2369 Qms Jobs - Page 9

Let s do this. Let s change the world. In this vital role you will be part of the Global Patient Safety organization this team implements Intake and Triage of product complaints (PCs), adverse events (AEs) and other safety findings (OSFs). Their focus includes assuring compliant processes and systems remain fully compliant through the pharmacovigilance and quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Job Summary The PC Triage and Intake Associate is responsible for global triage of Product Complaints and ensure proper Adverse Events and/or Other Safety Findings were captured. Ensure to capture the patient outcome because of the reported event. This position ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes, and procedures. Key Activities Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes. Triage of initial data entry (book-in) of new PC, AE and OSF cases is complete. Performs the initial book-in activities and appends additional information or documents to the case as they are received in the global intake system. Ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes and procedures. Supports performance emphasized culture. Ensures quality of PC, AE and OSF records. Implements Standard Operating Procedure requirements for the triage process. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Education & Experience (Basic) Master s degree and 3 years of Drug Safety or Life Sciences experience OR Bachelor s degree and 5 years of Drug Safety or Life Sciences experience Education & Experience (Preferred) Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry Bachelor s Degree in a health-care subject area or scientific field Previous experience with a corporate intake system or safety database Ability to successfully manage workload to strict timelines Familiarity with basic project management tools Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support. Job Summary: Accountable for quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases. Ensure Vendors deliver high quality device/combination product cases through metric management and meet all worldwide regulatory authority requirements. Provide vendors with resources and training to perform their role. Responsible for raise of device/combination product case related issues. Providing audit/inspection support for case management related activities including liaising with vendors to provide support as applicable for device/combination products. Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness. May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable. Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor. Key Activities: Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes. Ensures compliance and timely reporting with device/combination product cases through query process. Contributes to the implementation of new intake-related systems, processes and procedures within the process. Supports an engaging culture. Ensures quality of PC, AE and OSF records. Applies analytical skills to evaluate moderately complex situations using multiple sources of information while applying multiple systems. Implements Standard Operating Procedure requirements for device/combination product cases. Develops solutions to technical problems up to moderate complexity. Knowledge and Skills: Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices). Familiarity with clinical development process. Demonstrating high case level productivity and quality. Attention to detail. Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 4 years of Drug Safety or Life Sciences experience OR Master s degree and 7 years of Drug Safety or Life Sciences experience OR Bachelor s degree and 9 years of Drug Safety or Life Sciences experience. Education & Experience (Preferred): Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry. Bachelor s Degree in a health-care subject area or scientific field. Previous experience with a corporate intake system or safety database. Ability to successfully manage workload to strict timelines. Familiarity with basic project management tools. Demonstrated ability to consistently deliver on-time, and high-quality results. Ability to operate in a matrixed or team environment. Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices). What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Position Title: QMS Manager – Plastic Injection Moulding Department: Quality Assurance / Quality Management Reporting To: Plant Head Exp. - 10-15 Years Job Location - Chandigarh and Baddi Interested candidates share resume on 9815675900

Manage Change Notices in Windchill PLM, handle QMS docs and CAD files, process ECNs/ECRs, ensure ISO 13485 compliance, support QMS improvements, and collaborate globally for timely and accurate documentation Required Candidate profile This is for quality management document control.

