676 Change Control Jobs - Page 8

Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia , including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines . Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions . Manage regulatory responses to queries and deficiency letters from health authorities and clients , ensuring resolution within timelines. Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation. Lead lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions. Prepare regulatory documents for GMP inspections , tender submissions , and related regulatory filings. Stay updated with regional regulatory developments , including changes in biopharmaceutical regulations and evolving health authority expectations. Provide regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements. Maintain and update regulatory trackers, databases, and dashboards to monitor project status and deadlines. Support the development of regulatory strategies for new product launches and geographic expansion within Asia. Ensure compliance with global and local regulatorySOPs and documentation standards .

1. Preparing and implementing of standard operating Procedures, Batch records, Protocols, cleaning procedures and relevant log sheets. 2. Maintaining documents as per regulatory and cGMP norms. 3. Handling of QMS activities, Change controls, Deviations, Incidents and risk assessments. 4. Responsible for ensuring the department employees for training as per training plan schedule in the TRIMS. 5. Responsible to attend all training programs, SOPs and cGMP trainings relevant to area and equipments. 6. Responsible for monitoring of periodic review of SOPs related to FP Departments and ensuring the completion with in due date. 7. Performing DQ, IQ, OQ, and PQ for the equipments. 8. Writing of relevant Batch documents and log books. 9. Execution of production plan for formulation and filling. 10. Achieving planned FP targets with strict adherence to cGMP. 11. Execution of planned activities of Aseptic Processing Areas like media fills simulation trials, Formulation and filling activities. 12. Execution of preventive maintenance plan for equipments in coordination with Engineering and QA departments. 13. Performing day to day activities as per requirements. 14. Reporting all the activities, deviations and issues to Reporting officer

Oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia, including but not limited to ASEAN, South Asia, East Asia, and Middle East regions. Conduct thorough regulatory reviews of dossier sections (Quality) to ensure alignment with country-specific requirements and ICH guidelines. Coordinate with internal teams RA(CMC), QA, Manufacturing, Clinical Affairs, Local (country specific) and external stakeholders to ensure timely and accurate submissions. Manage regulatory responses to queries and deficiency letters from health authorities and clients, ensuring resolution within timelines. Assess the regulatory impact of proposed post-approval changes and support change control documentation and implementation. Lead lifecycle management activities for approved products, including renewals, variations, labeling updates, and market expansions. Prepare regulatory documents for GMP inspections, tender submissions, and related regulatory filings. Stay updated with regional regulatory developments, including changes in biopharmaceutical regulations and evolving health authority expectations. Provide regulatory guidance on labeling and artwork to ensure compliance with country-specific labeling requirements. Maintain and update regulatory trackers, databases, and dashboards to monitor project status and deadlines. Support the development of regulatory strategies for new product launches and geographic expansion within Asia. Ensure compliance with global and local regulatory SOPs and documentation standards.

We are looking for a skilled MySQL DBA Professional with 5-10 years of experience to join our team in IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in database administration and management. Roles and Responsibility Design, implement, and manage database architectures to support business requirements. Develop and maintain databases to ensure high performance, security, and availability. Collaborate with cross-functional teams to identify and prioritize database needs. Troubleshoot and resolve complex database issues efficiently. Ensure compliance with organizational standards and best practices. Optimize database queries for improved performance and efficiency. Job Requirements Strong knowledge of MySQL database administration and management. Experience with database design, development, and implementation. Excellent problem-solving skills and attention to detail. Ability to work collaboratively in a team environment. Strong communication and interpersonal skills. Familiarity with database security and access control measures. Proficiency in managing large-scale databases and ensuring data integrity.

We are looking for a skilled Kneat CSV Professional with 6-12 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in Recruitment / Staffing and excellent skills in Kneat CSV. Roles and Responsibility Manage and implement Kneat CSV solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain technical documentation for Kneat CSV projects. Provide training and support to clients on Kneat CSV tools and features. Troubleshoot and resolve issues related to Kneat CSV implementation. Analyze and optimize client data processing workflows using Kneat CSV. Job Requirements Strong knowledge of Kneat CSV principles and practices. Experience working with large datasets and complex data processing systems. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong problem-solving and analytical skills. Familiarity with industry-standard data integration tools and technologies.

