1120 Change Control Jobs - Page 26

Walk-in at Matoda Were currently recruiting for multiple positions at our SANAND manufacturing facility. If any role aligns with your experience, please bring your updated resume and walk in during the scheduled drive. Please find our current job requirements and venue details mentioned. Requirement : Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI Time and Venue : 12th JULY 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot...

Develop and implement business development strategies. Identify and engage potential clients. Collaborate with internal and external stakeholders. Monitor business development performance and suggest improvements. Prepare reports and documentation. Provide training and support to staff.

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.

Executive-CQA Long Description 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation Work Experience 5 - 8 years

Executive-CQA-VQG 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 3. Customer Centricity 5. Result Orientation Education Masters in Chemistry Post Graduation in Pharmacy 5-8 YearsWork Experience

Work Experience 12 to 15 years of experience in Pharma Vendor Audit Management 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3. To execute vendor Audits, CAPA tracking, and qualification documentation 4. To schedule and monitor the Vendor Audits 5. To work on VQ special projects in coordination with Project IT team 6. To track the project till its implementation and Go Live across all sites Technical , behavioral & managerial 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 5. Result Orientation 3. Customer Centricity Education Masters in Pharmacy Post ...

1. Need to prepare all the relevant documents for any quotations and forward the same to the customer. 2. Need to identify attractive rate for the quotation. 3. Review technical documents provided by the client including, but not limited to, specifications, data sheets, drawings, competitor literature/information. 4. Answer technical questions relating to products from customers, reps, and partners. 5. Aid customers, reps, and partners in the selection of products based on provided specifications/information. 6. Follow-up on Opportunities/Quotes in order to secure business. 7. Professionally communicate with customers, representatives, and other partners to resolve issues relating to quotes,...

Job Description Responsible for Toxicological assessment of genotoxic and nitrosamine impurities. Responsible to support the development of nitrosamine and other genotoxic impurity risk assessment and carryover limits. To support the site management team in reviewing cleaning, nitrosamine and genotoxic impurity and keep sites up to date according to current regulatory requirement /expectation. Reviewing Permissible Daily Intake, Occupational Exposure Limits, Toxicological Justification, Quality Risk Assessment document. Responsible for preparation and revision of corporate procedures like SOP related to the assessment of potential carryover or cross-contamination of genotoxic/carcinogenic im...

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.

Kokan Ngo is looking for Documentation Officer to join our dynamic team and embark on a rewarding career journey Prepare and maintain accurate and detailed documents and records. Ensure compliance with documentation standards and regulations. Collaborate with cross-functional teams on documentation projects. Review and edit documents for accuracy and clarity. Organize and manage document storage and retrieval systems. Provide training and support on documentation practices.

Diverse Lynx is looking for SAP PM Consultant to join our dynamic team and embark on a rewarding career journey Develop and maintain the SAP PM module in accordance with industry best practices Configure and customize SAP PM to meet specific business requirements Create functional specifications for SAP PM enhancements and work with the development team to implement changes Conduct system tests and user acceptance tests to ensure the solution meets business requirements Provide support and training to end-users on SAP PM processes and procedures Collaborate with cross-functional teams to troubleshoot and resolve issues related to SAP PM functionality Identify areas for process improvement an...

As a Solution Tester, you will be responsible for: 1. Designing and automating test suites to ensure reliability of the system z(s390x) platform technology 2. Having a client-first mindset to test at scale and imitate customer-like environments 3. Creating strategies and scripts to test new features and functionalities 4. Contributing and reviewing code for internal and external repositories 5. Documenting processes (Test plans) and procedures for clarity and reproducibility 6. Interacting with counterparts in US/Germany teams and Red Hat Required education Bachelor's Degree Required technical and professional expertise Required Technical and Professional Expertise with relevant experience o...

JOB RESPONSIBILITIES : [A] Regulatory Compliance : 1. To co-ordinate with corporate regulatory department for submission of documents as part of filing of DMF, updating and response to queries to US, Europe, China, Japan, Korea and Rest of World market. 2. To co-ordinate with various department for the timely submission of documents and its compliance. 3. Coordination with quality control, analytical development lab (ADL) and corporate validation Lab (CVL) for specification and standard test procedures. 4. Coordination with CQA for document preparation and implementation. 5. Keep the track of technology/Analytical Method transfer and other documents received from ADL and R&D. 6. Responsible ...

