682 Change Control Jobs - Page 20

Assists in the maintenance of registrations and licenses of the products in RA systems and database such as SharePoint and other team folders as necessary. Performs labelling reviews and assisting in project creation in the Artwork Management system (WebCenter) as needed. Ensures timely submission of in renewal, site registrations and minor product submissions to relevant Health Authorities in APAC countries. Ensures effective communication across RA (top-down and botom-up) Ensures timely Veeva Vault update related to LCM activities such as MA renewal, site registration, and other minor product submissions as needed. Supports in the request of samples collection via K2 system. Generates regional reports, process vendor payments and other country-related requests. Provides support on other country regulatory and cross functional activities as necessary. Conducts timely regulatory intelligence search in the relevant countries and update Country Regulatory Tool system as necessary. Takes part in Regional/Global or local hub initiatives that are relevant to support the region and hub. Supports the review and revision of hub processes to achieve efficiency across hub. Able to travel as per business need. Other Activities: a) Strategy Alignment -For Site Registration submissions only, ensures alignment with country on submission strategy as required. b) Dossier Readiness - Performs labelling reviews and assists in project creation in Artwork Management system. c) Application Submission - Supports country in renewal and minor product submissions to relevant Health Authorities. - Assists overall the maintenance of registrations and licenses of the products in RA systems and database. - For Site Registration submissions only, ensures timely submission/dispatch of the dossier related to submission and timely Veeva Vault updates. d) Application Approval - Supports country in renewal and minor product submissions to relevant Health Authorities. - Assists overall maintenance of registrations and licenses of the products in RA systems and database. e) Product Maintenance - Assists overall hub in the maintenance of registrations and licenses of the products in RA systems and database. f) Others - Provides support on other country regulatory and cross functional activities. - Generates reports, request samples collection, process vendor payments Who you are: Bachelors or Masters in Pharmacy OR p.HD Min 5-10 Years of experience in Indian Regulatory Market Fluent in written and spoken English Experience in CDSCO, Import and State FDA

Responsibilities: * Maintain inventory levels * Perform basic cleaning & change control procedures * Report equipment issues promptly * Assist with OOS investigations when needed * Clean office space regularly Health insurance Annual bonus

Sodexo Food Solutions India Pvt. Ltd.ces is looking for MIS Admin Assistant to join our dynamic team and embark on a rewarding career journey Oversee the design, implementation, and maintenance of the information systems, including hardware, software, and networking infrastructure Manage the database systems, including data backup and recovery, data security, and data integrity Develop and maintain procedures for managing the information systems and technology infrastructure, including disaster recovery plans, security policies, and user access controls Analyze the business processes and identify opportunities for improvement through the use of information systems and technology Collaborate with cross-functional teams, including IT, finance, and business operations, to integrate information systems and technology with other systems and processes Monitor system performance and provide technical support to end-users to ensure the smooth operation of information systems and technology Strong analytical and problem-solving skills Excellent communication and collaboration skills

Role & responsibilities J ob Summary We are seeking an individual for the Quality Assurance team, responsible for ensuring line clearance, material verification, and conducting in-process checks according to batch manufacturing and packing records. The role includes timely sampling/testing, coordination in cleaning validation, and ensuring compliance with technology transfer and exhibit batches, including the review and certification of batch records. Roles & Responsibilities • You will be responsible for performing line clearance, material verification, start-up checks and in-process checks as per the batch manufacturing record, and batch packing record. • You will be responsible for the timely sampling/testing of In-process, reserve, and finished samples and stability samples/environmental monitoring. • You will be responsible for coordination in cleaning validation, performing sampling and compliance. • You will implement and comply with Technology Transfer and initiation of exhibit batches. • You will review batch manufacturing and batch packing records and certification of the same after execution. educational qualification: A Bachelors degree in Pharmacy, Chemistry, Chemical Engineering, or a related field Minimum work experience : 4 to 7 years of experience in pharmaceutical manufacturing or a similar role Technical Skills • Knowledge of microbiology and aseptic practices, cleaning validation activities, sampling and relevant standards. • Proficiency in performing line clearance, material verification, start-up checks, and in-process checks following batch manufacturing and packing records. • Experience in timely sampling and testing of in-process, reserve, and finished samples, as well as stability samples and environmental monitoring. • Skilled in reviewing batch manufacturing and batch packing records, ensuring accuracy and certification after execution. Behavioral Skills • Attention to detail in performing line clearance, verification, and record reviews. • Skilled in time management and coordination for sampling, testing, and execution of batch manufacturing and packing activities. • Communicates effectively with team members and stakeholders regarding batch-related activities and compliance. • Applies problem-solving skills in addressing issues related to line clearance, sampling, and record certification. • Demonstrates a focus on maintaining high-quality standards and adhering to regulatory compliances in manufacturing processes.

