682 Change Control Jobs - Page 11

Role & responsibilities :- Hands on experience for BMR, Process validation report, Stability Protocol, Sampling Plan, Knowledge about GDP initiation and closure of Change control, deviation in GMP. Having good knowledge of guidelines SUPAC, cGMP, Compliance, ICH Q1A,Q2,Q7, Q8,Q9, A10, Q13. Knowledge about GAP assessment between sending unit and receiving unit equipment / instrument / documents. Hands on experience with Advanced Microsoft Word, Power point and excel Effective communication and Co-ordination with CFT. Sound Scale up/down knowledge Calculation, forecasting, Risk assessment etc. Plan Lab scale experiments and perform. Preferred candidate profile :- Must Have Experience in Tech Transfer Department Documentation. M. Pharma in Pharmaceutics Proficiency in MS- Word, Excel, PowerPoint Perks and benefits :- As per Company Standard

Key Responsibilities: Administer and maintain SQL Server databases, ensuring high availability (HA) and optimizing performance. Perform regular database backups, monitoring, and auditing to maintain data integrity and security. Utilize PowerShell scripting to automate routine database tasks, streamline processes, and improve operational efficiency. Perform performance tuning to optimize database systems for improved speed and responsiveness. Monitor and troubleshoot database-related issues, ensuring quick resolution of any operational problems. Implement and maintain disaster recovery procedures to ensure data availability and minimal downtime. Collaborate with other IT teams to ensure databases support application development and deployment. Required Skills: SQL Server Administration (3 to 5 years): Experience in managing SQL Server databases, including high availability (HA), performance tuning, backups, monitoring, and auditing. PowerShell Scripting: Proficiency in using PowerShell to automate tasks and enhance database management processes. Strong troubleshooting and problem-solving skills related to database systems.

Role & responsibilities Responsibility of Downstream activities in bulk manufacturing facility. To ensure that Downstream batches are carried out as per manufacturing instructions following relevant Process Development description document, MFR, SOPs, BPRs, Protocols etc. and to ensure appropriate documentation in order to maintain cGMP compliance. Preferred candidate profile To understand and follow the safety practices and usage of PPEs in Bulk manufacturing facility and during process. Execution of Scale up of Development batches in Bulk manufacturing facility. Tracking of inventory of consumables used in manufacturing. Ensure Facility monitoring, readiness & maintenance of BM facility. Coordination with Engineering department on tracking and completion of preventive maintenance of Downstream Equipments and instruments. Following good documentation practices such as online documentation like BPR, equipment log, record sheets, etc. in Downstream process. Preparation of Batch production records, SOPs, record sheets and related documents for Downstream related activities in Bulk Manufacturing Facility. Review of Batch production records and related documents in Downstream process. Responsible for timely closure of Batch production records (BPRs), Protocols and reports related to the Downstream process. Coordination with Vendors on equipment and instruments qualification related to the Downstream process. Initiation and closure of change controls, deviations related to Bulk Manufacturing area. Ensure the timely revision of BPR, SOP and study protocols related to downstream process. Responsible for LMS activities as a department training coordinator. Involving in internal audits, local DCGI audits and any other regulatory agencies. Involving in training on safety related activities and imparted training to pooled staff.

Sr. Team Member - Compliance: Responsibilities Assist in identification of key risks and conduct risk assessment for such identified areas Review and carry out the impact assessment for various key risks parameters and determine the inherent and residual risks Closely monitor, analyze the risk assessment reports and conduct control testing of various risk controls and assess the effectiveness of such mitigation measures and controls Assist in preparing the compliance risk assessment report and a summary report for the Management Participate in cross functional discussion, assist in required processes change for mitigating the risks, and provide necessary training and assistance. Qualification Graduation in any discipline General knowledge on life insurance and pension Should possess excellent communication, collaboration skills with ability to work in a matrix Experience 4 - 8 years of overall experience

Aster Medcity is looking for Senior Executive to join our dynamic team and embark on a rewarding career journey Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.