Development and maintenance of tracking system, api, and module of a project. Producing well-organized, optimized and documented source code based on the specifications. Making frequent changes in the product based on the requirement.. Collaborate with team members for timely delivery of the product. Coordinating with other teams to maintain work flow. Continuously learning and presenting new ideas to improve the work process. Timely reporting and presenting your work. Required Experience, Skills and Qualifications: Must have proficiency in any of the following programming language: C/C++/Python/java Must be technically and logically proficient. Should have good problem solving skills. Excellent debugging and troubleshooting skills. CB.Sc. (CS), BCA/MCA, B.Tech. (CS)/M.Tech. (CS). Fresher/Intern

NKP Pharma is looking for OFFICER / EXECUTIVE / ASSISTANT MANAGER (QC) to join our dynamic team and embark on a rewarding career journey Quality Testing and Inspection:Perform routine and ad-hoc quality tests and inspections on raw materials, intermediate products, and finished goods Utilize various testing methods and equipment to assess product/service quality and performance Record and document test results accurately and in accordance with established procedures and protocols Quality Assurance Procedures:Implement and enforce quality assurance procedures and standards to ensure compliance with regulatory requirements and industry best practices Develop and update quality control documentation, including standard operating procedures (SOPs), work instructions, and quality manuals Identify areas for process improvement and recommend corrective actions to address quality issues Non-Conformance Management:Investigate and document non-conformances, deviations, and quality incidents Collaborate with cross-functional teams to identify root causes of quality issues and implement corrective and preventive actions (CAPAs) Monitor and track the effectiveness of CAPAs to prevent recurrence of quality problems Quality Metrics and Reporting:Monitor and analyze quality metrics and key performance indicators (KPIs) to assess process performance and product/service quality Prepare and present quality reports and dashboards to management and stakeholders Provide insights and recommendations for continuous improvement based on quality data analysis Training and Compliance:Provide training and guidance to staff on quality control procedures, methods, and best practices Ensure compliance with regulatory requirements, quality standards, and industry regulations Participate in internal and external audits, inspections, and quality assessments as needed

3-5 yrs of experience as CRC JD: Preparation of SOP's for operation, establishment of work/trial conduct systems/ training to new joiners/ training to trainers internal trainings, QC Visit of current project remotes, Checking weekly logs, equipment management, market Research

Responsibilities: * Ensure compliance with GMP, GLP & BPR review. * Conduct process validation, cleaning verification & change control. * Collaborate on batch manufacturing & release processes. * Prepare SOPs, BMRs & BPRs.

Greetings from HCL! Currently Hiring for "Compliance" JD: Stakeholder Management Excellent Oral and Written communication. Extensive experience in directly working with customers Periodic Review Hands on experience in conducting Application Periodic Reviews Manage Periodic review processes including scheduling, conducting and reporting of Periodic reviews Documenting process gaps and working with stakeholders to rectify them Experience in analyzing risks and working with stakeholders for mitigations Deviation Performs Deviation Creator role and maintains the Deviation lifecycle and creates identified Deviations as a Deviation record in QMS system Collaborates with multiple stakeholders in recording, managing deviation Supports as required in Route Cause Analysis (RCA) process using QMS specified method to manage Deviation Ensures Deviations are linked to CAPA and Effectiveness Check Ability to communicate and manage multiple stakeholders across different spectrum CAPA Adept in using CAPA management module using TrackWise or any eQMS system Creates requests for Due Date Extension or “Cancellation” requests for CAPA as per the stakeholder request Tracks all CAPA, Deviations to closure without any timeline deviations Provides trend analysis of CAPA to identify patterns and to measure effectiveness check Proactively escalates necessary communications to ensure CAPA is timely managed Proactively communicates and excels in stakeholder management Supplier Assessments Extensive knowledge and experience in conducting supplier assessments Experience - 5-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with update resume Candidate Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda.baby@hcltech.com

QMS documentation, handling change control, incident, deviation, OOS,OOT,CAPA; preparing and reviewing BPR, BMR, SOP, STP, COA & other protocols; handling market complaints; process validation.

