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4.0 - 9.0 years
3 - 8 Lacs
Noida
Work from Office
Role & responsibilities Having experience in Pharma Plants certified by Regulatory bodies like USFDA, MHRA, EU-GMP, WHO-Geneva, etc. Candidate should have expertise in following : * Hands on experience in risk based qualification approach of pharma equipments (OSD / Sterile/ API) and clean utilities (HVAC system, WFI, PW, PSG, Compressed air, Nitrogen system etc. cleaning and process validation, * Conversant with RA, VMP, DQ, IQ, OQ, PQ document preparation and practical experience of protocol execution. * Quality Management System emeil id : hr@cgmppharmanplans.com Mobile +91 9650698486 Preferred candidate profile Perks and benefits
Posted 1 week ago
5.0 - 10.0 years
18 - 33 Lacs
Hyderabad, Chennai, Bengaluru
Hybrid
Role & responsibilities Developer/ Lead 5+ years Responsible for leading CDQ/IDMC development and delivery - Responsible for analysis, development and deploy DQ rules using CDQ. Preferred candidate profile
Posted 2 weeks ago
7.0 - 10.0 years
12 - 15 Lacs
Pune, Bengaluru
Hybrid
DQ,DL,DM, Data Analysis, Data Mapping , Collibra Introduction: As a Data Lineage Analyst, you will play a crucial role in enhancing the transparency and understanding of data flow within our organization. This position is ideal for someone who is passionate about data management, data quality, and governance and seeks to leverage these skills to drive meaningful insights that influence strategic decisions. Key Responsibilities: Analyze and Document Data Lineage: Track data elements from their origin through various transformations to their final form, documenting the data flow and any processes that impact data. Improve Data Quality: Identify areas where data quality can be improved and collaborate with data governance and IT teams to implement enhancements. Collaborate on Data Management Policies: Work with data governance teams to develop guidelines and policies that ensure data accuracy and consistency across the organization. Stakeholder Engagement: Regularly engage with business and technical stakeholders to gather requirements and provide updates on data lineage projects. Tool Implementation: Utilize and help to implement tools and technologies designed to automate and facilitate data lineage tracking and reporting. Data Mapping and Metadata Management: Create and maintain mappings of data sources, transformations, and consumers, along with metadata to support data lineage. Troubleshoot Data Issues: Identify and resolve issues related to data flow and lineage in collaboration with data engineering teams. Qualifications: Bachelors degree in information technology, Computer Science, Data Science, or a related field. Proven experience in a data-focused role, preferably with specific experience in data lineage, data analysis, or data governance.
Posted 2 weeks ago
2 - 4 years
0 - 1 Lacs
Navi Mumbai
Work from Office
Qualification : Bachelor's degree in a related field or equivalent work experience. Years of experience : 1 to 4 Years relevant experience Required skills : Proven experience in technical document control or a related field. Strong knowledge of document management software and tools. Attention to detail and the ability to work with complex technical documents. Familiarity with project management Familiarity with industry standards and regulations related to documentation. Roles & Responsibilities Manage and control all technical documents, including engineering drawings, manuals, specifications, and procedures Ensure that all technical documentation adheres to regulatory and quality standards. Facilitate the retrieval of technical documentation Collaborate with subject matter experts to review and validate technical documents Ensure that all technical documentation adheres to regulatory and quality standards.
Posted 1 month ago
2 - 7 years
1 - 4 Lacs
Bharuch, Ankleshwar, Karjan
Work from Office
To get GA drawing approval from client in consultation with V TOP& Marketing Execute DQ. Documentation of project,tracking &reporting of project status report Update Brahma& reports, collect all reports like kick off Updating Drawing approval report Required Candidate profile Co-coordinating with factory & marketing team Co-ordination of activities between design, planning, material production and vendor management Keeping track of short supplies Updating PLC FDS
Posted 1 month ago
- 5 years
4 - 8 Lacs
Visakhapatnam, Hyderabad/Secunderabad
Work from Office
Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.