Role & responsibilities Lead the vendor qualification process, including the evaluation and approval of new and existing vendors. Review and approve vendor documentation to ensure compliance with internal standards and regulatory requirements. Manage QMS notifications, ensuring timely resolution of issues related to change control, deviations, and CAPA. Oversee the preparation, review, and approval of SOPs to ensure alignment with current practices and regulatory standards. Conduct comprehensive risk assessments and risk analysis to identify potential quality issues and implement mitigation strategies. Independently plan, conduct, and report on vendor audits, coordinating with internal and external stakeholders to schedule and execute audits. Preferred candidate profile Bachelors or Masters degree in Pharmacy from a reputed institution. Should have 10 -15 years in corporate quality assurance roles within the pharmaceutical, biotechnology, or related industries. Should be proficient in quality management software such as Trackwise, Caliber, SAP, TMS, DMS, and QAMS. Should have experience in vendor qualification management, vendor documentation and managing vendor audits.

JD: Mandatory Skills - ITIL, CSV, Process Management, Change Management, Pharma, audit, Compliance & Any certificate ITIL V3 / ITIL V4, CAPA, RCA Global Quality IT Manager Act as SME for review Quality Incidents, Change Controls, CAPA;s and procedures for IT systems. Responsible for review/Approval of stand Alone/Enterprise GxP Computerized systems validation documents, including enhancements. Responsible for review/approval of IT infrastructure qualification documents, including enhancements. Author & review CS-VMP and associated protocols & report templates. Conduct trainings in the areas of (CSV SOPs and related topics) to develop in-house capability. Support audit/assessment of suppliers of GxP IT Computerized Systems as SME. Support Audit preparation and remediation activities, as appropriate. Responsible for Monthly Reporting, as applicable. Support IT Compliance/Data Management/Data Security & Data Integrity for GxP computerized systems. Conduct Self Inspections for IT Compliance, establish CAPA to correct deficiencies and ensure closeout. Coordinate with the cross functional team to ensure timely initiation and closure of all QMS activities Viz., Incident, CC, CAPAs, as applicable. Report and escalate issues, as situation demands. Perform other duties, as assigned.

To ensure that all raw materials (API & excipients) are sampled, tested, and released. Key Responsibilities: 1. Sampling & Receipt 2. Testing & Analysis 3. Documentation & Release 4. Compliance & Audit Readiness 5. Instrument Handling Required Candidate profile Candidate must have experience in handling team of minimum 10 members. Candidate must have experience into routine analysis of raw material and QMS knowledge.

FinalReview.in is looking for an experienced Finance Professional to lead and help build our Strategic Finance team. This is a rare opportunity to build a growing team from the ground level up and drive analyses for some of the most exciting initiatives and decisions underpinning FinalReview.in growth. In this role, you will partner closely with Product senior leadership on business priorities that will have a critical impact on our company s near and long-term success. Apply for this position Allowed Type(s): .pdf, .doc, .docx By using this form you agree with the storage and handling of your data by this website. *

GSA Industries India Pvt Ltd 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.

