2371 Qms Jobs - Page 24

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Institutional_Finance_Buy_Side_Others. Experience: 8-10 Years.

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Required Candidate profile Lead handling of Quality Management System (QMS) activities: deviations, change controls, CAPAs, OOS/OOT, and risk assessments. Immediate to 30 days preferred

Novo Nordisk Global Business Services (GBS) India Department GCM DP RoW Job Location Hyderabad Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global healthNovo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you''ll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). ! The Position As a Manufacturing Specialist (SME), you''ll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top-tier quality with our Contract Manufacturing Organizations (CMO) partners. Your key responsibilities will include: Lead cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMOs) partners as the receiving Unit. Act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards. Provide training, share best practices, and review and approve validation documents to safeguard compliance. Offer oversight and support during the planning and execution of validation and qualification activities. Define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers. Drive problem-solving initiatives and provide scientific and technical solutions within tight project timelines. Qualifications Bachelor’s /Master’s degree in engineering. Possess 10+Years experience and relevant 5 years of manufacturing experience, especially in an international, multicultural environment. Expertise in aseptic manufacturing processes is non-negotiable. Capable of communicating naturally and effectively with stakeholders at all levels with adept at finding solutions and motivating stakeholders to achieve ambitious goals. Possessing a strong mindset, a focus on continuous improvement, and keen attention to detail. Demonstrates the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment. About the Department GCM DP RoW Projects is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity. With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, you’ll join a diverse and dynamic team committed to making a difference.

Novo Nordisk Global Business Services (GBS) India Department: GCM DP RoW Location Hyderabad, India Are you an experienced aseptic manufacturing project manager with a strong technical background and a passion for making a direct impact on patients'' livesDo you thrive in an international environment where cultural awareness is key to your successIf so, this could be your dream role! ApplyNow! The Position As a Project Manager in Aseptic Manufacturing, you will lead and mentor cross-functional teams, including both Novo Nordisk and our Contract Manufacturing Organisation (CMO) partners. It includes, Ensure the seamless Technology Transfer and manufacturing of our commercial products, always upholding Novo Nordisk''s stringent quality standards and adhering to cGMP and regulatory requirements. Lead and manage aseptic manufacturing projects, specifically leveraging your expertise in areas like Formulation/Compounding, Filling, Washing & Sterilisation, Environmental Monitoring, or Clean Utilities. Developing and managing detailed project plans and timelines and communicating effectively with steering groups and key stakeholders. Monitoring progress and proactively securing necessary resources. Developing project risk grids and identifying mitigation strategies with both Novo Nordisk and our Contract Manufacturing Organisation (CMOs). Qualifications Bachelor’s or Master’s degree in engineering. Possess experience of 5-12Years of project management experience with a proven track record of successful project delivery in a highly regulated environment, especially internationally. Aseptic manufacturing experience is a must, and experience with Technology Transfer of biologics is a significant advantage. Professional experience balancing individual drive with effective stakeholder involvement. Proficiency in project management software (e.g., MS Project, Smartsheet, Jira, or equivalent). Demonstrated fluency in written and spoken English is essential. About the Department GCM DP RoW Projects is a dedicated team committed to providing life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department strives to make a meaningful impact on the quality of life for patients living with diabetes and obesity. Our projects are tailored to meet the unique requirements of each country, offering exciting growth opportunities. With a steadfast commitment to innovation and problem-solving, we work to overcome challenges and navigate complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Join us in making a difference.

Ensure compliance with cGMP, ICH, and regulatory guidelines in API manufacturing. Review and approval of master batch manufacturing records (MBMR) and batch packing records (BPR). Conduct in-process checks and ensure batch release activities. Required Candidate profile Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.). Review of analytical documents, stability protocols, validation protocols & reports. Immediate to 30 days preferred

Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identification of Risks and Regulatory breach on cards processes and provide solution to mitigate risks and control reports to minimize process lapses. Monitor and govern if the defined processes are being executed from time to time, including regulatory changes In-depth understanding of KYC and Other Regulatory Guidelines. Providing tailor made solution to Product Operations for specific business requirement. Ideate & suggest Product and Operations with end to end execution of a Process Digital Journey"s new initiatives features etc. Ensuring the Digital Journey controls and logics is in line with defined Process, Regulation and Risk perspective Responsible for the documentation of Business Processes, workflows. Publish MIS and Reports Job Requirement Graduate/Post-Graduate with at least 5 to 6 years of experience in Business Processes In-depth knowledge of Credit Cards business Knowledge of Regulatory requirements and market competition/intelligence will be an added advantage. Excellent communication skills Verbal & Written Good Logical reasoning and data analysis skill Should be able to think proactively for process changes from Business Process Re-engineering perspective Assertive attitude Self-Driven and ability to follow-up promptly Good analytical skills & eye for details

We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-5 years of experience in the BFSI industry. Roles and Responsibility Conduct risk assessments and evaluations to identify potential threats to the organization. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Analyze market trends and competitor activity to inform business decisions. Identify and report on key performance indicators (KPIs) to senior management. Provide expert guidance on risk management best practices to stakeholders. Job Requirements Strong understanding of risk management principles and practices. Excellent analytical and problem-solving skills with attention to detail. Ability to work effectively in a fast-paced environment with multiple priorities. Strong communication and interpersonal skills, with the ability to build relationships with stakeholders. Experience working with financial data and systems, including risk management software. Strong knowledge of regulatory requirements and industry standards related to risk management.

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Institutional_Finance_Buy_Side_Others Experience: 3-5 Years

Role Purpose The purpose of this role is to ensure compliance and quality of the process within an account. Do Track and review the process quality through audits Develop audit plan as per SOP and allocate reviews to the analysts Monitor to ensure that the audits are being conducted as per plan Review the audit data across the account to review the account performance on quality parameters, identify the error trends Prepare reports for review for the internal leadership as well as client Identify the best practices and work with the delivery team to deploy for improvement Ensure compliance part of the process by front-ending with the external auditors CMMIE or any onsite audits, coordinating with the internal teams and working with SDH and AH to develop SOPs and compliance registers as required for the audits. Drive training within the account to ensure process quality is maintained Conduct Root Cause Analysis of the errors to identify the training intervention to bridge the gap conduct monthly trainings based on the error types identified in the process audits Deploy various training methods (classroom based, web based etc) to develop the skill and reduce error rates Develop the training reports and share with the key stakeholders including the client twice a week. Support the incoming new process For an existing client, support the any new process addition by ensuring online process training is conducted for the agents, agents have the necessary skill and access is granted to them on applications required For any new process outside the account, support the team in identifying the skill, availability of skill within DOP or avenues for upskilling the team to support the new process Effective Team Management Resourcing Hire adequate and right resources for the team Talent Management Ensure adequate onboarding and training for the team members to enhance capability & effectiveness Build an internal talent pool and ensure their career progression within the organization Manage team attrition Drive diversity in leadership positions Performance Management Set goals for the team, conduct timely performance reviews and provide constructive feedback to own direct reports Ensure that the Performance Nxt is followed for the entire team Employee Satisfaction and Engagement Lead and drive engagement initiatives for the team Track team satisfaction scores and identify initiatives to build engagement within the team Mandatory Skills: Technical Consulting Experience: 8-10 Years

Role Purpose The purpose of this role is to ensure compliance and quality of the process within an account. Do Track and review the process quality through audits Develop audit plan as per SOP and allocate reviews to the analysts Monitor to ensure that the audits are being conducted as per plan Review the audit data across the account to review the account performance on quality parameters, identify the error trends Prepare reports for review for the internal leadership as well as client Identify the best practices and work with the delivery team to deploy for improvement Ensure compliance part of the process by front-ending with the external auditors CMMIE or any onsite audits, coordinating with the internal teams and working with SDH and AH to develop SOPs and compliance registers as required for the audits. Drive training within the account to ensure process quality is maintained Conduct Root Cause Analysis of the errors to identify the training intervention to bridge the gap conduct monthly trainings based on the error types identified in the process audits Deploy various training methods (classroom based, web based etc) to develop the skill and reduce error rates Develop the training reports and share with the key stakeholders including the client twice a week. Support the incoming new process For an existing client, support the any new process addition by ensuring online process training is conducted for the agents, agents have the necessary skill and access is granted to them on applications required For any new process outside the account, support the team in identifying the skill, availability of skill within DOP or avenues for upskilling the team to support the new process Effective Team Management Resourcing Hire adequate and right resources for the team Talent Management Ensure adequate onboarding and training for the team members to enhance capability & effectiveness Build an internal talent pool and ensure their career progression within the organization Manage team attrition Drive diversity in leadership positions Performance Management Set goals for the team, conduct timely performance reviews and provide constructive feedback to own direct reports Ensure that the Performance Nxt is followed for the entire team Employee Satisfaction and Engagement Lead and drive engagement initiatives for the team Track team satisfaction scores and identify initiatives to build engagement within the team Mandatory Skills: Quality Assurance Experience: 5-8 Years