Role & responsibilities Quality policies and programs : Develops, implements, monitors, maintains and improves the quality policies and the quality Manual, in coordination with the HOD & Handle the Production Process, Incoming Quality and leading the QMS for the entire organization, according to the global standard, in order to ensure an adequate quality assurance system by which the certificates are retained. Prepares improvements to the quality policy, tracks developments on quality and includes these in the policy, in accordance with internal and external standards and divisional / group QA policies. Quality Systems / certificates and continuous improvement : Establishes and maintains the quality management system in which all procedures and process descriptions are defined according to the requirements of the relevant standards and schemes within the organization so that understanding the processes and division of responsibilities arises and continuous quality can be guaranteed and the relevant certificates are retained. Drives continuous improvement processes in the organization, promoting and supporting the team members and improve the processes with HOD guidelines. Conducts risk-based assessments / improvement programs to minimize impact of any process and product deficiencies Liaises with relevant departments, collects data, relevant for the quality systems, from departments and ensures that all data included in the quality systems are up-to-date Quality Control : Drafts and ensures compliance with the procedures for the implementation of quality control of incoming and manufactured goods and in-process controls, in accordance with the organization guidelines and relevant standards and schemes. Similarly, with regard to the procedures for the processing of products that do not meet the specification, in order to ensure that the products meet the required quality with minimization of costs. Communication : Promotes all aspects of Quality Assurance with all relevant departments, supports the communication of quality programs and standards to the organization, and may coordinate training in relevant areas. Organizes local Quality Assurance boards and / or participates in internal or external QA bodies Participates in crisis situations (contaminations, severe product defects, etc.) in the relevant crisis teams in order to mitigate / control adverse effects for the organization and / or conduct root cause analyses to prevent incidents recurring Complaints handling : Ensures the treatment and (root cause) analysis of product complaints, so that corrective and preventive measures can be initiated. Analysis the complaints of based on the customer support feedback and close with defined lead time with out recurrence. Audits Organizes and guides internal and external audits, according to the guidelines of quality systems, so that the quality procedures are complied with, with the aim of maintaining the quality certificates. Executes internal audits as well as external audits, in coordination and consultation with external auditors. Reports the outcome of audits to the relevant stakeholders, monitors any follow-up actions Preferred candidate profile : Experience in Supplier Quality Management, Incoming Goods Inspection (covering Electronics, Mechanical, PCB, Cables, Standard and Custom parts) Experience in Mass Production Quality activities. Good working knowledge of ISO9001, ISO14001, and ISO 18000 certifications Good knowledge of 5S, Kaizen, SPC, Lean & Six Sigma techniques. Good knowledge of Control plans and FMEA. Purpose of the Job: Responsible for the development, implementation and monitoring of all internal Quality Assurance plans and programs necessary for the relevant markets Nutreco serves, contributing to the realisation of organisations goals and objectives. This is achieved by safeguarding the desired internal and external quality levels of products and processes and services and retaining all relevant certificates required in order to meet global and local standards and schemes. Quality management is focused not only on product/service quality, but also on the means to achieve it. Quality management therefore uses quality assurance and quality control of processes as well as products to achieve a more consistent quality. He / She direct an entitys inspection and testing programs, as well as its proactive quality assurance procedures designed to prevent defects and / or improve performance. In pursuing these objectives, he / she manages the department's employees and interacts with other managers and staff in departments that run processes where quality is an important dimension with external & Internal Parties. (e.g. production, research, supply chain, Vendor etc.).

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Gurgaon, Haryana, India Job Description: Required Qualification and Core Competencies for the role: 8-12 years of experience in regulatory affairs in medical device industry. Strong knowledge of Medical Device Rule 2017 Strong knowledge of Drugs and Cosmetics Act Knowledge in the international regulations of Medical Devices in US and EU Sound knowledge on Medical Device Quality Management System ISO 13485 Excellent proficiency with software tools Key responsibilities: Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer). Draft, review and submission of other Regulatory submissions (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India and IB market in accordance with applicable regulations and relevant guidelines. Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise Update and live maintenance of business plan in SharePoint for assigned franchises/ licenses. Assist in the preparation of technical presentations/ meetings with regulator Ensures compliance with regulatory agency regulations and interpretations. Gathers and assembles information, prepares documents for New Product Applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations (Lifecycle management) Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/ franchises. Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / Admin assistant and work as per the applicable SOPs and guidelines. Maintenance of RA database for the responsible franchises in MDRIM tool. Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/other portals. Ensuring timely completion of assigned Quality issues/ Corrective Actions in ETS system. Creation and maintenance of Product Registrations request Form (PRRF) for any registration activities under responsible franchises/ licenses and Change Controls for any product discontinuation/ changes as per defined procedure. Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/ other portal. Ensure on time archival of regulatory submission documents. Supporting Pharmacovigilance and artwork activities for biological products (if applicable) Control of regulated/ non-regulated products/ codes in RA gateway tool. Support with on-time inputs for monthly regulatory report. Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware. Conducting Regulatory Standard Management monthly meeting and keeping a track on action items identified.