RoleKMIL - Monitoring Requirement2 Gender- Male/ Female both are preferred Education Background- CA / MBA (preference would be MBA- Finance) Experience level - 3 to 5 years (relevant experience not required) Preferred profile- Risk team of retail or wholesale division of any Bank / NBFC. The Key profile of Monitoring & Policy Risk Analyst is to carry out Risk Assessments for Pan India CRE Lending Portfolio is laid down below for your reference . Key responsibilities include Implement effective risk management processes for the Construction Finance business verticals to identify potential risk in the underwritten portfolio and ensure portfolio health Carry out background research and gain a thorough understanding on the project, the developer and the regional market, highlighting any negative reports so as to ensure the quality of the invested portfolio. Track the progress of the project and monitor disbursement as per the project lifecycle. Ensure that the disbursement milestones are achieved as per the underwritten sanctioned conditions. Recommend policy amendments/ refinements based on regulatory and market changes Undertake automation of existing processes by liaising with the IT department Prepare various dashboards and reports such as Monthly and quarterly portfolio monitoring report Overdue Analysis Early Warning Signals r eview Deviation Analysis Analytical Insights like Limit/ Renewal Management, Covenant/ PDD Management Trends analysis of the regional P ortfolio Perform various monitoring activities such as NOC issuance- Due diligence for the Monitoring and instruct for Escrow SI Threshold Map collections with the Escrow credits on regular intervals.

Role & responsibilities To review that all relevant quality management systems of Hosur manufacturing site are implemented and well maintained. To review, monitor and improve Quality performance of Hosur manufacturing site. To promote quality attitude, awareness, and mindset of the site by all proper means including training to the cross functional team members. Implement, audit, and develop quality management system, in line with Global quality policy/ manual and procedures relevant to area. Ensure the required process controls are in place wherever they are necessary. To review that testing and inspection of all raw materials, packaging materials and finished goods are carried out as per documented testing procedures and specifications. To review that the release of all raw materials, packaging materials, bulk as per approved SOP before they are used for further production activities. To review the release process of all finished goods as per approved SOP and global requirements including GFS before they are released for distribution. To review all RM and PM used in manufacturing process are from approved suppliers and with the required quality before it reaches Hosur manufacturing site including COA verifications against the documented specifications. To review all the internal lab/ External labs are conducting the testing processes as per the documented procedures and specifications. Ensure appropriate investigation are carried out throughout the manufacturing site in case of any quality related issue and ensure the corrective and preventive actions are implemented to mitigate the identified root causes for the quality issue. Ensure the preparation of training calendar and adherence to the same. To support and conduct self-inspection quality audits across all the QMS areas and continuously improve the QMS implemented at site. To ensure that all audit points/recommendations highlighted in the audit reports are followed up and closed effectively as per the agreed timelines. Review the performance of suppliers on a regular basis. To support all key initiative at the site as key member of the site. To support the site in conducting management review meetings as per the schedule. To accept and execute other responsibilities assigned by the management time to time.

