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9 Job openings at VIATRIS
Officer / Executive - Quality Control

Nashik

1 - 6 years

INR 3.0 - 8.0 Lacs P.A.

Work from Office

Full Time

Role: Officer / Executive - Quality Control Job Location: Nashik At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via: Access Providing high quality trusted medicines regardless of geography or circumstance; Leadership Advancing sustainable operations and innovative solutions to improve patient health; and Partnership Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here's how this role, will make an impact: Role Purpose Seeking for candidates (Male/Female) with sound qualification background to ensure the testing of drug product in Quality control lab and to ensure every product is of the highest quality. They shall be concerned with sampling, specifications, testing, documentation, release procedures which ensure that the necessary and relevant tests are carried out under the norms of cGMP. Role & responsibilities Candidate must have relevant experience in Quality control OSD and QMS and able to operate & maintain laboratory equipment/instruments (HPLC, GC, Malvern Particle sizer, dissolution apparatus etc.) as per procedure. To maintain documents as per GLP requirements. To ensure the calibration status of laboratory equipment & instruments. To report and involve in incidence/Deviation/OOS/OOT investigations. Candidate must have sound exposure in the Quality Control Laboratory to supervise and maintain documents and retention of records as per GMP requirements. To ensure the review of QC documents like analytical reports SOPS, Qualification, Logbooks, Raw data sheet, analytical records, calibration and ensuring compliance to observations with proper root cause and justifications. Candidates participate in initiation, review, and closure of OOS/OOT and monitor the CAPA with implementation in Track wise. To ensure the compliance of the Corrective and Preventive Actions (CAPA) necessitated through various activities such as Regulatory Audits, Market Complaints, and Product Recall & Annual Product Review in the QC if applicable. To support Quality Assurance / Compliance /Regulatory Systems, Processes and ensure Monitoring, Execution, Initiation of the Quality Management Systems in Quality Control laboratory. Qualification & Experience Candidate must be B. Pharm/ M. Pharma/ M. Sc In Chemistry Experience- Candidate must have 2 to 6 years experience in a reputed pharma industry. Candidates must be willing to work in shifts Candidate who have faced regulatory Audits like FDA & MHRA Audit will be preferred.

Manager or Deputy Manager - Inventory & Manufacturing -Finance

Hyderabad

6 - 11 years

INR 0.5 - 0.5 Lacs P.A.