Opening for an Pharma Compay. Location : Bhiwadi. Job Description: Hands-on experience in QA documentation Qualification and validation activities QMS (Quality Management System) activities Interested candidates shared resume on snehal@topgear@gmail.com

Key Responsibilities: Administer and maintain SQL Server databases, ensuring high availability (HA) and optimizing performance. Perform regular database backups, monitoring, and auditing to maintain data integrity and security. Utilize PowerShell scripting to automate routine database tasks, streamline processes, and improve operational efficiency. Perform performance tuning to optimize database systems for improved speed and responsiveness. Monitor and troubleshoot database-related issues, ensuring quick resolution of any operational problems. Implement and maintain disaster recovery procedures to ensure data availability and minimal downtime. Collaborate with other IT teams to ensure databases support application development and deployment. Required Skills: SQL Server Administration (3 to 5 years): Experience in managing SQL Server databases, including high availability (HA), performance tuning, backups, monitoring, and auditing. PowerShell Scripting: Proficiency in using PowerShell to automate tasks and enhance database management processes. Strong troubleshooting and problem-solving skills related to database systems.

Roles and Responsibilities: Work experience of Accounts Payable/Procure to Pay Knowledge on GST, IGST, CGST, TDS, VAT Invoice Processing/Invoice audit/vendor payments experience must SAP end user experience in FI Module for Financial accounting is must. Advanced Excel, PPT, MIS report and other analytical reporting knowledge & experience is an added advantage. Knowledge about different kind of payment methods and payment term. PO and non PO invoices handling

Roles and Responsibilities: Work experience of Accounts Payable/Procure to Pay Knowledge on GST, IGST, CGST, TDS, VAT Invoice Processing/Invoice audit/vendor payments experience must SAP end user experience in FI Module for Financial accounting is must. Advanced Excel, PPT, MIS report and other analytical reporting knowledge & experience is an added advantage. Knowledge about different kind of payment methods and payment term. PO and non PO invoices handling Applications from people with disabilities are explicitly welcome.

Work with Us. Change the World. At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world’s most complex challenges and build legacies for future generations. There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world. We're one global team driven by our common purpose to deliver a better world. Join us. Technically supervises quality projects or major phases of significant quality projects, coordinating the efforts of technical support staff in the performance of assigned project. Possesses and applies comprehensive knowledge to the completion of significant quality assignments. Provides leadership for quality assurance and quality control support on assigned program(s) and/or areas to ensure that the project is designed, procured and installed in accordance with customer and company quality requirements. Provides leadership for new systems, development, proposals, implementation, procedures and any related quality activity. Develops and applies advanced quality assurance/control theories, as well as research techniques in the investigation and solution of complex and advanced technical problems on the forefront of new technologies. Analyzes, evaluates and plans methods of approach, as well as organizes means to achieve solution of complex technical problems. Reviews project process and evaluate results. Evaluates vendor capabilities to provide required products or services. Makes frequent decisions using principles and professional independent judgment. Conducts investigations and tests that are of considerable complexity. Provides technical consultation to lower level engineers, technicians and inspectors. Qualifications Engineering Graduate Additional Information

Work with Us. Change the World. At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world’s most complex challenges and build legacies for future generations. There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world. We're one global team driven by our common purpose to deliver a better world. Join us. Technically supervises quality projects or major phases of significant quality projects, coordinating the efforts of technical support staff in the performance of assigned project. Possesses and applies comprehensive knowledge to the completion of significant quality assignments. Provides leadership for quality assurance and quality control support on assigned program(s) and/or areas to ensure that the project is designed, procured and installed in accordance with customer and company quality requirements. Provides leadership for new systems, development, proposals, implementation, procedures and any related quality activity. Develops and applies advanced quality assurance/control theories, as well as research techniques in the investigation and solution of complex and advanced technical problems on the forefront of new technologies. Analyzes, evaluates and plans methods of approach, as well as organizes means to achieve solution of complex technical problems. Reviews project process and evaluate results. Evaluates vendor capabilities to provide required products or services. Makes frequent decisions using principles and professional independent judgment. Conducts investigations and tests that are of considerable complexity. Provides technical consultation to lower level engineers, technicians and inspectors. Qualifications Engineering Graduate Additional Information