Posted 1 month ago
8 - 13 years
5 - 9 Lacs
Aurangabad
Work from Office
Academic: 1. Should have minimum qualification of M.Sc preferably in chemistry. 2. Minimum 10+ years experience 3. Academic career should be good (preferably first class and above) 4. Candidate will be preferred having good communication skill and writing Job Profile: Equipment Qualification protocol / report review DQ, IQ, OQ, PQ, FAT & SAT Should have knowledge of API process equipment like reactor, centrifuge etc. Equipment URS review, Layout, P & ID review Handling of QMS documents Like Change control, Deviations, Incidences, Performing the Investigation using different investigation tools. Performing the Risk Assessment like nitrosamine Risk Assessment, Quality risk Assessment. HVAC Qualification, PP area Qualification. Handling of temperature mapping activities. Facility Qualification
Posted 2 months ago
4 - 9 years
0 - 3 Lacs
Aurangabad
Work from Office
1) To prepare the Standard operating procedure for Engineering Department. 2) Operation & Maintenance of Purified Water System, UF, CSRO, HSRO, EDI & Distribution loop system 3) Operation & Maintenance of HVAC/AHU system in API Industry, Pressure balancing, Filter cleaning & area validation activity at site. 4) To prepare qualification documents DQ/IQ/OQ for the equipment to be install at site. 5) To prepare preventive maintenance schedule for the newly installed equipment. 6) To comply the Engineering related points as per cGMP & GDP practices. 7) To Orient the Engineering Team towards Updated Knowledge for cGMP and Regulatory Norms. 8) To maintain discipline with co-employees & workers. 9) To initiate & implementation ideas with respect to energy conservation. 10) To allocate manpower as per work priority. 11) To ensure the critical equipment spares as availability and Co Ordinate with engineering store. 12) To maintain engineering related documents. 13) To act as training coordinator.
Posted 2 months ago
3 - 8 years
4 - 5 Lacs
Hyderabad
Work from Office
Designation: Quality Assurance Chemist Location :Medchal, Hyderabad Qualification: B.sc/B.pharma Experience: Min.3 relevant exp as Qa chemist Package: 4-5LPA Shifts: General shifts If interested Contact: 8247381453 Share Cv laxmi@hireiton.com Required Candidate profile • Qualification of utilities like Purified Water systems • Reviewing BMR/BPR & issuing analytical worksheets, logbooks • Must have worked in a pharmaceutical company in the past
Posted 2 months ago
4 - 9 years
0 - 3 Lacs
Aurangabad
Work from Office
1) To prepare the Standard operating procedure for Engineering Department. 2) Operation & Maintenance of Purified Water System, UF, CSRO, HSRO, EDI & Distribution loop system 3) Operation & Maintenance of HVAC/AHU system in API Industry, Pressure balancing, Filter cleaning & area validation activity at site. 4) To prepare qualification documents DQ/IQ/OQ for the equipment to be install at site. 5) To prepare preventive maintenance schedule for the newly installed equipment. 6) To comply the Engineering related points as per cGMP & GDP practices. 7) To Orient the Engineering Team towards Updated Knowledge for cGMP and Regulatory Norms. 8) To maintain discipline with co-employees & workers. 9) To initiate & implementation ideas with respect to energy conservation. 10) To allocate manpower as per work priority. 11) To ensure the critical equipment spares as availability and Co Ordinate with engineering store. 12) To maintain engineering related documents. 13) To act as training coordinator.
Posted 2 months ago
1 - 3 years
1 - 3 Lacs
Hyderabad
Work from Office
all drawings related to Change controls Modifications Responsible for all Auto cad Preparation of P&ID layout as per URS BOQ as per P&ID URS DQ IQ OQ and PQ Utility equipment's HVAC PR creation and bills service entry PR PO tracking, GRN tracking
Posted 2 months ago
2 - 5 years
5 - 10 Lacs
Hyderabad
Work from Office
Documentation Management: Lead the creation, review, and approval of qualification documents (DQ, IQ, OQ, PQ). Revision Control: Maintain effective revision control to ensure all documents are current and compliant. Quality Assurance: Collaborate with QA teams to meet regulatory and quality standards. Training and Support: Provide training on documentation practices and regulatory compliance. Cross-Functional Collaboration: Work with engineering and validation teams for comprehensive documentation. Audit Readiness: Ensure documentation is complete and accessible for audits. Process Improvement: Identify and implement best practices to enhance documentation workflows. Regulatory Compliance: Stay updated on industry regulations and align documentation practices accordingly. Risk Management: Assess documentation-related risks and implement corrective actions. Reporting: Generate reports on documentation status and compliance metrics for senior management.
