876 Process Validation Jobs

Urgent opening for QA Officer/sr.Officer - API in Dahej location Position : Quality Assurance (API Plant) Exp.: 4 to 8 years in Same profile Experience in API plant Analytical Compliance,Cleaning Sampling,Process Validation,QMS,Qualification

Job Description JOB Responsibilities: - Location: Ahmedabad 1. Ensuring the GMP compliance at CMO and Release of batch manufactured for US market at CMU. 2. Monitoring of process starting from dispensing to packing including witness analysis of Lupin products manufactured at CMO for US market and Domestic market. 3. Handling of market complaint with root cause identification and ensuring the CAPA implementation. 4. New product review to be carried out at manufacturing site after availability of all the documents. 5. Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished p...

0 Responsibilities: To carry out the following routine checks in the laboratory on daily basis: Responsibility for investigation report writing and closure of deviation, OOS and OOT. Qualification of working standards. Glassware verification & labelling. Routine calibration and verification of all instruments. Logbooks verification. To ensure that the documentation done is online and error free. To ensure the correctness of the document before submitting it for the review of Group Leader/AQA reviewer. Column stock, inventory, indent, requirement and routine usage verification. Reference/Working standard and impurities verification. Area upkeep and maintenance. Calibration schedule/document/l...

Preferred candidate profile Diploma in pharmacy/mechanical/electrical with minimum 1 year experience in OSD production. Recruiter Mohaneswara https://www.linkedin.com/in/mohaneswarareddy Role & responsibilities Operate Fluid Bed Equipment and Spheroniser as per SOP, including cleaning and line clearance activities to ensure readiness for production. Strict adherence to safety, health and environment. Carry out Manufacturing activities by following and monitoring standard operating procedure (SOP) and current Good Manufacturing Practice (cGMP). To ensure effective implementation of RFT and Data integrity policy. Maintenance, upkeep of the department, premises, and equipment. To maintain disci...

1-Understanding of regulatory requirements 2-Must Have Knowledge in regulation of Class I, II and III medical devices 3-Exp in regulatory affairs within the medical device industry. Interested candidate can directly apply on recruit@shalya.in

Coordinate with production teams to resolve quality issues in real time, Ensure compliance with GMP, ISO, or other applicable quality standards Verify raw materials, semi-finished, and finished products as per quality parameters.

About Us Established in the year 2000 in the US, we have global offices in the US, India, UK, Australia, Mexico, Vietnam, and Canada, with best-in-class infrastructure and development facilities spread across the globe. We are an end-to-end solution provider in Banking & Financial Services, Telecom, Healthcare, Manufacturing & Energy verticals and have successfully delivered $1 billion worth of projects for more than 20 Fortune 500 companies. Position Name Documentum Lead Experience 10 - 13 yrs Location Bangalore Shift Timings Custom Job Description Key Responsibilities: Act as the technical expert for Documentum workflows, configurations, and integrations. Lead and oversee quality assurance...

Purpose The Supplier Quality Engineer will be responsible for end-to-end supplier quality activities, including APQP execution, process validation (IQ/OQ/PQ/TMV), PV testing, data analysis, and support for manufacturing line design (MLD) changes. The role ensures supplier compliance with Quality Management System (QMS), medical device regulations, and global quality standards. Key Responsibilities APQP & Supplier Readiness Execute APQP activities including Specification Review, Product Quality Planning (PQP), PFMEA, Process Flow Diagrams, and Control Plans. Drive PSW closure and support First Article Inspection (FAI) reviews. Coach and support suppliers on APQP, validation readiness, and Goo...

Job Description Primary Job Function: u2022Monitoring of assigned TPM sites as per SOP. u2022Ensure product Compliance & Regulatory compliance of Abbott products at TPM sites. u2022Review of sites compliance through periodic visits, prepare the report and ensure the compliance. u2022Review and approval of TPM sites QMS elements (Change controls, incidents, Deviations, OOS, etc..) related to Abbott products and monitoring of action plan for effective closure at sites u2022Ensuring the Compliance for pharmacopeia updates for Abbott products at TPM sites. u2022Investigation of market complaints, significant quality events & review along with site team for RCA, CAPA and effectiveness of CAPA alo...

JOB DESCRIPTION: Primary Job Function: .Monitoring of assigned TPM sites as per SOP. .Ensure product Compliance & Regulatory compliance of Abbott products at TPM sites. .Review of sites compliance through periodic visits, prepare the report and ensure the compliance. .Review and approval of TPM sites QMS elements (Change controls, incidents, Deviations, OOS, etc..) related to Abbott products and monitoring of action plan for effective closure at sites .Ensuring the Compliance for pharmacopeia updates for Abbott products at TPM sites. .Investigation of market complaints, significant quality events & review along with site team for RCA, CAPA and effectiveness of CAPA along with closure of same...

Company Overview Nikkiso Clean Energy & Industrial Gases is a leading provider of cryogenic pumps, heat exchangers, process systems, turboexpanders, services, and solutions for the liquefied natural gas (LNG), liquefied hydrogen (LH2), and industrial gases industries. Applications include fueling stations, marine engines, peak shaving, power generation, virtual pipelines, carbon capture, geothermal power and well stimulation. We are a subsidiary of Nikkiso Company Ltd, a leading industrial manufacturer headquartered in Tokyo, Japan, with $1.5 B USD in annual revenue, 8000 + employees worldwide, and publicly traded on the Tokyo Stock Exchange. Job Overview Responsible for end-to-end developme...