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 June 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

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 No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

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 Graduation in Science or Chemistry

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, orders and/or other inquires. 8. Work closely with other departments (including, but not limited to: Production Control, Project Quotations, Application Engineering, Manufacturing Engineering) to resolve issues. 9. Manage and administer Letters of Credit, Commercial Invoice. 10. Proper documentation of all correspondence between vendor, customer, and Crescent throughout the project is critical and must be thoroughly performed. 11. Collect and Analyse quotations data to determine patterns of success or failure. Measure results and performance by product type, manufacturer, bid amounts, and customers. Qualification and Experience : 1. Should be a Graduate. 2. Should have at least 1- 2 years of experience in Quotation and Documentation preferable from a manufacturing company.

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 impurities. Harmonization of Cleaning and validation procedures across all sites of Lupin. Work Experience 10-12 years Education Masters in Science Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility

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 and implement enhancements Develop and maintain documentation related to SAP PM processes and procedures Strong communication and collaboration skills Strong analytical and problem-solving skills

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 of 6-9 years: 1. Comfortable working with any of the three major Linux distros (Redhat, Sles, Ubuntu). Preferably on a Z system (s390x) 2. Knowledge on Web Services, API Testing 3. Understanding of virtualization and containerization concepts. z/VM and KVM are preferred. 4. Experience building pipelines for automation servers such as Jenkins etc 5. Skilled in a scripting language. Python, Ansible or bash is preferred. 6. Quick learner and a strong team player with good communication and interpersonal skills 7. Self Driven and Proven ability to work effectively in a global team environment. 8. Good decision making skills 9. skills on z/OS, CICS,Db2,IMS,MQ,DFSMS VSAM & VSAM ,RLS Preferred technical and professional experience 1. Leading and Guiding Team. 2.Providing direction and support to the team to achieve shared goals. 3. Taking initiative and anticipating needs or challenges before they arise

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 for co-ordination during regulatory inspections and customer audits. Responsible for co-ordination with all stake holders for appropriate action plans for the corrective and preventive actions (CAPA) and timely closure. 7. Review and approval of stability summary report and handling of stability failures. Responsible for timely communication with corporate regulatory department on the stability failures for further actions with regulatory agencies and customers. 8. Responsible for the co-ordination with QC and other agencies for the timely qualification of working reference standards (WRS) of APIs, intermediates and impurities. 9. Responsible for the management of Skip Testing and associated documents. 10. Responsible for ensuring compliance of products against monograph specification. 11. Review and approval of analytical raw data before the regulatory submissions for filing. [B] Validation. 1. Responsible for review and approved of Process Performance Qualification protocols and reports through Documentum system. 2. Responsible for review and approved Cleaning Validation and Verification protocol and report through Documentum system. 3. Ensure compliance of validation master plan. A. Batch release and Dispatch: 1. Responsible for batch release, Certificate of analysis and material dispatch related activities. 2. Responsible to communicate the business development and PPIC in case of any delays in the dispatches due to any reasons. B. QMS: 1. Responsible for Handling of Market complaint, returned goods and Recall activities. C. Product review: 1. To ensure preparation, review & approval of Annual Product Quality Review (APQR) as per scheduled timelines in coordination with other departments. D. Audit and Compliance: 1. Responsible for audit preparation, compliance and response to regulatory and customer. 2. Responsible for Retain sample management of APIs & Saleable Intermediates. 3. Perform internal audits within Alembic site. E. Customer Support/ Compliance: 1. Co-ordinate with Production, QC, supply chain, logistic, purchase and Marketing department for dispatch related activities and customer queries. 2. To support the business development team during the development of new customers by providing required information as part of questionnaire assessment and Technical quality agreement. 3. Coordination with quality control for specification, standard test procedures and QC related queries generated by customers. 4. Handling of CAPA & Change control activities for implementation, monitoring and assessment. 5. Review and approval of documents in DCS/Documentum. 6. Any other task assigned by QA Head.