Job Title:- KMIL- Wholesale Banking- Risk Monitoring Analyst Grade:- M4/M5 Location:- Mumbai Track financial and project performance covenant: Monitoring financial and project performance against predefined convenants. Identify deviations and promptly communicate findings to relevant stakeholders. Project performance analysis: Conduct through analysis of project performance metrics. Provide insights and recommendations to mitigate risks. Track Compliances to sanctions conditions: Moniotor compliance with sanctions conditions imposed on credit facilities. Take proactive measures to address any non- compliance issue Site Visit: Conduct on site visit to assess the progress and status of projects. Documents observations and report findings to management Compliance with RERA regulations: Ensure adherence to regulatory guidelines and internal policies. Stay updated on regulatory changes and implement necessary adjustments. Early warning signal tracking: Identify early warning signal as per the existing policy indicating potential credit risks. Collaborate with relevant teams to develop strategies for risk mitigation. Coordination with business and credit underwriting team Liaise with business units and credit underwriting teams to gather relevant data and insights. Collaborate on credit risk assessment and monitoring activities. Job Requirement- MBA with 5 to 8 Years of experience is preferred

Role & responsibilities Audit Trail Review Batch Release Method Validation & Transfer Review Calibration Records Review Analytical Raw Data Issuance OOS, Lab Deviation CAPA QC Review Experience in handling audits Preferred candidate profile Should have participated in Audits and exposure towards it Should be qualified in Chemistry knowledge in process and production Smart enough to understand the regulatory requirements Knowledge in regulatory and GMP. Perks and benefits As per Company norms

The job is to support Crisil's client, a Singapore based Asset Manager, by assisting the central team "Process Centre of Excellence" in the Pune office. Your main responsibilities include: - Supporting the vision and roadmap for maturing Process Management for the client in alignment with their strategic initiatives. - Assisting in the design and execution of process management activities such as Process Governance, Change Control, Quality Control, and Continuous Improvement. - Implementing and standardizing process management and excellence across the client's organization. - Collaborating with various departments like Process Owners, Technology, Data, Risk, etc., to enhance client processes through re-engineering, digitization, and automation. - Providing advice to Process Owners on best practices for Process Design & Governance. - Assisting the PCoE Head in organizing Process Forum meetings and supporting Process Governance & Reporting. - Maintaining a thorough understanding of the client's process universe and dependencies. - Acting as the custodian of Process Artefacts by managing master lists, updating process documents, and overseeing document access. - Monitoring process improvement initiatives. Experience/Qualifications: - Should be a team player with strong collaboration skills and the ability to build trust with a broad range of stakeholders. - Proficiency in process improvement methodologies like Lean, Six Sigma, process mapping, and related tools. - Excellent analytical, problem-solving, and project management abilities. - Strong communication, presentation, and stakeholder management skills, with the capability to work effectively with cross-functional teams. - Business knowledge in at least one of the following areas: Distribution, Investments, Finance, and Risk (including Legal & Compliance). - A bachelor's degree or equivalent level of education.,

Q Team Member Job Type: Contractual Job Location: Pan India Experience: +1 years Profile Summary: Ensure the quality of training Center and Hostel operations. Their duties include developing and implementing quality control tests, inspecting at various stages and writing reports. The ideal candidate is an exceptionally organized, methodical professional with the experience necessary to take our project to the next level with respect to accuracy, security, and safety. Job Responsibility: Share inspection report and advisories with SRLM/CTSA Carry out the inspection Follow up for compliance supervising the process and make sure to meet standards monitoring all the operations for center coordinating with center manager Document quality assurance activities Develop new standards, with improvements as needed Skills: E SOP certified ms office Min. Education: Graduate Apply Job Type: Contractual Job Location: Pan India Experience: +1 years

Handling of Document issuance, BMR / BPR issuance, Change control, deviation, Control (Retain) Sample management, SOP issuance/ Document archival and retrieval, Issuance Management of Doc Cell., Internal audit activities,

Role & responsibilities (Production): Assist in manufacturing operations of parenteral dosage forms (sterile injections) as per SOPs and GMP guidelines. Monitor and record process parameters during manufacturing and filling operations. Ensure compliance to cGMP, documentation and data integrity norms. Support continuous improvement initiatives in production efficiency and compliance. Role & responsibilities (Engineering): Assist in preventive maintenance and breakdown handling of production equipment Support engineering team in equipment qualification and calibration activities. Monitor Utility systems Maintain proper documentation as per GMP norms. Follow safety protocols and support new initiatives Preferred candidate profile Basic knowledge of sterile/aseptic manufacturing / pharma production equipment Interest in plant maintenance Willingness to work in shifts & controlled environment Good documentation and communication skills Attention to detail and compliance mindset Good observations and analytical skiils