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Institutional_Finance_Buy_Side_Others Experience: 8-10 Years

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Institutional_Finance_Buy_Side_Others Experience: 5-8 Years

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Digital Marketing Experience: 1-3 Years

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Retail Banking (CLM) Experience: 1-3 Years

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Training (Ops) Experience: 1-3 Years

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Retail Banking(Card Operations) Experience: 1-3 Years

Responsibilities: *HPLC, ELISA , colorimetry & spectrophotometry, *Protein estimation, Biological assays * Electrophoresis techniques, Anticomplementary activity, *Fc function, Factor IX assay, Thrombin assay, * QMS elements

Perform line clearance activities prior to production operations. Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and Batch Filling Records (BFR). Execute in-process QA checks and verifications during manufacturing and packaging. Manage control sample collection, storage, and documentation. Collect in-process, finished product, and customer complaint samples as required. Compile Annual Product Quality Review (APQR) data and perform trend analysis. Participate in process validation, hold time studies, and related quality activities. Coordinate with relevant departments for timely batch release. Conduct routine GMP checks in production, warehouse, and other relevant departments. Coordinate and review vendor management documents and compile vendor assessment reports. Manage document archival as and when required in compliance with applicable procedures. Issue and control formats, Standard Operating Procedures (SOPs), specifications, and batch records. Qualifications: B.Pharma/M.Pharma/M.Sc (Chemistry) Exp.- 5-10yrs

The Deputy Manager - Quality Management System (QMS) is responsible for overseeing and ensuring the effective implementation, maintenance, and improvement of the Quality Management System within the PCC Digwal. The role involves meticulous management of documentation, adherence to regulatory requirements, and proactive involvement in quality-related processes. Key Responsibilities: Key Responsibilities: 1. Manage the ENSUR system for issuance and retrieval of SOPs, specifications, ATRA, worksheets, stability protocols, BMRs, BPRs, BFRs, etc., as per requirements. 2. Ensure adherence to document control procedures, including archival, retention, and destruction of documents as defined in the procedure. 3. Manage master and obsolete copies of SOPs, specifications, ATRs, worksheets, stability protocols, BMRs, BFRs, BPRs, etc. 4. Track SOPs, procedures, specifications, etc., for revision according to their validity period. 5. Responsible for archival management, including archival and retrieval of documents as required. 6. Perform login and review of quality management system documents such as change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc. 7. Track all quality management system documents till closure, including change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc. 8. Generate monthly tracking reports for quality management systems as per defined procedures. 9. Handle product quality complaints (Adverse Events) and medical inquiry reconciliation tracker for the Digwal site, coordinating with Pharmacovigilance team for adverse events as applicable. 10. Review and approve investigation reports, risk assessment reports, and ensure the implementation and effectiveness assessment of CAPAs. 11. Review quality system documents such as protocols, reports, procedures, APOR, trend analysis reports, continual process verification reports, etc., as required. 12. Share documents with the Regulatory Affairs department for filing updates based on change control implementation. 13. Prepare and review customer and external audit compliance reports. 14. Review and approve analytical reports such as batch analysis, standards, stability studies, etc. 15. Perform GMP verification and compliance review. 16. Ensure compliance with Safety, Health, and Environment (SHE) guidelines, rules, and regulations, including the usage of Personal Protective Equipment (PPE) where applicable. Qualifications: Bachelors degree in pharmacy, Chemistry, or related field. Master's degree preferred. 8-12 years of relevant experience in pharmaceutical Quality Assurance/QMS roles( API / API & Formulations ) Strong understanding of regulatory requirements and quality standards in the pharmaceutical industry. Excellent organizational, communication, and problem-solving skills. Ability to work effectively in a team and independently, with attention to detail and accuracy Skills: Proficiency in handling documentation and data management systems, particularly Harmony. Strong organizational skills with attention to detail and the ability to manage multiple priorities.