Job Description 1. Preparation of SOPs of QA, review of other departments' SOPs, 2. To perform batch release of API material and review of related documents. 3. To prepare and review Quality Risk Assessment, Site Master File, Hold Time Study Protocol/Reports, and other study protocols/reports, Specifications, Stability Protocol, and Stability Report Data. 4. Review of Validation Master Plan. 5. To review the analytical method transfer protocol/report and method validation documents of the API. 6. To ensure and handle the investigation of out-of-specification Results, OOT, Deviations, Product failures, and Market Complaints. 7. To review Quality system documents such as Deviation, Change control, CAPA, OOS, OOT, re-processing, Re-work, market complaints, and market returns. 8. To review Qualification Protocols/Reports of product, equipment, and facility. 9. To Review of the Annual Product Quality Review. 10. To review of Master Document, such as BPR, Test and Calibration Data Sheet, Test Procedures, and Microbiological Test Procedures. 11. To collect, review, and submit documents to the RA Department for dossier preparation /Regulatory Submission. Work Experience 5 to 8 Years Education Post Graduation in Chemistry Competencies

BUILD CAREER WITH CHIRON ! WALK IN INTERVIEW On 20 June 2025, Friday TIME: 10:00 AM to 2:00 PM Quality Assurance / Quality Control Experience 2 5 Years 1. Quality Assurance Qualification: M. Pharm / B.Pharm / B.Tech (Micro/Biotech/ Botany) IPQA/ Change Control/ DR/ CAPA /BMR/SOP Process & Cleaning Validation APQR / QMS Sterile aseptic operation Good Subject Knowledge Legible Handwriting. 2. Quality Control Qualification: M.Sc/ B.Sc Microbiology Environmental Monitoring Media Preparation Bioburden testing Positive Mindset Good Subject Knowledge Legible Handwriting Documents need to Carry Updated Resume ID Proof (Aadhaar & Pan card) Passport Size Photo Copies of Highest Educational Qualification Current company Appointment letter/ Increment letter Last 3 month Pay slips & Bank statement Previous company experience & relieving letter

We are seeking a meticulous and experienced Manager Quality Control to lead and enhance our quality control operations at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in overseeing all aspects of quality control, ensuring adherence to Good Laboratory Practices (GLP), and maintaining a robust Quality Management System (QMS). Your expertise will be crucial in driving Analytical Method Development, managing CAPA and Change Control processes, and upholding Data Integrity standards. You will lead a team of QC analysts, providing training and mentorship to foster a culture of excellence. The ideal candidate will possess a strong understanding of ICH Guidelines and Regulatory Compliance, with hands-on experience in GC and HPLC. This role demands a proactive approach to QC process improvement, meticulous QC documentation, and the ability to conduct thorough analytical data reviews. Job Details: Industry: Active Pharmaceutical Ingredient (API) Department: Quality Control Role: Manager - Quality Control Location: Visakhapatnam Compensation: 12 -15 LPA Experience Required: 10 - 15 years Employment Type: Full-time Required Qualification: Bachelor's degree in Chemistry, Pharmacy, or a related field Responsibilities: Analytical Method Development and Validation Lead the development, validation, and transfer of analytical methods for API testing in compliance with ICH and regulatory requirements. Review validation protocols and reports, ensuring accuracy and completeness. Troubleshoot analytical challenges and provide technical guidance. Collaborate with AR&D to optimize methods for both new and existing products. Ensure complete documentation of method development and validation activities. Quality Management System (QMS) and Compliance Maintain and improve the QMS to comply with regulatory standards (US FDA, EU GMP). Oversee CAPA and Change Control processes to address quality deviations. Conduct internal audits to ensure procedural compliance and identify improvement areas. Ensure adherence to Data Integrity principles across QC operations. Serve as the key QC contact during regulatory inspections and audits. Laboratory Operations and Equipment Management Supervise daily QC laboratory operations and ensure efficient sample testing. Oversee calibration and maintenance of laboratory instruments (GC, HPLC). Monitor lab environmental conditions and implement corrective actions where needed. Ensure sufficient availability of reagents, standards, and consumables. Implement lab safety procedures and optimize workflows to improve turnaround time. Team Leadership and Performance Management Lead and mentor QC analysts, fostering a collaborative and improvement-driven culture. Conduct performance evaluations and provide development-focused feedback. Design and deliver technical training programs to enhance team capability. Assign responsibilities to ensure a balanced workload and accountability. Address employee concerns and promote a positive, inclusive work environment. Data Analysis and Reporting Oversee review and interpretation of analytical data for compliance and reliability. Approve QC reports including Certificates of Analysis (CoAs). Identify trends and take proactive measures to address quality concerns. Present QC metrics and insights to management and cross-functional stakeholders. Maintain accurate records and use statistical tools to evaluate data. General Expectations and Past Experiences: Strong understanding of pharmaceutical QC principles and global regulatory standards (US FDA, EU GMP). Demonstrated expertise in analytical method development and validation with hands-on experience in GC and HPLC. Proven track record of maintaining QMS aligned with ICH guidelines. Experience managing CAPA, Change Control, and Deviation processes. Deep commitment to Data Integrity and documentation compliance. Strong leadership skills with a track record of mentoring high-performance teams. Excellent interpersonal, communication, and analytical problem-solving abilities.

