ResponsibilitiesDrafting of Annual Monitoring and Certification report for incoming materials. Drafting / Negotiation (if applicable) and Archival of Quality Assurance Agreement with Suppliers/Service providers. Evaluation and Management of Supplier Change Notifications (SCN) and Initiation of quality record for the applicable SCN. Drafting and Evaluation of Supplier’s incoming materials Specification. Performing Quality Risk Assessment (QRA) for existing and new Suppliers / Service providers. Management of Supplier/ Material qualification and supplier related documentation. Preparation of regulatory statement for materials and finished products. Management Quality records, Support the Service Delivery team (SDT) with quality topics and 3rdPAP Management in TPRM (Third Party Risk Management) tool. Coordination with stakeholders in SIM (Supplier Information Management) approval process for Quality deliverables. Preparation of relevant contributing report for respective APQR section. Evaluation of change control tasks/ deviations related to supplier quality management. Audit preparation support, QARP and FURP Role for audit and CAPA Management. Responsible for the Functional representative activities. End to end deliverables for supplier / Vendor quality management activities as per the delegated task from the business partner. Qualification & ExpeirenceEducation: M. Pharma / B Pharma / MSc or Equivalent from Reputed university. Experience: 8 Years of pharmaceutical Quality experience preferably in Supplier Quality Management area. Basic Project management skills English fluent, written and spoken.

Responsibilities  Define, organize, plan and execute analytical development and characterization activities of pharmaceutical injectables in compliance with current international/regional/national regulations and guidance (cGLP, cGMP, GDP) with the support of senior colleagues, own team members, and global cross-functional teams. Work with and interpret data of advanced instrumentation techniques, hyphenated techniques, and other analytical techniques. Conduct failure analysis and root cause analysis in new product development and sustaining product projects within specified timelines, under supervision. Engage in science-based troubleshooting of the analytical issues and product development challenges. Provide proposals for product development related innovations, analytical method innovations, and product/process improvement initiatives in collaboration with senior scientists. Ensure good cross-functional communication and collaboration to drive allotted activities to timely completion. Preparation of scientific reports, proposals, and presentations Perform the calibration and maintenance of laboratory instruments and equipment. 

ResponsibilitiesTo review executed protocols of equipment, utility, process validation, cleaning validation, Utility and facility /HVAC qualification. To coordinate with cross functional departments for execution of all validation activities & escalate to HOD regarding any non-conformity from planning. To review calendars for various periodic qualifications & get it reviewed and approved by HOD. To track QMS documents like Change Control Management, Corrective and Preventive Action, OOS and Non-conformance for the validation activity and review and approve the investigation report. To ensure timely closure of the DCRs, CCM tasks, investigation report due to any NCR/OOS. To ensure timely completion of the self and subordinated assigned trainings. To participate in the Change Control Pre- Assessment meetings and perform the impact assessment of the assigned change controls in Trackwise. To review and approve the scheduled validation activity as per monthly calendar and send it to the cross functional & Planning department in advance for execution planning before the scheduled date. To ensure implementation of validation, qualification activities & inform HOD for any non-conformity deviated from written procedure. To ensure timely/contemporaneous (wherever applicable) data recording and compilation of reports during execution. To co-ordinate with projects and other cross functional departments. for prior information on new equipment installation and review respective protocol in TcU followed by qualification of new equipment and get it approved by HOD. To review summary report for submission to International Regulatory Affairs (IRA) as a part of queries or ANDA submission.

ResponsibilitiesAggregate Safety Report (PSUR/ PBRER/ PADER) related activity Responsible to provide PV support for new submissions and Post approval activities for Pharma Segment RFI Evaluation, Authoring Support activities (ASG) for PSUR/ PBRER/ PADER and ACO scheduling and submission Review and preparation of PADER/ PSUR/ PBRER, coordination for their submission as per schedule Handling of request received from central and local regulatory affairs and PV department with respect of timeline RMP Related activities Assist in developing RMP and allied activities Coordinate with Global RMP team as well as in-house reg team to ensure RMPs are submitted as per their applicable dates