Handling QMS with audit compliance, Preparation of SOP, Protocol, Reports & Formats Preparation of PMS & check list of Equipment & utilities. Facility Qualification, Protocol & Report of filter cleaning records of AHU,LAF/RLAF, Dust collector

The ideal candidate should have a good understanding of cGMP. You should be capable of independently managing the Receipt, Issue & Dispatch activities related to Raw Materials (RM), Packaging Materials (PM), and Finished Goods (FG). Additionally, familiarity with Quality Management Systems (QMS) and Safety protocols is essential for this role.,

Overview of the role: Alvotech is currently seeking a Quality Control scientist in the Microbiology Lab to join our Microbiology team in Reykjavik. QC Microbiology scientist is responsible for various microbiological testing, ensuring that the testing related to microbial analysis are conducted accurately, efficiently, and in compliance with regulatory standards, particularly Good Manufacturing Practices (GMP) to support manufacturing operations and shows thorough understanding of various techniques and microbial processes. Scope and responsibility: Performs routine microbial testing with advanced techniques to support manufacturing during 24/7 operations (shift-based work schedule). Execute endotoxin and bioburden testing Plate reading activities Sampling Environmental and Utility monitoring samples Execution of method and product verifications Management of identifications, microbial cultures and maintenance Performing routine cleaning, verification, reviews, stock checks, and upkeep of laboratory and equipment Participate as required in Aseptic Process Simulation Activities Support quality events such as CAPAs, Deviations, Change controls and laboratory investigations. Participation in the creation and maintenance of quality documents within Alvotech. Contributes to other documentation reviews and/or updates within the Quality management system, as Subject matter expect. Job requirements: BSc or M.Sc in Microbiology or relevant scientific discipline 1-5 years of experience in Pharmaceutical or Biopharmaceutical industry and a direct experience in the field of Microbiology. Strong understanding of microbial processes and regulatory compliance Good conceptual, problem solving, and organizational skills - must be detail-oriented, well organized, and able to work independently and in teams Knowledge of Good Manufacturing Practices (GMP) and documentation Rules is an asset. Proficient in using a PC and common Microsoft packages such as Word and Excel. Ability to work on a shift-based pattern work schedule What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be a part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. Support for personal growth and internal career development. Company social events and milestone celebrations. Excellent in-house canteen and coffee house. Exercise and well-being support for full-time employees. On-site shower facility. Transportation grant towards eco-friendly modes of travel for full-time employees. Internet at home for full-time employees. Why Alvotech We at Alvotech are passionate about improving lives by increasing access to affordable biologics. We re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity, and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work, and empowered to succeed in an agile environment. True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds, regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let s create a healthier world together through affordable biologic medicines.