Responsibilities: * Conduct BPR reviews, change control procedures & equipment validation. * Ensure compliance with industry standards through quality assurance processes.

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Semina...

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Semina...

Roles and Responsibilities Ensure compliance with IPQA guidelines and regulations during production processes. Conduct regular inspections of manufacturing areas, equipment, and documentation to identify deviations from SOPs. Implement change controls by reviewing changes, conducting risk assessments, and ensuring effective implementation. Monitor CAPAs (Corrective Action Preventive Actions) to ensure closure within specified timelines. Collaborate with cross-functional teams to resolve quality issues and improve overall process efficiency. Desired Candidate Profile 5-10 years of experience in pharmaceutical quality assurance or related field. Strong understanding of IPQA principles, GMP reg...

Qualification : B.Pharma Experience : 3 to 10 yrs. Designation : Officer Salary Range : 6 to 7 Lacs PA. Unit : Injectable Kindly Find the JD. Management of Aseptic Process Simulation (Media Fill) Program. Review of quality systems such as Change Control, Deviations, CAPA, OOS, OOT, LIR, Market Complaint, FAR, Product Recall and other QAMS documents. Preparation and Review of APQR. Nitrosamine Risk Assessment of Drug Product Preparation and review of site QA SOP and review of cross-functional department SOP. Review of Batch Manufacturing Record and Batch Packing Record. Preparation, review and execution of hold time study of drug product. Preparation and review of thermal cycling and temperat...

bmr review, Bpr review, sop preparation,

Role & responsibilities Job Summary We are seeking an individual for the Quality Control Microbiology team, responsible for review and approval of microbiology analytical data/record, review of EM and water trend, monitoring of aseptic process simulation. Review and approval of Analytical method validation related to Microbiological test. This role includes the participation into investigation related to Microbiology Roles & Responsibilities Responsible for Review and release of Microbiological Tests (Environmental Monitoring, Water Testing, Microbial Limit Test, Sterility Test and Bacterial Endotoxins Test). Responsible for review and Approval of Microbiological testing data/ Master data in...

NAB is looking for Analyst to join our dynamic team and embark on a rewarding career journeyGather, analyze, and interpret complex datasets to identify trends, patterns, and insights that support strategic decision-making within the organization.Develop, maintain, and update detailed reports, dashboards, and visualizations to communicate key metrics and findings to stakeholders.Collaborate with cross-functional teams to understand business needs, translating them into data requirements and actionable insights.Conduct market research, competitor analysis, and customer behavior studies to inform business strategies and improve performance.Monitor data integrity and accuracy, implementing quali...

Job Overview To ensure effective quality assurance activities related to batch release, review of analytical data, batch records, QMS elements, and compliance with regulatory standards to support timely product release. Roles & Responsibilities: Batch Release Management Hands on analytical experience Review of QC Analytical Data including electronic data review Review of Batch Records including audit trail review Preparation and Review of APR Responsible for review of QC activities Initiation and review of QMS elements (Deviation/Change Control/OOS/OOT/CAPA) Dispatch and Line clearance Cleaning Validation Competencies Quick learner with excellent communication skills Punctual with proven tra...

Job Responsibilities: 1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.). 2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc., 3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc., 4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. 5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. 6. Preparation/Revision of CQA SOPs and making master, effective after completion ...

Job Summary We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards. " Roles & Responsibilities You will be responsible for executing or assigning in-process activities during shifts, conducting line clearances, material verification, overseeing start-up of machines, and coordinating sampling activities to ensure product quality and compliance. You will be re...

Job Summary We are looking for an individual for the SIT Team to oversee the investigation of major and critical deviations, working closely with Cross-Functional Team (CFT) members to identify root causes and implement corrective and preventive actions. The role involves active participation in investigating Out of Specification (OOS) cases, ensuring accurate classification in the DCMS deviations log, and providing support during regulatory inspections. Roles & Responsibilities • You will be responsible for overseeing the investigation of major and critical deviations from the outset, collaborating closely with Cross-Functional Team (CFT) members to identify root causes, corrective actions ...