Job Title: IT Regulatory Reporting Governance Coordinator Corporate Title: AVP Role Description The IT Regulatory Reporting Governance team provides an essential 24x7 service to manage IT regulatory reportable events related to IT incidents. The team is responsible for coordinating with IT stakeholders to assess, classify and ensure timely and accurate reporting to regulators. The team operates with a high level of expertise and coordination to manage the complex regulatory landscape effectively. A significant portion of the team's work involves ensuring compliance with the European Supervisory Authority (ESA) Digital Operational Readiness Act (DORA), which sets a new standard for regulatory reporting. However, the team's scope extends beyond DORA to include support for additional regulatory requirements including but not exhaustive of MAS, FSS, US Regulators, US Fed, FSA, HKMA. The IT Regulatory Reporting Governance Coordinator will play a vital role in supporting the operational execution of the IT Regulatory Reporting process. This position involves assessing and classifying incident data to identify events that may require regulatory reporting, as well as preparing and submitting accurate regulatory reports. Additionally, the role includes providing oversight and conducting four-eye checks to ensure the accuracy and completeness of these reports. The IT Regulatory Reporting Governance Coordinator will also be responsible for identifying potential service improvements and associated risks, contributing to the overall efficiency and effectiveness of the reporting process. This role is integral to ensuring Deutsche Bank meets its regulatory obligations efficiently and effectively, while also supporting continuous improvement and risk management within the regulatory reporting process. Your key responsibilities Executing the regulatory reporting process in adherence with all Deutsche Bank charters, policies, key operating procedures, and key operating documents. Performing initial assessment and classification of data to support the identification of potential regulatory reportable events and preparing draft reports. Preparation and responsibility for the submission of accurate regulatory reports to the Regulator. Oversight/Four-eye checks to ensure the accuracy and completeness of regulatory reports. Identifying risks related to regulatory compliance, support processes and controls, ensuring escalation where required. Contributing to Continual Service Improvements. Undertaking reporting activities to support monthly service reports. Participating in OnCall/Weekend/Bank Holiday working where required. Your skills and experience Essential - Excellent communication skills, both written and verbal. Essential - Effective team collaboration and interpersonal skills. Essential - Ability to work well under pressure and meet tight deadlines. Essential - Demonstrable experience in financial reporting, preferably within a regulated industry. Essential - Ability to extract and analyse data with attention to detail to identify if Regulatory Reporting triggers have been reached. Essential - An ability to navigate ambiguity Desired People Management experience. Desired - An understanding of Incident & Problem Management processes. Desired - Awareness of IT regulations applicable to financial institutions.

