are seeking for an API - R & D Synthesis role for a RKS API Pvt. Ltd. at Gurgaon, Haryana. Required Candidate profile An API R&D Synthesis Chemist develops and optimizes processes for API through multi-step organic synthesis, ensuring scalability, purity, and compliance with regulations.

We are Hiring for Manager / Sr. Manager - QA (API Pharma Industry) Designation: Manager / Sr. Manager Division: QA Reporting: Plant Head Qualification: M.Sc (Chemistry) Years of Experience: 15 yo 20 Years CTC range: Current CTC not more than 14 to 20 Laks. Job Locations: Chennai No. of Positions: 1 Preferred candidate profile Handling Team members to ensure Production Assurance, Engineering Assurance, IT, HR & EHS assurance. Handling regulatory audit USFDA/ Customer audits and preparation of Compliance report with HOD and CAPA effectiveness tracking. Preparation & Review of Site Master File, Validation Master plan & Quality Manual. Handling of Vendor selection, Evaluation and Approval. (Vend...

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...