Your responsibilities include, but are not limited to establishing the optimal master production schedule for the tactical horizon from month 3 to 24 months. This involves determining production volumes based on demand, conducting rough cut capacity analysis, and allocating resources to anticipate operational costs and inventory levels. You will ensure that customers have clear visibility of the current valid supply plan and monitor delivery commitments in accordance with Service Level Agreements (SLAs). Coordinating action plans to address resource constraints and managing supply Key Performance Indicator (KPI) reporting and analysis will be part of your duties. You will also be responsible for maintaining the right level of SKU inventories at the next point of the supply chain. Confirming supply orders and production orders at the entry point of the time fence is essential. It is crucial for you to continuously expand and apply process and SAP knowledge to leverage the value of the integrated SAP system effectively. You will establish, maintain, and implement integration and reconciliation activities between Global Technical Operations Supply Chain and Finance. Monitoring, controlling, and improving supply chain processes, managing a portfolio of supply chain projects, and ensuring compliance with relevant regulations are key aspects of the role. Collaborating closely with stakeholders such as CTC Country Managers, regional Head of Logistics, and Supply Chain Management (SCM) in your area of responsibility is vital. You will support regional logistics functions, identify and implement cost-saving opportunities, and facilitate Supply Review Meetings. Additionally, you will actively participate in the SOP process and manage demand control activities while providing inputs to Master Planning Schedule (MPS) and detailed scheduling. Leading the implementation of Life Cycle (LC) projects to ensure compliant drug supplies and maintaining a detailed Change Over Plan (COP) for LC projects will be part of your responsibilities. Requirements: - Functional Breadth - 10+ years of relevant experience - Project Management - Operations Management and Execution - Collaborating across boundaries Skills: - Business Networking - Business Scenario Planning - Change Control - Continual Improvement Process - Efficiency - Flexibility - General HSE Knowledge including GDP - Inventory Management - Knowledge of GMP - Operations - Order Fulfillment - Order Management - Procurement - Product Distribution - Risk Management - Supply Chain - Supply Chain Planning - Supply Planning - Supply-Chain Management Join us at Sandoz, a leader in the Generic and Biosimilar medicines industry, as we aim to provide high-quality medicines to patients worldwide through innovation and collaboration. Experience an agile and supportive work environment where personal growth is encouraged and diversity is embraced!,

As the Section Head - Batch Release QA at Sun Pharmaceutical Industries Ltd, located in Halol (OSD), you will be responsible for overseeing IPQA activities and developing strategies in alignment with Sun Pharma Compliance, Product Quality Management objectives, and Regulatory requirements. Your role will involve planning and coordinating internal and external departmental support for quality assurance activities as per approved protocols and quality systems. You will be tasked with identifying and implementing solutions to enhance existing site quality assurance systems and processes, as well as managing batch release functions at the site. Your key responsibilities will include ensuring compliance with regulatory requirements related to products, processes, equipment, and release procedures, managing batch release activities for commercial dispatch, reviewing and approving investigations and CAPA, executing change control and risk assessment processes, and maintaining quality metrics reports as per specified timelines. You will also be responsible for coordinating with Quality Persons (QPs) and customers from different regions for batch release, managing technical agreements, overseeing warehouse and BSR operations, and handling retain sample storage, inspection, and life cycle management. To excel in this role, you are required to possess a minimum educational qualification of M.Sc/M.Pharm/B.Pharm along with at least 15 years of work experience. It is essential to have a strong knowledge of GxPs, cGMP, and other regulatory requirements, as well as demonstrate skills in planning, prioritization, collaboration, accountability, compliance, and customer service orientation. Additional attributes such as people connect, attention to detail, emotional control, effective communication, and problem-solving capabilities will be beneficial for your success in this position. In terms of the working environment, you will be working in both normal office settings and non-aseptic manufacturing/packaging environments. You should be prepared to work in areas with moderate to loud noise levels, comply with gowning requirements for controlled non-aseptic manufacturing areas, and wear personal protective equipment as necessary to ensure safety and compliance with GMP requirements.,

