Get alerts for new jobs matching your selected skills, preferred locations, and experience range. Manage Job Alerts
6.0 - 10.0 years
7 - 12 Lacs
Gajraula
Work from Office
Role & responsibilities Skills : Candidates should have thorough exposure and proficient knowledge in the following areas at a minimum: Cleaning validations Process validations and continuous process verification Investigations of Out-of-Specifications (OOS)/deviations Review of all documentation (i.e. batch records, test results, deviation, LIR, OOS, CAPA, validation, COA, Change Controls, etc.) prior to disposition (release or rejection) of batch. Review of executed document like batch record etc. and also to ensure on time compliance of errors/deviations identified (if any). Review of step-by-step performance and compliance to batch manufacturing and packaging record requirements and resolution of any errors/deviations identified. Monitoring and follow-up of corrective and preventive actions (review, approval, and on time closure of the CAPA) in order to resolve an event. Review Process/documentation (i.e. Protocol/report) of reviewing effectiveness to determine the effectiveness of a corrective or preventive action. Involving in investigation and ensuring on time closure of the investigation and event with resolution including corrective and preventive actions along with effectiveness determination. Initiating NTM to Senior Quality Unit Management, Operations, and other applicable functions for the purpose of expedited communication of critical quality/compliance related issues. Ensuring Quality interface with internal and external customers when dealing with activities such as issue resolution, product information, or for movement of materials, products, or process from site to site. Developing Process for observing, reviewing, and auditing operations activities in order to facilitate batch review and to assure compliance. Also, ensure self-availability on shop floor as per requirement i.e. support to investigation etc. Responsible for assuring / coordinating for timely shipment, delivery, and/or receipt to assure compliance with regulatory requirements. In addition, responsible to assure appropriate shipping instructions, coordinate/approve route validation and investigation of temperature excursions as required for materials, components, drug substance, and drug product. Responsible for oversight and review of R&D product development & product tech transfer at the site and batch manufacture in GMP areas including resolution of deviations. Provide and ensuring support to Regulatory Affairs for Market Authorization (MA) application and maintenance. Responsible for Collection, compilation, analysis, and review of all data (i.e. manufacturing, packaging, testing, sourcing, deviations, stability, and changes etc.) and information supporting to validation status of a products. Responsible for Review of all documentation associated with the validation of the procedure(s) used to clean the equipment train for a products manufacturing and packaging process and cleaning verifications. This includes cleaning to remove active ingredients and cleaning agents. Responsible for Review of all documentation including protocols and reports associated with the validation of a products manufacturing (and packaging process, if required) and continuous process verification (CPV). Assessment of stability requirements based on the type of validation. Additional responsibilities assigned by the Manger QA (Quality Assurance) / Site quality head.
Posted 2 months ago
10 - 17 years
10 - 20 Lacs
Ahmedabad
Work from Office
We are hiring for a Green Field Projects at Amneal , Ahmedabad. Following is the JD : Key Responsibilities : Lead QA operations related to Qualification & Validation, including Cleaning Validation, Process Performance Qualification (PPQ), and Computer System Validation (CSV). Develop and implement Validation Master Plans (VMP), Contamination Control Strategies, and Quality Risk Management (QRM) frameworks. Ensure qualification and validation of manufacturing equipment, utilities, and computerized systems to meet regulatory requirements. Drive regulatory inspection readiness, acting as SME for audits including USFDA, EMA, ANVISA, and WHO. Implement and optimize QMS using a risk-based approach, ensuring continuous monitoring and integration of compliance standards. Oversee execution of large-scale validation projects, such as Green Field Injectable facilities, and ensure regulatory approval readiness. Collaborate cross-functionally with Quality, Engineering, Production, and Regulatory Affairs teams for the successful and timely delivery of validation-related initiatives. Promote lean validation practices and continuous improvement strategies to enhance operational efficiency and regulatory compliance. Mentor, develop, and manage a high-performing QA validation team in a cross-cultural, fast-paced environment. Key Requirements : Education : Bachelors or Masters degree in Pharmacy, Chemistry, or related life sciences field. Experience : Minimum 15 years of experience in QA with strong specialization in Qualification & Validation within pharmaceutical manufacturing. Proven experience in injectable/sterile manufacturing environments is highly desirable. Hands-on experience in handling international regulatory audits and validations across FDA, EMA, and ANVISA-regulated markets. Technical Skills : Expertise in Cleaning Validation, PPQ, CSV, QRM, and VMP development. Strong command of GxP and global regulatory guidelines. Proficient in developing and managing QMS with focus on compliance and risk management. Leadership Skills : Demonstrated ability to lead cross-functional teams, influence stakeholders, and manage complex projects under tight timelines. Strong communication, decision-making, and coaching capabilities. Preferred Attributes : Green Field project experience, especially in injectables. Recognized as an SME in QA Validation. Familiarity with modern digital QA tools or systems is an added advantage. Interested candidate can share CV at bhuvneshwari.rathore@amneal.com
Posted 2 months ago
3 - 5 years
2 - 5 Lacs
Chennai
Work from Office
business development - Warehouse PPC/BD-W/1312211 Contract Logistics PPL Head Office Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 3 - 5 years ShareApply Basic Section No. Of Openings 1 Designation Grade Assistant Manager - M3 Freshers/Experience Experience Employee Bonus One Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Logistics Private Limited Department Contract Logistics Country India State Tamil Nadu Region Chennai Branch PPL Head Office Skills Skill Sales & Marketing Skills Communication skills Customer Data Minimum Qualification Under Graduate CERTIFICATION No data available Working Language English Hindi Tamil About The Role Person should have experience in business development warehousing business and strong customer data base. person able to convert existing customers on a faced manner. Product knowledge and communication skills are essential capable enough to achieve the targets as per the time frame -from the date of joining within three JC business conversion should take place. .