Work from Office

Full Time

POSITION PURPOSE A brief summary of the purpose this position must fulfill. As part of Viatris Global Business Services (GBS) the Inventory and Manufacturing Centre of Excellence (I&M COE) specializes in financial management and accounting for inventory and manufacturing operations as well as overseeing the transfer price setting through system support across the Viatris global network. Focusing talent in the newly created COE enables Viatris to deliver best in class service while scaling the business to achieve operational excellence. The I&M COE are key business advisors fostered by a culture of continuous improvement, collaboration and employee development. The Manager is responsible for overseeing the end-to-end accounting across their team. The team is responsible for the continuous support of the finance operations for Viatris local manufacturing plants and commercial sites in their daily operations and partnering to achieve their strategic initiatives. The role holder will also need to liaise with other functions such as Viatris’ Intercompany Operations (IO) Finance team and Viatris’ Supply Chain Team & reporting teams. In addition, the role will interact with Global Tax, Big4 tax advisors, external and internal auditors. The role holder should have a clear understanding of management accounting. They should be knowledgeable and comfortable with inventory accounting principles and PPV processes to excel in the position. Additionally, they should be comfortable navigating issue resolution, controls, audit and reporting related processes – access management and KPI reporting. IT literacy and experience using enterprise performance management systems is important (SAP experience is required for the role, Hyperion experience is an advantage for the position). Experience in people management is also an advantage for this role. As manger, the position requires the individual to use their leadership skills to support their direct reports in their month-end activities, as well as managing relationships with our key stakeholders. Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, departmental processes and ensures that all Service Level Agreements and KPIs are met. POSITION CONTEXT A brief summary of the context of this position. Global Business Services (GBS) is an organization which offers services to all Viatris units. The goal is to provide scalable, sustainable and streamlined service delivery. From a shared service concept, the employee executes services as agreed with the GBS customers. At Viatris we offer a wide range of benefits and programs that are tailored locally to meet the unique needs of employees to help them achieve what matters most. We recognize and reward the Viatris team in many ways: Hybrid work arrangements in most locations Benefits for health and financial wellness, including education and activities designed to help employees and their families live a healthy lifestyle Paid time off and holidays Retirement savings plans Competitive compensation programs Career and development planning for continuous growth and learning Volunteer opportunities in support of community and charitable organizations ESSENTIAL DUTIES AND RESPONSIBILITIES Manager will oversee/support work carried out by their team in the areas laid out below. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Manufacturing and Inventory area - Analysis and reporting of PPV (Purchase Price Variance) and MUV (manufacturing usage variance), working with the site to identify and resolve such issues. - Analysis of manufacturing and overhead spend. - Analysis & maintenance of standard cost and PRIME profit factors. - Run reconciliations from SAP against PRIME (transfer price setting tool) and HFM (consolidation tool). - Accruals review and reversals. - Perform corporate reporting and reconciliations for inventory & sales/cogs data. - Review and analysis of inventory reserves & net inventory. - Amortization & deferrals of variances. PRIME (Transfer Pricing and IC margin elimination) - Manage for a set of entities the process of collecting data inputs into the PRIME system for the annual transfer price setting. - Gather, cleanse, and organize necessary data for the monthly updating of the PRIME system for new or updated products. - Follow up with relevant stakeholders to address incomplete or inaccurate data. - Conduct profit factor analysis to ensure the completeness and accuracy of system updates. - Representing the point of contact for a set of entities for PII (profit in inventory) and cogs credit. General - Work with other organizations, such as Master Data, Procurement and General Ledger, Account Payable, Accounts Receivable, and internal and external Stakeholders to ensure process efficiency and maintain business relationships. - Ensure that SOPs (Standard Operating Procedures) and Internal controls over financial reporting are properly documented and updated. - Complete assigned job functions within a dynamic support organization to accomplish departmental goals. - Ensure all duties are performed within the guidelines of the company's internal controls, policies, and procedures. - Responsible for month-end closings and reconciliations within required deadlines. Ensure the proper application of both GAAP and local statutory requirements over transactions impacting trial balance and balance sheet. - Support audits, internal & external. - Perform other duties as assigned.

Senior Associate To Senior Team Leader - Engineering

Bengaluru

6 - 11 years

INR 5.0 - 15.0 Lacs P.A.

Work from Office

Full Time

We are hiring for multiple engineering roles in our Sterile Manufacturing Facility and are looking for skilled professionals in Mechanical and Electrical Maintenance with relevant sterile shop floor experience. The ideal candidates should have hands-on exposure to sterile area equipment, preventive and breakdown maintenance, troubleshooting, and facility upkeep. Qualification : BE / Btech Mechanical /Electrical Experience : 5 -15 yrs Key Responsibilities: Operation and maintenance of vial washing, tunnels, filling & sealing machines, manufacturing vessels Exposure to Lyophilizers and Auto-loading systems (for Executive/Associate roles) Performing Preventive Maintenance, Breakdown Maintenance, and Troubleshooting Knowledge of sterile manufacturing environments and regulatory requirements Conduct breakdown analysis and maintain metrics like MTTR / MTBF Overall facility maintenance responsibility Proficiency in English communication If you or someone you know fits the bill, please share profiles at Kirti.k@viatris.com. Also Kindly share your updated CV along with below details: Current CTC: Expected CTC: Notice Period:

Associate /Senior Associate - Production

Bengaluru

2 - 6 years

INR 3.0 - 6.0 Lacs P.A.