Overview of Role Alvotech is currently seeking a Quality Control senior scientist in the Microbiology Lab to join our Microbiology team in Reykjavik. QC Microbiology senior scientist is responsible for various microbiological testing, ensuring that the testing related to microbial analysis are conducted accurately, efficiently, and in compliance with regulatory standards, particularly Good Manufacturing Practices (GMP) to support manufacturing operations and shows thorough understanding of various techniques and microbial processes. Additionally senior scientist supports variosu projects with new product introduction, laboratory investigations and overall improvement projects within the team. Scope and responsibility Performs routine microbial testing with advanced techniques to support manufacturing during 24/7 operations (shift-based work schedule). Execute endotoxin and bioburden testing Plate reading activities Sampling Environmental and Utility monitoring samples Execution of method and product verifications Management of identifications, microbial cultures and maintenance Performing routine cleaning, verification, reviews, stock checks, and upkeep of laboratory and equipment Aseptic practices Participate as required in Aseptic Process Simulation Activities Support and lead quality events such as CAPAs, Deviations, Change controls and laboratory investigations. Creation of testing protocols and reports Participation and leading in creation and maintenance of quality documents within Alvotech. Training of personele Contributes to other documentation reviews and/or updates within the Quality management system, as Subject matter expect. Job requirements M.Sc in Microbiology and/or other relevant scientific discipline 5+ years of experience in Pharmaceutical or Biopharmaceutical industry and a direct experience in the field of Microbiology. Strong understanding of microbial processes and regulatory compliance Good conceptual, problem solving, and organizational skills - must be detail-oriented, well organized, and able to work independently and in teams Knowledge of Good Manufacturing Practices (GMP) and documentation Rules is an asset. Proficient in using a PC and common Microsoft packages such as Word and Excel. Ability to work on a shift-based pattern work schedule What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be a part of a global and fast-growing company. An international work culture that encourages diversity, collaboration and inclusion. Positive, flexible, and innovative work environment. Support for personal growth and internal career development. Company social events and milestone celebrations. Excellent in-house canteen and coffee house. Exercise and wellbeing support for full-time employees. On-site shower facility. Transportation grant towards eco-friendly modes of travel for full-time employees. Internet at home for full-time employees. Why Alvotech At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment. True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let s create a healthier world together, through affordable biologic medicines.

Understand requirement and inspection level as per EN 10204 Ensure compliance with customer requirements, product specifications, and relevant industry standards (e.g., ISO, BIS, ASME, DIN). Maintain proper records of inspection reports, non-conformities, and corrective actions. Close all punch points on Dossier and seek order clearance Review inspection pre-requisite like Approved QCP , GAD, Scope of inspection Conduct and review various NDT test like UT,PT, RT Shall have knowledge of various material like Cast Iron , Steel, Plastic, fasteners with respective grades and standards. Required Qualifications and Skills: Education - Diploma in Mechanical Engineering / BSc Experience - 5- 6 Years in customer Inspection and Documentation Skills - Strong understanding of engineering drawings, inspection standards, and quality documentation Excellent communication and interpersonal skills to interact with customers Proficiency in MS Office and familiarity with SAP & QMS systems. Ability to handle pressure and manage inspection schedules effectively. NDT L II VT, PT

Be developing functional and automated tests and test harnesses application for application under test. Strategizing and executing End to End System verification Testing Work with the software developers to implement integration and verification automation at all levels of the software stack and system. Authoring and reviewing functional and automated tests and test harnesses application and System under test Review verification results looking for compliance to our quality management system. Be profiling performance/load testing tools, and drive testability and diagnostic ability into the product. Partner with and provide direction to fellow team members to diagnose bugs/defects and formulate solutions Review verification results looking for compliance to our quality management system. Technical Expertise: Strong Experience in BDD, Data driven and Hybrid automation frameworks (preferably cucumber & JBehave) Experience in automation development using Selenium, Squish and Core Java Strong Experience to programmatically test products; measure test coverage; develop best automation, profiling, and performance/load testing tools; and drive testability and diagnostic ability into the product. Basic knowledge of Ubuntu, Linux and Windows OS knowledge Basic knowledge on Network protocols Knowledge of bugs/defects life cycle. Knowledge of HP ALM or equivalent product life cycle management tools Basic Qualifications: Bachelor degree in computer science or in STEMMajors (Science, Technology, Engineering and Math). A minimum of 6-8 years of experience in developing automated tests for products through testing and verification activities. Quality Specific Goals: Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. Complete all planned Quality & Compliance training within the defined deadlines. Work Experience Technical Expertise: Strong Experience in BDD, Data driven and Hybrid automation frameworks (preferably cucumber & JBehave) Experience in automation development using Selenium, Squish and Core Java Strong Experience to programmatically test products; measure test coverage; develop best automation, profiling, and performance/load testing tools; and drive testability and diagnostic ability into the product. Basic knowledge of Ubuntu, Linux and Windows OS knowledge Basic knowledge on Network protocols Knowledge of bugs/defects life cycle. Knowledge of HP ALM or equivalent product life cycle management tools