Posted 3 months ago
3 - 7 years
2 - 4 Lacs
Vadodara, Savli
Work from Office
Responsibilities: Will be responsible for handling HVAC, water treatment plant, compressed air, handling of boiler / chiller / air compressor & ETP and pharmaceutical machinery, repairs and maintenance. Will be responsible for AMC and preventive maintainance Schedule and will be responsible for plant maintenance. The candidate must have knowledge of BMS systems, handling PLCs and also have knowledge of DQ, IQ, OQ and PQ. Keeping equipment operational by coordinating maintenance and repair services, following manufacturer's instructions and established procedures, requesting special services will all be part of the job responsibilities Will be involved in handling all pharmaceutical machinery. Will be responsible for confirming system and product capabilities by designing feasibility and testing methods, testing finished product and system capabilities; confirming fabrication, assembly, and installation processes. Responsible for keeping equipment operational by coordinating maintenance and repair services; Maintain product and company reputation by complying with government regulations Develop processes by designing and modifying equipment as per the requirement and making sure the project is completed by training and guiding technicians. Prepare reports by collecting, analyzing, and summarizing information and trends. Provide engineering information by answering questions and requests. Maintain system and process data base by writing computer programs and entering data. Experience with computer software, AutoCAD, Microsoft Word, Powerpoint & Excel Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies. Needs to be self-motivated, cooperative, work well with others Ability to trust Team members and support Team Decisions Roadmap would be heading the engineering department. Should be able to contribute to team effort by accomplishing related results as needed. Should have managed a team/teams.
Posted 3 months ago
5 - 7 years
7 - 10 Lacs
Dahej
Work from Office
Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Client: Subsidiary of the American MNC Pharma Company Position: Assistant Manager - QA (Green Field Project) Location: Dahej, Gujarat Job Profile: Projects Cycle management for Validation & Qualification of Green Field Projects. Document Preparation of all phases of Validation of major from scratch. Conducting QA validation lifecycle documentations. Preparing & reviewing of documentations related to URS, DQ, IQ, OQ & PQ Preparation & Reviews of documents related to Validation Master Plan & Project Validation Plant, Validation Protocol & Reports, and Qualification related documents. Assist in the monitoring and periodic revalidation of equipment and processes. Follow all regulatory guidelines & cGMP guidelines, as required by the job function. Liaise with key personnel within project teams to ensure validation tasks are completed in a timely manner Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility. Desired Profile: Graduate Engineer in any Discipline with 5 to 7 years experience in QA documentations especially in Green Field Projects. Preferably worked in Pharma with experience in Documentation related to URS, DQ, IQ, OQ & PQ. Exposure to Green field Projects would be first preference. Expertise in preparing documentations related to green field projects with Parma. Extremely meticulous, methodical & process oriented Stay informed about advancements in QA, regulatory requirements, & industry trends. Continuously expanding knowledge & skills to enhance performance and contribute to continuous improvement initiatives. Recruiter Profile: BEST - FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India E-Mail: hrd@bfrr.in Website: www.bestfitrecruitment.co.in
Posted 3 months ago
5 - 10 years
1 - 6 Lacs
Vadodara, Halol
Work from Office
To prepare and review Validation Master Plan (QMP, VMP, PVMP, CVMP and CSVMP). To follow the validation master plan.To prepare and review qualification and validation documents and execution as per protocol. Required Candidate profile Preparation&review of URS,FS,DS,DQ,RA,IQ, OQ&PQ & summary reports for Equipment, System&Utilities.Handling & storage of all quality document like BMR,BPR,log book, protocol & SOP throughout life cycle
Posted 3 months ago
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