Work from Office

Full Time

Production : Associate /Senior Associate Qualification : B. Pharmacy / M. Pharmacy Experience : 2 to 6 years Must have Injectable and Regulatory Knowledge in any of these areas: Aseptic processing activity (Vial/PFS), Bulk compounding, sterilization,Vial washing & Depyrogenation,Lyophilization & Terminal sterilization process. Infusion bags processing activities, In-process checks and Line Clearance activities, Handling of shift activities and manpower. Computer Proficiency: TW, Documentum , MES & SAP, GEP

Senior Associate - Micro

Bengaluru

2 - 5 years

INR 2.0 - 5.0 Lacs P.A.

Work from Office

Full Time

Candidates must have Injectable and Regulatory Knowledge in following areas: Aseptic Processing Handling EM excursions Viable environmental monitoring Microbial limit testing Contamination control Trend Analysis Disinfectant efficacy studies Risk Assessment for Aseptic operations Key Responsibilities: Viable Environmental monitoring Trend Analysis Handling EM excursions Computer Proficiency : LIMS, MODA Candidates should be willing to work in shifts.

Group Leader- Packaging Development

Bengaluru

10 - 15 years

INR 15.0 - 20.0 Lacs P.A.

Work from Office

Full Time

Role & responsibilities Opportunity in our Packaging Development function of Injectable R&D at Bangalore. The role holder is responsible for the activities related to primary & secondary packaging materials of new development projects Preferred candidate profile Candidate with project management and technical skills while partnering with R&D, manufacturing sites, and component suppliers to develop medical device for new product launches for combination product for the export markets. Identify and develop innovative technologies to meet user needs through an effective balance of internal and external development activities. Conducting Human Factor/Transportation Study wherever necessary for Pens/Auto Injectors/IV bag/Ophthalmic container etc. Understanding of functionality testing of PFS, Cartridge, Devices & Bag as per regulatory requirement Understanding of the regulatory and compliance requirements for combination products as per 21 CFR 820.30, ISO & FDA guidelines for combination products & HF study Exposure to all ISO guideline required for development of complex injectable i.e; ISO 11040, 14971, 13485,11608, 10993, 15747, 7886 etc. Support for dossier submission and fulfil of agency queries. Execution of packaging development activities in alignment with the elements of Design Controls and ensure that all packaging materials/systems comply with departmental and applicable regulatory requirements. Participating in New Product Development /Packaging Development from conceptualization to commercial production with respect to Packaging design, Device finalization, Functionality, appearance, machines Create, improve, and maintain Design Control and Quality Management System procedures in collaboration with Quality and Regulatory. Understanding of EU MDR guidelines Comprehending technical data and writing drug-device related regulatory documents- Design and Development Plans, Design History Files, Finished Product Risk Assessments, Threshold Analysis, QSR compliance summary documents, FMEAs, Fault tree Analysis, etc.

Senior Associate or Senior Executive - QC (Manufacturing Unit)

Bengaluru

2 - 5 years

INR 3.0 - 7.0 Lacs P.A.

Work from Office

Full Time

Location - Manufacturing Unit, Bommasandra Qualification - MSc - Chemistry Experience - 2- 5 yrs Role : Analyst LCMS/HRMS Key Job responsibilities: Analyst should able to carryout testing in method transfer and method verification activities. Subject matter expert on analysis of HPLC, LCMS, GCMS for both assay and impurities routine samples of in process, cleaning validation, SFG & Stability. Subject matter expert in analysis of nitrosamine impurities. Subject matter expert calibration of instrument and its management.

Officer - Quality Control / Quality Assurance

Nashik

1 - 4 years

INR 2.0 - 4.75 Lacs P.A.