Role & responsibilities 1. Monitoring and Managing the Quality Management System (QMS) Oversee the effective implementation and maintenance of the QMS across all departments. Ensure compliance with regulatory standards such as GMP, GLP, and ISO guidelines. Regularly review and update QMS documentation to reflect current practices and regulatory changes. Facilitate continuous improvement initiatives within the quality system. 2. Participation in Compliance, Investigations, and CAPA Effectiveness Lead investigations into quality deviations, non-conformances, and product complaints. Implement Corrective and Preventive Actions (CAPA) to address root causes. Verify the effectiveness of CAPAs to prevent recurrence and ensure product quality. 3. Preparation and Review of Quality Meetings and Documentation Prepare comprehensive reports for quality review meetings. Review and approve documentation related to technology transfers, validation, and process changes. Maintain accurate records to support regulatory audits and inspections. 4. Handling Non-Conformances and document issue,retrieval and storage: Escalate non-conformances promptly and coordinate remediation activities. Ensure document issue, retrieval and storage of documents. 5. Ensuring Good Documentation and Manufacturing Practices Enforce adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) Conduct regular training sessions for personnel on quality standards and documentation procedures. 6. Timely Closure of QMS Documents Ensure all QMS-related documents, including CAPA reports, change controls, market complaints and deviations, are closed within stipulated timelines. 7. Standard Operating Procedures (SOPs) and Training Develop, review, and update Standard Operating Procedures (SOPs) for various quality processes. Conduct training on SOPs and quality practices for staff to ensure consistent compliance. 8. Preparation and Maintenance of Regulatory Documentation Responsible for preparing and maintaining the Site Master File (SMF) in accordance with regulatory requirements. Support regulatory audits by providing accurate and timely documentation. 9. Implementation of Data Integrity Procedures Ensure strict adherence to data integrity principles across all quality data. Conduct periodic reviews and audits to verify data accuracy and compliance. 10. Audit Compliance and Continuous Improvement Maintaining audit readiness is a key aspect of this role. You will be responsible for ensuring compliance during internal and external audits, identifying areas for improvement, and implementing corrective actions to enhance overall quality systems. Preferred candidate profile Proven experience (10+ years) in QA/QMS within the pharmaceutical industry, especially in API and formulations. Strong knowledge of GMP, GLP, ISO standards, and regulatory requirements. Experience in handling QMS documentation, CAPA, deviations, market complaints and change controls. Excellent communication, leadership, and training skills. Ability to manage multiple projects and meet strict deadlines.

JOB RESPONSBILITIES ON QUALIFICATION OF EQUIPMENT, FACILITY & UTILITIES - QA RESPONSIBILITIES: Ensuring of preventive maintenance of all equipments carried out as per schedule. Review of calibration certificates. Review of all equipment and utilities qualification documents (URS,IQ,OQ and PQ). Review of requalification protocol and reports for all equipments as per schedule. Review of temperature mapping protocol and report as per the schedule. Preparation of product quality review as per SOP. Review of preventive maintenance and calibration schedules and checklist. Issuance, retrieval and archival of registers to respective departments. Line clearance for equipments, clean room area and repacking area during product-to-product change over. Review of Water analysis reports and Microbiology reports. Ensure Data integrity. Conducting trainings. Review and compliance of engineering department and conducting GMP walk through audit. Preparation and review of Standard Operating Procedures. Involving in investigations and review of Deviations and others QMS activities. Involving in Internal audits. Handling of document control system.

Title : REF72864X - Sharepoint Admin (3 to 5 years) - Mumbai - Assistant Manager TS Manage the overall health, performance, and availability of the SharePoint environment, ensuring optimal uptime and user experience. Configure and maintain SharePoint sites, lists, libraries, and other components to support business processes and collaboration needs. Customize and configure SharePoint sites, workflows, forms, and applications based on business requirements, using out-of-the-box features and SharePoint Designer.. Implement and manage user access controls, permissions, and security settings to ensure data integrity and compliance with Corporate Travel Managements policies. Monitor and audit SharePoint access to identify and mitigate security risks. Plan and execute SharePoint upgrades, patches, and migrations, ensuring minimal disruption and adherence to best practices. Monitor system performance, diagnose and resolve issues, and implement optimization strategies to enhance SharePoint performance and scalability. Maintain detailed documentation of SharePoint configurations, changes, and procedures. Generate regular reports on usage, performance, and adoption of SharePoint services. Qualifications Bachelor' Degree Additional Information 24X7 rotational shifts Work from office No cell phone policy Leaves as per client calendar Location - Mumbai (Vikhroli). However, we will be shifting to Thane in few months. Job Location

