1740 Change Control Jobs - Page 10

Issuance of Analytical Data Sheets and Formats. Preparation and Review of specification and standard test procedure. Review of QC Analytical Data. To ensure online documentation in laboratory as Good Documentation Practices. To attend training as per refresher training schedule. To ensure all time audit readiness in the work area. To perform any other work as and when assigned by Head of department.

Development of Food / Nutritional Products. Review of Literature and Patent, planning and review of protocol and reports of pre-formulation study , review of evaluation reports of innovator/market sample and packaging material. Planning and execution of trial batches and optimization Batches. Responsible for review of documents such as master formula card, technical directions, technology transfer, product specifications, stability protocols and reports. Experienced in handling spray dryer, vibro sifter, and ribbon blender.

1. To prepare annual equipment qualification planner with respect to validationmaster plan. 2. To prepare HVAC / compressed air / effectiveness of cleaning validation planner. 3. Preparation of protocols for qualifications of newly procured equipments and ofequipments transferred from other location. 4. Preparation of protocols for re-qualifications of HVAC system. 5. Preparation and execution of re-qualification protocols and reports as per schedule ofvalidation master plan and as on when required. 6. Toperform cleaning validation cleaning verification. 7. Preparationreview of cleaning assessment report. 8. Preparation review of process validation protocols and reports. 9. Preparation revie...

1. Line clearance in dispensing, manufacturing and packing area 2. In -Process Quality Assurance activities, sampling, analysis and AQL during production. 3. To ensure stage wise completeness of BMR during production. 4. Monitoring of environmental conditions in production area. 5. Coordination with other departments for smooth running of the plant. 6. Calibration, verification and maintenance of IPQA instruments. 7. To monitor process as per technical directions. 8. To fill all IPQA sampling logs in time. 9. To ensure deviations are properly documented and CAPA implemented. 10. To withdraw samples at different stages of In-Process and finished product as well as validation samples as per TD...

Manage day-to-day office operations, including administrative tasks and employee coordination. Handle communications, both internal and external, ensuring timely responses and follow-ups. Organize meetings, prepare agendas, and take minutes for effective documentation. Maintain office supplies and ensure all equipment is in working order. Assist with budgeting, invoicing, and other financial tasks as needed.

As an Officer to Executive in the Production QMS Department at our company located in Bavla, Ahmedabad, your role will involve the following key responsibilities: - Injectable Production Activities: - Execute and oversee the daily manufacturing of injectable products, whether aseptic or terminal sterilized. - Adhere to batch manufacturing records (BMRs) and standard operating procedures (SOPs) throughout the production process. - Collaborate with QA, QC, and Maintenance teams to ensure seamless operations. - Quality System Support: - Manage QMS tasks including handling deviations, CAPA, change control, and updating documentation. - Participate in investigating and resolving quality events re...

As a Program Manager - Oracle Fusion Cloud at this innovative technology company specializing in AI-powered solutions, your role will involve the following key responsibilities: - Lead the full lifecycle implementation and rollout of Oracle Fusion Cloud (v25) across multiple business units in the ITeS environment. - Establish and manage a robust program governance framework, including PMO dashboards, RAID logs, and KPI scorecards. - Align program objectives with enterprise digital transformation strategy, ensuring delivery within scope, cost, time, and quality parameters. - Manage vendor and Oracle relationships for SLA adherence, patching, and quarterly release upgrades. - Drive change cont...

You will be joining Biocon Biologics, a subsidiary of Biocon Ltd, a global biopharmaceuticals company dedicated to developing high-quality, affordable biosimilars to provide advanced therapies to patients worldwide. As a QMS Compliance Team Member, you will play a crucial role in ensuring manufacturing compliance for biosimilars in the following key responsibilities: **Role 1 Manufacturing Compliance (Biosimilars Compliance):** - Investigate microbial excursions for facility, utility, and process. - Prepare contamination control and strategy documents. - Conduct product quality assessments for microbial contaminations. - Develop risk assessment protocols and reports. - Harmonize procedures a...

Role Overview: You should have a minimum of 5-10 years of experience in Production, R&D, or formulation development activities. As a Production Manager, your primary responsibilities will include proposing and implementing recommendations to enhance efficiency, safety, and quality, supporting new product development projects, controlling production activities, maintaining high standards of housekeeping and cleanliness, monitoring yield losses, minimizing manufacturing costs, reviewing batch records and documents, preparing and reviewing SOPs, providing on-the-job training, coordinating with QA and QC for validation and in-process checks, and ensuring the maintenance of cGMP standards. Key Re...

To ensure preventive maintenance and shut down maintenance is executed as per schedule for Production Blocks, Warehouse, QA & QC. Co-ordination with Cross functional teams & QA for shut down / breakdown related jobs for Production Blocks. Ensure & Execute change control related Jobs (Modification, Process change equipment's) are performed and submit documents within time line. To execute daily walk through for vacuum pump & scrubbing system area. To ensure internal & external compliance of audit observation / IPQA Observations. Every week update by Tracker system. To Prepared Critical Equipment list along with critical spares for all equipment's & Ensure Availability of critical spares in st...

Role Overview: The Project & Change Lead, AVP position at RDA Operation Change team within the CB & IB Ops involves establishing Change & Transformation team to ensure projects meet objectives on time. The PMO Lead provides support services for projects, project managers, project offices or program offices, and helps deliver project tasks while ensuring appropriate application of the project management framework. The team also supports RDA Operations functions in business side activities during joint projects with IT. Key Responsibilities: - Develop & maintain Portfolio/Program/Project Level Governance control procedures for managing portfolio wide initiatives such as Resource Utilization, B...