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits

Responsibilities: * Conduct quality control activities * Ensure compliance with AS9100D standards * Perform drawing QC checks * Inspection Techniques: Variable & Dimensional * Ensuring measuring instruments Calibration * Good Knowledge of GD&T Free meal Office cab/shuttle Health insurance Accidental insurance Maternity policy Gratuity Provident fund

Associate Process Manager Roles and responsibilities: Create effective Powerpoint presentations Be able to lead present in client discussions on Projects Drive process excellence across assigned projects Lead and mentor projects from ideation to implementation, leveraging solutions ranging from Excel to machine learning. Champion continuous improvement through Kaizen events. Communicate effectively with senior stakeholders, providing regular project updates. Conduct process audits and implement risk management strategies. Technical and Functional Skills: Bachelors Degree with 3+ years of experience in understanding & implementation of LEAN Six Sigma methodologies like DMAIC, DMADV (Six sigma green belt certified) Excellent Communication & Presentation Skills (written & verbal) Excellent with creating Powerpoint presentations Understanding of risk management and quality tools (FMEA, Fishbone, 7 QC Tools, MP tools) Strong interpersonal skills and a collaborative mindset Proficiency in Microsoft Excel.

Associate Process Manager Roles and responsibilities: Create effective Powerpoint presentations Be able to lead present in client discussions on Projects Drive process excellence across assigned projects Lead and mentor projects from ideation to implementation, leveraging solutions ranging from Excel to machine learning. Champion continuous improvement through Kaizen events. Communicate effectively with senior stakeholders, providing regular project updates. Conduct process audits and implement risk management strategies. Technical and Functional Skills: Bachelors Degree with 3+ years of experience in understanding & implementation of LEAN Six Sigma methodologies like DMAIC, DMADV (Six sigma green belt certified) Excellent Communication & Presentation Skills (written & verbal) Excellent with creating Powerpoint presentations Understanding of risk management and quality tools (FMEA, Fishbone, 7 QC Tools, MP tools) Strong interpersonal skills and a collaborative mindset Proficiency in Microsoft Excel.

Associate Process Manager Roles and responsibilities: Create effective Powerpoint presentations Be able to lead present in client discussions on Projects Drive process excellence across assigned projects Lead and mentor projects from ideation to implementation, leveraging solutions ranging from Excel to machine learning. Champion continuous improvement through Kaizen events. Communicate effectively with senior stakeholders, providing regular project updates. Conduct process audits and implement risk management strategies. Technical and Functional Skills: Bachelors Degree with 3+ years of experience in understanding & implementation of LEAN Six Sigma methodologies like DMAIC, DMADV (Six sigma green belt certified) Excellent Communication & Presentation Skills (written & verbal) Excellent with creating Powerpoint presentations Understanding of risk management and quality tools (FMEA, Fishbone, 7 QC Tools, MP tools) Strong interpersonal skills and a collaborative mindset Proficiency in Microsoft Excel.

Associate Process Manager Roles and responsibilities: Create effective Powerpoint presentations Be able to lead present in client discussions on Projects Drive process excellence across assigned projects Lead and mentor projects from ideation to implementation, leveraging solutions ranging from Excel to machine learning. Champion continuous improvement through Kaizen events. Communicate effectively with senior stakeholders, providing regular project updates. Conduct process audits and implement risk management strategies. Technical and Functional Skills: Bachelors Degree with 3+ years of experience in understanding & implementation of LEAN Six Sigma methodologies like DMAIC, DMADV (Six sigma green belt certified) Excellent Communication & Presentation Skills (written & verbal) Excellent with creating Powerpoint presentations Understanding of risk management and quality tools (FMEA, Fishbone, 7 QC Tools, MP tools) Strong interpersonal skills and a collaborative mindset Proficiency in Microsoft Excel.