Work from Office

Full Time

Role: Officer - Quality Control / Quality Assurance Job Location: Nashik At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access Providing high quality trusted medicines regardless of geography or circumstance; Leadership Advancing sustainable operations and innovative solutions to improve patient health; and Partnership Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here's how this role, will make an impact: Role Purpose We have Openings in Both QC and QA(IPQA / Documentation / QMS / AQA) . Seeking for candidates (Male/Female) with sound qualification background to ensure the testing of drug product in Quality control lab and to ensure every product is of the highest quality. They shall be concerned with sampling, specifications, testing, documentation, release procedures which ensure that the necessary and relevant tests are carried out under the norms of cGMP. Role & responsibilities Candidate must have relevant experience in Quality control OSD and QMS and able to operate & maintain laboratory equipment/instruments (HPLC, GC, Malvern Particle sizer, dissolution apparatus etc.) as per procedure. To maintain documents as per GLP requirements. To ensure the calibration status of laboratory equipment & instruments. To report and involve in incidence/Deviation/OOS/OOT investigations. Candidate must have sound exposure in the Quality Control Laboratory to supervise and maintain documents and retention of records as per GMP requirements. To ensure the review of QC documents like analytical reports SOPS, Qualification, Logbooks, Raw data sheet, analytical records, calibration and ensuring compliance to observations with proper root cause and justifications. Candidates participate in initiation, review, and closure of OOS/OOT and monitor the CAPA with implementation in Track wise. To ensure the compliance of the Corrective and Preventive Actions (CAPA) necessitated through various activities such as Regulatory Audits, Market Complaints, and Product Recall & Annual Product Review in the QC if applicable. To support Quality Assurance / Compliance /Regulatory Systems, Processes and ensure Monitoring, Execution, Initiation of the Quality Management Systems in Quality Control laboratory. Qualification & Experience Candidate must be B. Pharm/ M. Pharma/ M. Sc In Chemistry Experience- Candidate must have 1 to 4 years experience in a reputed pharma industry. Candidates must be willing to work in shifts Candidate who have faced regulatory Audits like FDA & MHRA Audit will be preferred.

Executive

Bengaluru

4 - 8 years

INR 7.0 - 14.0 Lacs P.A.

Work from Office

Full Time

Opportunity for the candidates experienced into Individual Case Safety Report (ICSR) activities. This role is to manage the vendor responsible for outsourced Individual Case Safety Report (ICSR) activities. This includes ensuring compliance with contractual obligations, monitoring performance metrics, addressing operational challenges, and maintaining alignment with regulatory requirements. The role serves as the primary liaison between the organization and the vendor, fostering effective communication, ensuring quality deliverables, and driving continuous improvement in the outsourced processes to meet organizational goals and regulatory standards. Role & responsibilities Monitoring the vendor for all the Individual cases safety reporting (ICSR) outsourced activities. Manage the daily workload of ICSR in conjunction with manager, PV operations designee and any other task relevant to PV activities. Managing the Vendors on case prioritization on the basis Regulatory and business partner timelines. Preforming the daily and monthly reconciliation for the vendor locked cases for billing confirmation including the turnaround time (TAT) calculation. Attending the meeting/discussion with the vendor and providing the valuable process enhancement ideas for the process improvement. Having oversight on Viatris safety mailboxes to ensure that all the incoming mails are attended to diligently and the relevant actions are completed. Liaising with Global PV-Ops teams and affiliates to ensure global procedures are adhered to the process. Assist in answering queries and ensuring all cases received from global affiliates via the group mailbox are dealt with timely manner. Taking the knowledge enhancement sessions on all the latest regulatory guidelines and presenting the latest update on all procedural documents. Conducting the monthly and ad-hoc compliance meetings. Training the Vendor team on ad hoc basis and collaborates with the Training team lead to ensure training compliance met within PSRM department. As necessary, lead/support audit/inspection readiness activities and represents quality and compliance during audits and inspections. Support conduct of inspections and audits and closely collaborate with relevant stakeholders in preparation of internal audits and regulatory inspections. Manages and maintains an effective corrective action and preventive actions (CAPA) process including but not limited to the tracking, trend analysis and implementation of quality improvement measures and effectiveness checks. Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses (pending and final) and resulting measures. Preferred candidate profile Health care professional with experience in Pharmacovigilance and vendor management preferred.

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