Position Assistant Manager-QA Function QA Location Bharuch;;;;;;; Reports to Head QA Summary of Job (Purpose/ objective of the job Department organogram to be enclosed) To check the Quality Assurance of the products and ensure compliance with the SOP's. Key Responsibilities (Performance Indicators) Quality professional of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement and API Manufacturing, Quality Management System (QMS), Qualification, Validation and other Manufacturing functions.; Documentation and Handling i.e.: Integrated Management System (IMS) (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018), WHO-GMP, FSMS (ISO 22000), FAMI-QS, Energy Management System (EnMS), Halal, Kosher and Responsible Care and regulatory (FDCA, USFDA, MHRA).; Expertise in change control, deviation, market complaint, non-conformance investigation, vendor audit, self-inspection, gap assessment, customer audit, training, vendor management, vendor questionnaire, validation, equipment and utility system qualification. Issuance and retrieval of Batch Manufacturing Records. Control and Issuance of formats. Ensure that retention of various documents, reports and records are as per documented procedures. Issue copy of Master Batch Production Instructions to production for batch manufacture and review critical control parameters before release of the batch. No. of Reportees NA Qualification and Experience M.Sc Organic Chemistry with 3-6 yrs Key; Competencies ( Technical, Functional and Behavioral) Integrated Management System (IMS) (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018), WHO-GMP, FSMS (ISO 22000), FAMI-QS, Energy Management System (EnMS), Halal, Kosher and Responsible Care and regulatory (FDCA, USFDA, MHRA). Knowledge of validation process. Practical experience in documentation as per various audits. Approval VP - Mfg Unit HR

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

Works independenly on creating test plans, executing tests, troubleshooting the issues, automating test cases, reporting bugs with all the required details, reviewing the tests, providing the test reports, analying test failures Capable of analyzing moderately complex challenges using analytical tools and data interpretation. Applies critical thinking to assess problems with relevant data independently to evaluate potential solutions after considering various possibilities. Engages in independent analysis and collaborates with others to gather insights and develop recommendations including challenging existing processes. Capable of working independently while actively contributing to team and organizational goals, with a growing ability to influence outcomes beyond department Incorporates and promotes new technology to improve data analysis, reporting and problem solving. Analyzes team processes to eliminate inefficiencies, leading to improved project timelines and resource allocation Contributes to department projects ; takes ownership of team projects, driving their execution and coordinating with others effectively. Recommends improvements at team level. Applies a large set of skills and knowledge effectively. Able to tailor consensual verbal and written communications that resonate with different stakeholders. Leverages network and engages independently with colleagues to achieve team goals. Shares best practices with others. Articulates and compares alternative approaches to tasks. Required education Bachelor's Degree Preferred education Bachelor's Degree Required technical and professional expertise Minimum 4 to 5 years of experience in developing automation using Python. Hands-on developing PyTest fixtures. Good exposure to writing test plans, test cases and test reports compilation Good understanding of Github, Jenkins, Jira, Test management system Good understanding of Linux, Openshift Container Platform, Kubernetes, Openshift virtualization Good exposure to VMWare, Storage concepts like virtualization, backup and restore. Excellet problem solving and troubleshooting skills Good written and oral communication skills Preferred technical and professional experience EditViewInsertFormatToolsHelp