Associate Process Manager Roles and responsibilities: Create effective Powerpoint presentations Be able to lead present in client discussions on Projects Drive process excellence across assigned projects Lead and mentor projects from ideation to implementation, leveraging solutions ranging from Excel to machine learning. Champion continuous improvement through Kaizen events. Communicate effectively with senior stakeholders, providing regular project updates. Conduct process audits and implement risk management strategies. Technical and Functional Skills: Bachelors Degree with 3+ years of experience in understanding & implementation of LEAN Six Sigma methodologies like DMAIC, DMADV (Six sigma green belt certified) Excellent Communication & Presentation Skills (written & verbal) Excellent with creating Powerpoint presentations Understanding of risk management and quality tools (FMEA, Fishbone, 7 QC Tools, MP tools) Strong interpersonal skills and a collaborative mindset Proficiency in Microsoft Excel.

Associate Process Manager Roles and responsibilities: Create effective Powerpoint presentations Be able to lead present in client discussions on Projects Drive process excellence across assigned projects Lead and mentor projects from ideation to implementation, leveraging solutions ranging from Excel to machine learning. Champion continuous improvement through Kaizen events. Communicate effectively with senior stakeholders, providing regular project updates. Conduct process audits and implement risk management strategies. Technical and Functional Skills: Bachelors Degree with 3+ years of experience in understanding & implementation of LEAN Six Sigma methodologies like DMAIC, DMADV (Six sigma green belt certified) Excellent Communication & Presentation Skills (written & verbal) Excellent with creating Powerpoint presentations Understanding of risk management and quality tools (FMEA, Fishbone, 7 QC Tools, MP tools) Strong interpersonal skills and a collaborative mindset Proficiency in Microsoft Excel.

We are looking for a skilled E-commerce Operations Manager to join our team at CSTE International, with 3-8 years of experience in the IT Services & Consulting industry. Roles and Responsibility Manage and oversee e-commerce operations for smooth and efficient functioning. Develop and implement strategies to enhance customer satisfaction and loyalty. Collaborate with cross-functional teams to achieve business objectives. Analyze market trends and competitor activity to identify growth opportunities. Ensure compliance with regulatory requirements and industry standards. Lead and motivate a team to achieve operational excellence. Job Requirements Proven experience in e-commerce operations management or a related field. Strong understanding of IT Services & Consulting principles and practices. Excellent leadership and communication skills. Ability to analyze data and make informed decisions. Strong problem-solving and strategic thinking skills. Experience with e-commerce platforms and technologies.

1. Assist in managing and maintaining the Quality Management System (QMS) as per ISO 9001 2. Assist in internal and external audits, including customer and certification audits. 3. Provide training and guidance to junior quality staff and shop floor operators. 4. Coordinate with the Production department to define CTQs (Critical to Quality) and develop Quality Control Plans (QCPs). 5. Interact with customers to understand quality concerns and implement appropriate corrective measures. 6. Halt production in case of identified non-conformities to prevent further defects. 7. Conduct root cause analysis and prepare corrective and preventive action plans (CAPA). 8. Manage and maintain all ISO documentation, audits, and ensure system sustenance. 9. Create and track non-conformity reports (NCRs) related to suppliers and follow up for closures. 10. Prepare and update quality instruction sheets for incoming material inspection. 11. Use and apply quality tools such as 7 QC tools for problem solving and process improvements. 12. Promote awareness and compliance of ISO standards and EHS (Environment, Health, Safety) practices across the team. 13. Lead and guide the quality team to maintain product quality and achieve quality goals. Apply on the link below- https://app.hrone.cloud/apply-job?appId=3Sh0-h-nzgT4FXh-rRZExE_yFiu3JlBUAskvgpsnbrKUaVgOiIg2r38rZBDW04iy3hdfphBJT9t463ojGYvum3ytw_X72qlfeCf4ogwZKltJzx3AqXGmyujducWqSW1T&dc=adept&rqt=UVozgs-AUV1ILPLBxDlf7A&cc=P59JVbpbHWXmZ_sFzZ_bYA&pid=S8MAvGkBFqb_YPN4dpEQzA&dptc=r0_XPJmvFT_oCLGRN8jpfg&st=-n_C2-YChNaZnubp3_OPew&fm=CR&headerColor=%23807e80&fontSize=10&buttonColor=%2300bfa5