As a Production Manager, you will be required to have a B.Sc./M.Sc./B.Pharm/M.Pharm qualification with FDA approval in topical preparations. With a CTC of 7 to 8 lac per year, you will be expected to work in 8-hour shifts and possess 10 to 15 years of experience in topicals. Your primary responsibilities will include production planning in accordance with clients" purchase orders and ensuring its successful execution. You will be accountable for verifying the dispense of raw materials, maintaining and updating the Production Module on the PERP system, and overseeing the manufacturing of cream, ointment, and lotion. Moreover, you will be responsible for implementing production operation instructions, managing in-process control, and conducting online documentation such as Batch Manufacturing Records (BRM), Batch Production Records (BPR), and logbook updates. It will also be part of your duty to maintain calibration, validation, and related documents, handle change control and deviations, and ensure the preventive maintenance of equipment is up-to-date. In case of incidents, you will lead investigations, provide training to new recruits, and coordinate with Quality Assurance (QA), Quality Control (QC), and Store Departments. Moreover, you will oversee the up-gradation of the PERP system and its accompanying documents while supervising all manufacturing activities to ensure smooth operations.,

As a global leader in sustainable engineering, architecture, and environmental consulting, Stantec is committed to driving innovation and redefining what's possible. With approximately 32,000 employees across 6 continents, we are dedicated to advancing communities worldwide. We are currently seeking a Senior Project Controller to manage portfolios and large projects, focusing on scheduling, cost control, and mentoring team members. In this role, you will support project managers and leads by developing and analyzing integrated CPM schedules, monitoring project progress and costs, and preparing project progress reports. Your responsibilities will include identifying challenges, training needs, and ensuring team success. The ideal candidate will have a Bachelor's degree in Civil/Construction/Mechanical Engineering, a Post-Graduation in Construction Management, and 12 to 20 years of professional experience. A PMP Certification would be preferable. Experience in project controls, scheduling, and cost engineering will be advantageous. Strong communication skills and the ability to collaborate with project managers are essential. Key Responsibilities: - Manage major projects and portfolios - Develop and analyze integrated CPM schedules - Monitor project progress, costs, and earned value - Prepare project progress reports and specific reporting requirements - Collaborate with project managers to ensure work products meet Stantec standards - Drive project design management and coordination with project teams - Stay updated on industry technology, project management concepts, and tools - Willingness to work flexible hours to enable global collaboration Qualifications: - Bachelor's degree in Civil/Construction/Mechanical Engineering - Post-Graduation in Construction Management - PMP Certification (preferable) - 12 to 20 years of professional experience - Knowledge of Primavera P6 (advantageous) - Competence in MS Office applications Join us at Stantec and be part of a team that is shaping the future of sustainable engineering and environmental consulting. Be prepared to think beyond the conventional and contribute to redefining what's possible in communities worldwide. Please note that the primary location for this position is in India, Pune. This is a full-time, regular position with no travel required. If you are ready to take on this exciting opportunity, apply now and be part of our dynamic team at Stantec.,

Role & responsibilities Incharge for QMS activities, Preferred candidate profile Should have good knoledge about QMS, Validation, calibration , qualification, re-qualification, change control. CAPA, OOS, OOT & Investigation. Mainly for all Process equipments and Utility ( HVAC System, Purified System, Refrigerator System, Air Compressor System & Boiler ) Exposure with Regulatory Aduits.

Responsibilities: * Implement Change Control procedures during deviations/CAPAs. * Conduct BPR reviews, BMR analysis, GMP compliance checks. * Ensure product quality through process validation and CAPA implementation.