Posted 2 months ago
1 - 2 years
7 - 10 Lacs
Hyderabad
Work from Office
Apply now » .buttontext67bbcd0b84b126cf a{ border1px solid transparent; } .buttontext67bbcd0b84b126cf a:focus{ border1px dashed #00a3e0 !important; outlinenone !important; } Currently at TechnipFMC? Apply here. Intern/Apprentice Subsea/Surface Engineering Location: Hyderabad, IN #job-location.job-location-inline {displayinline;} Employment type: Employee Place of work: Office Offshore/Onshore: Onshore .buttontext3b34abe12d83182e a{ border1px solid transparent; } .buttontext3b34abe12d83182e a:focus{ border1px dashed #5B94FF !important; outlinenone !important; } .buttontexta77353c8ab1a0824 a{ border1px solid transparent; } .buttontexta77353c8ab1a0824 a:focus{ border1px dashed #5B94FF !important; outlinenone !important; } TechnipFMC is committed to driving real change in the energy industry. Our ambition is to build a sustainable future through relentless innovation and global collaboration – and we want you to be part of it. You’ll be joining a culture that values curiosity, expertise, and ideas as well as diversity, inclusion, and authenticity. Bring your unique energy to our team of more than 20,000 people worldwide, and discover a rewarding, fulfilling, and varied career that you can take in anywhere you want to go. Job Purpose About The Role You are meant for this job if: Skills .buttontextb2a1d6d26c880f7c a{ border1px solid transparent; } .buttontextb2a1d6d26c880f7c a:focus{ border1px dashed #5B94FF !important; outlinenone !important; } Being a global leader in the energy industry requires an inclusive and diverse environment. TechnipFMC promotes diversity, equity, and inclusion by ensuring equal opportunities to all ages, races, ethnicities, religions, sexual orientations, gender expressions, disabilities, or all other pluralities. We celebrate who you are and what you bring. Every voice matters and we encourage you to add to our culture. TechnipFMC respects the rights and dignity of those it works with and promotes adherence to internationally recognized human rights principles for those in its value chain. Learnmore about TechnipFMCand find other open positions by visiting ourCareer Page. Follow us onLinkedInfor company updates. Date posted: Apr 29, 2025 Requisition number: 12941 Apply now »
Posted 2 months ago
2 - 5 years
0 - 3 Lacs
Gandhinagar
Work from Office
About: Sahajanand Medical Division Medical division is approved by state and central licensing authorities and it delivers efficient performance to meet specific requirements. The SLTL brand stents embody that bold spirit, offering a unique blend of our leading-edge technologies and time-tested engineering With Technical Collaboration & Patent Design, the company started indigenous manufacturing of Coronary products, in 2009. The company has a dedicated in-house R&D department approved by DSIR (Department of Scientific and Industrial Research). We believe that every product we make should stand for something. Something more than expected. And thats why we dont manufacture products for stereotypes. We build them for you. Kindly go through our websites mentioned below for further details. Website: www.sltlmedical.com Roles & Responsibility: Handling QA - QMS activities Change Control Deviation Non-conformity documents Line clearance activities Document Issuance Work as an Internal Auditor Skill/Knowledge Required: Graduate / Post Graduate in Science, Pharma, Biomedical 2-5 Years work experience in Quality Assurance role. Preferred from Medical Device industry / Pharma Industry Interested one can share resume on placement@sltl.com/ or What's app at - 9099923320
Posted 2 months ago
Upload Resume
Drag or click to upload
Your data is secure with us, protected by advanced encryption.
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.
Accenture
39581 Jobs | Dublin
Wipro
19070 Jobs | Bengaluru
Accenture in India
14409 Jobs | Dublin 2
EY
14248 Jobs | London
Uplers
10536 Jobs | Ahmedabad
Amazon
10262 Jobs | Seattle,WA
IBM
9120 Jobs | Armonk
Oracle
8925 Jobs | Redwood City
Capgemini
7500 Jobs | Paris,France
Virtusa
7132 Jobs | Southborough