Pre-preparation for Customer Key Handover as per SOP. Generate rapport with the customers coming for Key Handover Demonstrate a high degree of warmth while dealing with / talking to the customers Register all customer feedback/concerns and channelize it as per SOP in order to close the loop. Maintain Customer data confidentiality. Any other activity associated with Customer Engagements/ Events - assist in these

Job_Description":" Hiring Experienced Surgery Trainers @ Chennai Minimum 1+ years of experience as Medical Coding Trainer or 5+ years of experience in Medical Coding with atleast 2 years in Auditing Any AAPC/AHIMA Certification (Mandatory) Medical Insurance for self and family Complementary Food, Snacks and Beverage Annual Salary Hikes and Recognition WFO - Chennai & Hyderabad ","

ManekTech is looking for QC Engineer to join our dynamic team and embark on a rewarding career journey Develop and implement quality control plans, procedures, and documentation based on industry standards and customer requirements Perform inspections and tests on raw materials, components, and finished products to ensure compliance with quality standards Conduct root cause analysis to identify and resolve quality issues, and implement corrective and preventive actions Collect and analyze quality data, generate reports, and provide recommendations for process improvements Collaborate with production, engineering, and other departments to resolve quality-related problems and implement quality improvement initiatives Train and educate staff on quality control procedures and best practices Monitor and audit production processes to ensure adherence to quality standards and specifications Participate in supplier evaluations and audits to ensure the quality of purchased materials and components Stay updated with industry standards, regulations, and advancements in quality control practices Participate in quality management system (QMS) activities, including internal audits and compliance assessments Qualifications:Bachelor's degree in engineering or a related field Previous experience in quality control, quality assurance, or a similar role Solid understanding of quality management principles, methodologies, and tools Proficient in using quality control equipment, measurement instruments, and software applications Strong analytical and problem-solving skills with attention to detail Excellent written and verbal communication skills Ability to work collaboratively in cross-functional teams Knowledge of relevant industry standards and regulations Experience with ISO or other quality management systems is a plus Certifications in quality control or quality management (g, Six Sigma, ASQ) are desirable

Lodha Group is looking for Data Analyst (Pre-Sales) to join our dynamic team and embark on a rewarding career journey Managing master data, including creation, updates, and deletion. Managing users and user roles. Provide quality assurance of imported data, working with quality assurance analysts if necessary. Commissioning and decommissioning of data sets. Processing confidential data and information according to guidelines. Helping develop reports and analysis. Managing and designing the reporting environment, including data sources, security, and metadata. Supporting the data warehouse in identifying and revising reporting requirements. Supporting initiatives for data integrity and normalization. Assessing tests and implementing new or upgraded software and assisting with strategic decisions on new systems. Generating reports from single or multiple systems. Troubleshooting the reporting database environment and reports. Evaluating changes and updates to source production systems. Training end-users on new reports and dashboards. Providing technical expertise in data storage structures, data mining, and data cleansing.

Job Summary: We are looking for an experienced professional to manage and validate GxP computerized systems in a regulated pharmaceutical environment. The ideal candidate will play a key role in ensuring IT compliance with industry regulations and supporting core Quality Management System activities. Key Responsibilities: Installation and configuration of operating systems and other applications Diagnosing and troubleshooting of computer system and software problems Maintain an inventory of GxP computerized systems. Preparation and implementation of all the IT procedures as per GMP requirements. Responsible for Electronic data backup, archival and restoration. Verification of daily backup for electronic data generated for instruments. User management (Creation / modification of User IDs and passwords, assigning privileges) for laboratory and GMP Softwares. Developing the validation deliverables for computerized systems used in GLP, GMP and GCP environments. (Manufacturing and Laboratory Systems) Preparation, execution and reporting of GxP computerized systems validation deliverables Maintain the validated state of all GxP computerized systems Conduct periodic reviews of all GxP computerized systems to ensure continued compliance. Manage QMS activities to ensure timely completion of action items, including Change Controls, Deviations, investigations, and CAPAs. Review protocols, QMS documents, CSV deliverables, and other related documents to ensure accuracy and compliance. Good knowledge of GMP, 21 CFR Part 11, Annex 11, GAMP 5, Data Integrity requirements for Pharma Required Skills & Experience: 3-4 years in Pharma industry Strong working knowledge of GMP, 21 CFR Part 11, Annex 11, and GAMP 5 Hands-on experience in validation of GxP systems within a pharma or life sciences setup Solid understanding of pharmaceutical regulatory and compliance frameworks Educational Qualification: M.Sc / B.E / B.Tech / MCA (with relevant industry experience)