About the Role: We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our technology platforms, applications, and services. This individual will work closely with cross-functional teams to ensure that all systems impacting regulated data or processes are validated and maintained in accordance with applicable industry and regulatory standards. Key Responsibilities: Lead and execute Computer System Validation (CSV) activities across various GxP-regulated systems and applications. Ensure all software, cloud platforms, and supporting infrastructure comply wi...

As a member of the Central Quality department, your role involves: - Conducting Vendor Audit & Compliances - Reviewing Procurement bill of material (PBOM) - Initiating and evaluating change control, Corrective and Preventive Actions (CAPA) through track wise software - Evaluating Certificate of Suitability (CEP) updation, Drug Master File (DMF) notification, and Vendor notification for implementation at formulation sites - Reviewing Quality Management System (QMS) documents of all sites - Auditing formulation sites as per self-inspection plan - Preparing Audit planner for Active Pharmaceuticals Ingredients, Excipients, packing materials, Key Starting Materials (KSM)/Intermediates, Sterile ar...

As a Computer Operations Manager, you will be responsible for managing the process of analyzing system performance and scheduling to maximize the use of the organization's information processing systems and resources. Your key responsibilities will include: - Prioritizing and scheduling computer operations, code deployment, and workflow to ensure processing equipment and IT resources are utilized efficiently. - Analyzing production, maintenance, and malfunction records to identify issues and implement solutions for improved performance. - Leading, evaluating, and developing the computer operations team to meet production targets. - Collaborating with functional or operational area managers t...

Greetings from Themesoft! We're looking for QMS Support Consultants to join our dynamic team in Chennai . This role focuses on providing L2/L3 functional and technical support for enterprise Quality Management Systems (QMS) , including TrackWise and Veeva Vault Quality , ensuring minimal disruption to critical Quality and Manufacturing operations. Location: Chennai, India Experience: 610 Years Shift Requirement: Must be flexible to work in shifts Notice Period: Immediate to 10 days joiners Expertise Skills: TrackWise , Veeva Vault Quality, Deviation , CAPA , Change Control , Audit Management . Key Responsibilities: Application Support: Handle L2/L3 support for QMS platforms (TrackWise, Veeva...

Amagi is an AI-enabled industry cloud platform built for the new video economy, helping media companies modernize operations, unify streaming and broadcast workflows, and drive advanced monetization. From live remote production and real-time ad decisioning to automated playout and global content syndication. We operate a dynamic content and advertising marketplace and offer fully managed broadcast services that ensure 24/7 reliability and compliance. Trusted by 56% of the Top 50 media companies globally, Amagi powers over 7,000 channel deliveries across 300+ content distributors, processing 500K+ hours of content and generating 26 billion+ monetized ad impressions. Headquartered in Bengaluru...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Job Description Vault Quality DevOps - Perform technical analysis, regression & automation testing Required Skills Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) Job Description R2 Testing Engineer Veeva Vault Quality The Opportunity MSD is an innovative, global healthcare leader committed to improving health and well-being in 140 countries around the world. Our product categories include heart and respiratory health, diabetes, infectious diseases an...

This person will join a cohesive team whose environment thrives on high performance, continual improvement, constant communication, and an open atmosphere. This position is cross-functional, with paths for growth opportunity, and is highly visible to the company, particularly to the CFO and Controller organizations. The audit and compliance function receive high visibility to the CFO and Controller organizations. Job Responsibilities: You will be responsible for designing and executing audit procedures to evaluate the effectiveness of IT General Control and IT Application Controls including configuration and access (segregation of duties) in SAP, cloud and internally developed software appli...

KIMS HOSPITAL SURGICAL CENTER is looking for JR. EXECUTIVE-KIMS-KON-35660 to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports Processing requisition and other business forms, checking account balances, and approving purchases Advising other departments on best practices related to fiscal procedures Managing account records, issuing invoices, and handling payments Collaborating with internal departments to reconcile any accounting discrepancies Analyzing financial data and assisting with audits, reviews, and tax preparations Updating financial spreadsheets and reports with the latest available...

1.Role & responsibilities Preparation and review of Standard Operating Procedures. Issuance, review of OOS,OOT,Deviation,CAPA,Change Control & its Management. To impart internal trainings to DCAL Employees. Review of the Instrument qualifications and re-qualifications protocols of Quality control. Preparation & review of quality risk assessment documents. Review and approval of analytical data related to QA release. Review & Approval of Specification STP, Raw data sheet etc. To review laboratory investigations related to complaints and deviations and to ensure CAPA related to QC are completed within timeline. Internal Audit and External audit Compliance To support RA for analytical assistanc...

Role: Documentation Department: Production Location: Bidar About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal oppor...

As an Access Services General at NTT DATA, your role involves utilizing technical and operational expertise to support and provide recommendations for delivering effective IT services to meet the day-to-day needs of the business. You will work in Hyderabad, Telangana (IN-TG), India (IN) and collaborate with internal and external partners to ensure operational excellence in various areas such as Infrastructure, Network, Workplace, Application, and Security. **Key Responsibilities:** - Consult and recommend necessary actions for the effective operational delivery of core IT Services. - Provide design expertise for introducing new solutions and services aligned with the Business strategy. - Mon...

Date: 7 Oct 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Development Services Job Role Senior Research Associate Job Location - Bangalore About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guideli...

Develop the target state architecture for the most complex projects, which define the end-to-end solution for the most strategic or complex project within ISSQUARED and is utilized as the source of truth for planning and execution across business and technical domains. Document the solutions leveraging existing standards and create new templates where required; present them to project-specific governing bodies for review and approval. Consulting skills are imperative to gain consensus on solutions proposed. Wide knowledge of architecture standards and patterns, a passion for advocating their correct usage and excellent communication skills (written and verbal). Work alongside Development Man...