Experience Required: 4+ years Industry: Medical Devices Location: Coimbatore, India Role Summary This dual-role position combines Quality Engineering and Clinical Evaluation responsibilities to ensure that medical devices meet stringent global standards for safety, quality, and regulatory compliance. The ideal candidate will support quality systems, validation processes, risk management, supplier quality activities, and clinical evidence generation. They will also perform clinical literature reviews, analyze clinical data, and contribute to Clinical Evaluation Reports (CERs) aligned with international medical device regulations. Key Responsibilities Quality Engineering Implement and maintain...

Job Overview TE Connectivity's Quality Control and Reliability Teams ensure product and / or product components comply with specifications and quality standards. They test and inspect products against performance and integrity criteria to ensure product quality and reliability, and to determine the suitability of product release. Responsibilities Understand Customer drawings, Technical requirements, Quality requirements, CSR and cascade the requirements to CFT Exposure to Design and process validation testing and understanding test specifications AQE engineers are part of the project core team and being the Voice of the customer as well as the interface to other internal departments Hands on...

As a Manager at Sun Pharma Laboratories Ltd in Guwahati, in the Regulatory Affairs department, your role involves the following responsibilities: - Facilitating 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 with the Quality Management System. - Attending Site Training Program as per site training program and Global Quality Standards requirements. - Submitting Dossier documents after reviewing them against requests received from Corporate regulatory affairs. - Responding to queries on submitted ...

Engineer / Senior Engineer (On-Site) ENNOVI Mobility Solutions India Pvt Ltd 89A, Hosur Road | Electronics City | Bangalore | INDIA 560100 About Company At Ennovi we harness the power of two megatrends - electrification and AI - to help industries innovate at speed, operate smarter, and achieve sustainable growth. By combining these transformative forces with our global reach and best talent, we empower our customers to lead their markets and drive sustainable progress. From automotive to aerospace, consumer electronics, data storage, industrial, and medical markets, we help our customers achieve these megatrends by creating smarter, safer, and more sustainable solutions. We excel in develop...

Expedia Group brands power global travel for everyone, everywhere. We design cutting-edge tech to make travel smoother and more memorable, and we create groundbreaking solutions for our partners. Our diverse, vibrant, and welcoming community is essential in driving our success. Why Join Us To shape the future of travel, people must come first. Guided by our Values and Leadership Agreements, we foster an open culture where everyone belongs, differences are celebrated and know that when one of us wins, we all win. We provide a full benefits package, including exciting travel perks, generous time-off, parental leave, a flexible work model (with some pretty cool offices), and career development ...

equipment utility qualification process validation. cleaning validation. periodic qualification. Continued process validation. Annual Product review. Validation Master Plan. Packing Validation. Computer System Validation/ PLC validation

Responsibilities: Maintain QMS. Calibration Process & cleaning validation Conduct & document annual training Pest Control Review BMR & BPR APQR Change Control CAPA Deviation Eqp. Qualification Perform other quality tasks as instructed by Manager Office cab/shuttle Annual bonus Provident fund Job/soft skill training Travel allowance House rent allowance

Responsibilities: 1. Conduct Product functionality analysis based on product requirements of embedded and electromechanical systems. 2. Executes, performs, summarizes, reports out verification & validation test activities of component / Sub-system / module. 3. Responsible for independently Verifying and Validating the device with minimal / no supervision 4. Good Team player and willing to take more proactive approach since beginning of brainstorming till execution. 5. Develop test methods and fixtures for all development testing including verification while collaborating with development teams or outside resources 6. Document Test Plans, Test Procedures based on functional and usability requ...

Job Description Responsible for review of URS, DQ and vendor/ suppliers documents related to qualification. Responsible for preparation and review of Validation/ Qualification protocol and report. Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities Responsible for preparation and review of media fill and hold time protocol and report. Responsible for preparation of Standard Operating Procedures of Quality Assurance ...

Company Description Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait . We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceut...

Key responsibilities: Executes online Batch Packing Records, online in process as per the parameters mentioned in the BPR, logbook, documents and other formats. take line clearance of area / machine as per respective SOPs. maintain / fill all area / machine related documents like Sequential, area cleaning, daily cleaning log books and other formats of machine & area as per SOP. verify and receiving of dispensed packing material. indent / receive / handle / verification / uses & destruction of stereo as per respective SOP. verify the Leak test of blister / strip as per frequency. If result not satisfactory, rectify the problems. maintain, handle / storage / labelling of machine spares /change...

Work Location - Baddi, Baroda & Navsari Ensure GMP/GLP compliance at Contract Manufacturing sites and third party sites and provide registration documents and required support for registration from site. Ensure availability of current valid master documents like raw material /packing material /finished product specifications batch manufacturing record /batch packing record at site and retrieval of obsolete documents. To check and find non compliances at Contract Manufacturing /Third Party location and ensure corrective and preventive action. To execute, ensure and monitor process validation / Technology Transfer activities, Unit Operation, QMS Compliance at site and arrange for the reports. ...

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

As a Production Process Engineer with 3 to 6 years of experience in pharmaceutical manufacturing, your role will involve optimizing production processes, troubleshooting technical issues, and ensuring adherence to cGMP standards. Key Responsibilities: - Improve and monitor manufacturing processes to enhance productivity, efficiency, and product consistency while minimizing waste and downtime. - Investigate and resolve production issues such as deviations, yield variations, and equipment malfunctions to ensure smooth operations. - Support the preparation and execution of process validation protocols (IQ/OQ/PQ) and ensure timely documentation in line with cGMP and regulatory standards. - Ensur...