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for effective review and approval of Laboratory investigation reports / Deviations / Corrective and preventive actions (CAPA s)/ change controls/ method transfer/ validation protocols and reports in a timely and compliant manner. Job Responsibilities Review and approval of lab investigation reports , Deviations, Corrective action and preventive actions (CAPA s) and Temporary change controls. Provide guidance on technical assessment/ investigations to team members and stake holders to ensure compliance. Review of standard operating procedures. Assessment and approval of change controls. Review and approval of instrument qualification and calibtration documents in timely manner. Review and approval of method transfer and validation protocols/ reports. Review and approval of specifications and MOA. Provide support to self inspections and audits by regulatory authorities / third parties as required. Responsible and accountable for managing subordinates and to provide all required training requirements, tools and follow procedures in accordance with applicable regulatory and other pertinent requirements. Provide training as required. Recruit, train, develop and manage effectively the ongoing performance of the direct reports, which includes but not limited to: Reviewing and updating team developing plans, ensuring that all the team members are properly trained and qualified to execute their duties. Providing coaching, feedback and recognition. Perform all work in support of our corporate values of collaboration,courage, perseverance and passion. Demonstrates strong and visible support of values. Communicate corporate vision and goals to direct reports in an effective and efficient manner. All other duties as assigned. Job Requirements Education Minimum Bachelor of Pharmacy / Science or any equivalent degree. Knowledge, Skills and Abilities Possess sound knowledge in quality management system which comprises of change controls, deviations and LIR s Hands on experience in Trackwise application, LIMS and Empower application. Maintains good interpersonal skills and communication skills. Knowledge on method transfer and validation activities. Experience Minimum 8-12 years of experience in GMP regulated pharmaceutical industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

We are looking forward for Veeva QMS 3 4-year experience resources who also work on Vault QMS side. We do L2/L3 ( Incident/Service request ) etc in 24 x 7 shift operations share profiles of available resources.

Associate Process Manager Roles and responsibilities: Create effective Powerpoint presentations Be able to lead present in client discussions on Projects Drive process excellence across assigned projects Lead and mentor projects from ideation to implementation, leveraging solutions ranging from Excel to machine learning. Champion continuous improvement through Kaizen events. Communicate effectively with senior stakeholders, providing regular project updates. Conduct process audits and implement risk management strategies. Technical and Functional Skills: Bachelors Degree with 3+ years of experience in understanding & implementation of LEAN Six Sigma methodologies like DMAIC, DMADV (Six sigma green belt certified) Excellent Communication & Presentation Skills (written & verbal) Excellent with creating Powerpoint presentations Understanding of risk management and quality tools (FMEA, Fishbone, 7 QC Tools, MP tools) Strong interpersonal skills and a collaborative mindset Proficiency in Microsoft Excel

Associate Process Manager Roles and responsibilities: Create effective Powerpoint presentations Be able to lead present in client discussions on Projects Drive process excellence across assigned projects Lead and mentor projects from ideation to implementation, leveraging solutions ranging from Excel to machine learning. Champion continuous improvement through Kaizen events. Communicate effectively with senior stakeholders, providing regular project updates. Conduct process audits and implement risk management strategies. Technical and Functional Skills: Bachelors Degree with 3+ years of experience in understanding & implementation of LEAN Six Sigma methodologies like DMAIC, DMADV (Six sigma green belt certified) Excellent Communication & Presentation Skills (written & verbal) Excellent with creating Powerpoint presentations Understanding of risk management and quality tools (FMEA, Fishbone, 7 QC Tools, MP tools) Strong interpersonal skills and a collaborative mindset Proficiency in Microsoft Excel