As a QA (Quality Assurance) /Test Developer you will be designing better ways to identify potential weak spots, inefficiencies, and issues within software systems. This position will work closely with development teams and other test engineers in the implementation and delivery of software products that meet rigorous quality standards, budgets, and timelines. You will play a key role by delivering quality functions for development teams within test driven framework. Your scope will include Test Plan Development, Test Case Execution, Automation Testing, Data Creation, API Validation and incorporating test automation in the CI/CD pipelines. Your primary responsibilities include: Selenium Test Automation Proficiency: Have experience with Selenium test automation. JAVA Proficiency: Possess knowledge with JAVA programming language. API Testing and Automation Familiarity: Hands-on experience in API testing and API automation. Agile Development Methodologies: Familiarity with agile development methodologies. Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise 5+ years of experience. Test Planning and ExecutionDevelop comprehensive test plans and execute test cases to ensure software products meet quality standards and requirements. Automation IntegrationImplement and integrate test automation into Continuous Integration/Continuous Delivery (CI/CD) pipelines to streamline testing processes and enhance efficiency. Collaborative DevelopmentWork closely with development teams to identify potential weak spots, inefficiencies, and issues within software systems, fostering a collaborative approach to software quality. Quality AssuranceDeliver quality functions for development teams, supporting test-driven development frameworks and ensuring rigorous quality standards are met throughout the software development lifecycle. Excellent Problem-Solving Skills: Demonstrated experience in problem-solving, with the ability to tackle complex issues and find effective solutions. Preferred technical and professional experience Automation FrameworksProficiency with API testing and API automation in other Automation frameworks, such as Playwright etc. Cloud/Container skillsFamiliarity with cloud and container technologies, including Docker, Kubernetes, Red Hat OpenShift, etc. Programming LanguagesJavaScript, Jenkins, Linux, and Unix environments.

Job Description Labware 7. LIMS implementation, Master data creation, Validation. Caluculation configurations. CSV documentations, Test Script review, Instrument integrations. LIMS trouble shooting and resolutions. QAMS activities, CCP, CAPA, Deviation investigation. Work Experience 4-7 years of experience in QC and LIMS Implementation Education Post Graduation in Analytical Chemistry or Analytical Chemistry Graduation in Pharmacy or Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

Roles and Responsibilities Conduct quality reviews of documents, including CAPAs, change controls, and 21 CFR compliance. Ensure adherence to company policies and procedures through document review. Develop and maintain a thorough understanding of regulatory requirements for pharmaceuticals. Provide feedback on document quality and suggest improvements where necessary. Collaborate with cross-functional teams to resolve issues related to document control.

Role & responsibilities 1. Ensure compliance with cGMP, safety, and statutory requirements in warehouse operations. 2. Manage receipt, inspection, storage, sampling, issuance (FIFO), and dispatch of materials. 3. Maintain and review SOPs, GMP records, bin cards, and warehouse documentation (eDMS). 4. Oversee training, task allocation, and performance monitoring of warehouse personnel. 5. Monitor equipment calibration, housekeeping, preventive maintenance, and validations. 6. Track inventory status including non-moving, rejected, and re-test materials. 7. Handle deviations, change controls, CAPA, and risk mitigation activities. 8. Coordinate with QA, QC, R&D, HR, and Engineering to ensure smooth warehouse functioning. Desired Candidate Profile Strong understanding of SAP systems and ability to work on them effectively. Excellent communication skills for effective collaboration with team members.

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and fixtures for development and manufacturing Subject matter expert in the material properties of thermoplastic polymers and balloon forming processes to ensure optimized design inputs and outputs Support development of equipment, process, and measurement strategy as related to Balloons Plans, organizes, and manages related projects and staff as appropriate Train, mentor, and provide direction to Operators and Technicians. Support sustainable operations as a subject matter expert Design and integrate related test methods Understand customers applications and design products to meet application demands Lead the development of balloon forming equipment, process, and measurement strategy Directly review and validate the measurement results of development balloon runs Collaborate across operations and engineering teams to build consensus, summarize data to drive progress, to draws conclusions, and to create recommendations Qualifications Bachelor s Degree in Chemical, Mechanical, Material Science, or other related fields. A minimum of 5 years of industry experience in a manufacturing environment Extrusion/Injection molding/related experience preferred Innovative idea-generator who enjoys leading teams and mentoring others Problem-solving mindset backed up by solid statistical analysis skills Self-starter, self-motivator with the ability to work effectively in a team environment 1+ years of experience of indirectly providing direction to support technicians is preferred IQ/OQ/PQ experience a plus Six Sigma, lean certification a plus SAP experience a plus Competencies Location