ResponsibilitiesAnalytics and Insight Generation: Participate in the design and execution of secondary data analytics to support strategic decision-making by helping implement solutions, tracking progress, and coordinating results readout. Support insights generation in the integration of secondary data sources and collaborate with cross functional CD&A colleagues to understand key business needs Provide analysis using complex data sources including HCP and Account-level Demand data, Claims data, Electronic Medical Records data, Specialty Pharmacy data, etc. to generate a holistic, objective, and detailed understanding of the brand Stakeholder and Cross Functional Team Collaboration: Collaborate with teams in the US, Portugal to align on business rules and methodology for data analysis Contribute to the enhancement of the CD&A team's capabilities by researching and implementing new analytical tools, methodologies, and data sources Process & Capability Enablement: Contribute to building new capability / tool development in Amgen India. Help develop standardized data tables to enable faster insight generation. Technology & Innovation: Leverage AI tools (e.g., ChatGPT, agentic research platforms) to enhance speed and depth of insights. Stay current with recent trends in data visualization and analysis techniques Qualification & ExperienceBachelor’s degree and 3 to 6 years of relevant experience in pharmaceutical f commercial analytics or forecastin orMaster’s degree and 2 to 4 years of relevant experience in pharmaceutical analytics or forecasting

ResponsibilitiesEnsure compliance with all applicable cGMP directives, regulations, and guidelines to maintain the high quality of pharmaceutical products. Lead and oversee deviation investigations, ensuring compliance with Teva corporate procedures and local quality procedures. Perform impact and risk assessments for critical quality events. Assess and categorize deviations and determine the impact on affected batches. Coordinate with Teva affiliates regarding deviations that may affect product deliveries. Review and evaluate deviation reports from contract manufacturers, assessing their potential impact on the batch release process in collaboration with the responsible Teva release QP. Participate in regulatory inspections, Teva corporate inspections, and internal self-inspections within the scope of responsibility. Collect and analyse quality data and documentation, prepare documentation packages for Quality Alignment Meetings (QAMs) and Market Action Committees (MACs) in accordance with approved templates, and prepare Health Authority (HA) notification letters. Monitor and trend deviations and quality metrics to identify improvement opportunities. Prepare and report KPIs related to quality events and deviation management. Author and maintain local SOPs related to critical quality issues, deviation management, CAPA, and CAPA effectiveness.Qualification & ExperienceExperience in pharmaceutical manufacturing/validation/other related experience and/or in analytical control and regulatory compliance Master’s degree in pharmacy, chemistry, similar natural sciences, engineering or at least several years working experience in the quality assurance area Understanding of the drug manufacturing process. Knowledge of generics and branded product development is a plus Good interpersonal and communication skills, as well as organizational skills Ability to communicate complex issues, decision-making, problem-solving skills Proficient in written and spoken English Proficiency in MS Office, SAP, Veeva

ResponsibilitiesReceipt, registration and upkeep of all the samples/standards/excipients in the laboratory. Perform analysis as planned in the individual sections to adhere to the schedules and meet the commitments made by the individual sections. Analysis to be performed based on the qualification matrix of the analyst. Timely and error free documentation as per the GLP requirement. Perform Glorya related activities. Calibrations of Laboratory Instruments and Equipment. Preparation of reagents and standardization of volumetric solutions. Submission of approved reports to Quality Assurance. Responsible for SAP related activities. Handling of Trackwise harmony system for trackwise related activities. Revision and updation of Standard Operating Procedures, test methods and specifications. Analysis and reporting of results in LIMS software.Qualification & Experience4 to 7 years M.Sc Chemistry

ResponsibilitiesLeads the Quality organization on site including Quality Control, Microbiology, Quality Compliance, Quality Systems and Quality Assurance Operations. Ensure a current Quality Management System is in place and continuously improved Ensure products are manufactured, released and distributed in accordance to cGMP requirements and registered specifications. Most senior professional and independent decision maker authority on product quality and potential market actions Assess and Mitigate Risks-- Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply Design and Implement the Site Quality Program—Collaborate with the Site GM and Corporate Quality to create, implement, monitor and update the site quality program. Manage Quality Data--Oversee the delivery of necessary data to site managers and supervisors, Corporate Quality and other internal and external stakeholders, to support the achievement of Quality objectives and ensure compliance Direct Quality Control-- Oversee the laboratory activity, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products for the site Promote a Sustainable Culture of Quality---Create, develop and maintain a culture of enhancing quality throughout the entire site operation. Create a space where people can speak openly and are encouraged to present new ideas to improve quality Maintain strong partnership with site leadership team Strategic partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure project timelines and objectives are met Provide effective Quality leadership during internal, customer and Health Authority inspections Ensure that Quality KPIs are meeting pre-defined targets, Ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically Plans, manages and monitors the annual Quality Operations budget and all its resources and employees. Ensure the performance and utilization of resources to provide maximum efficiency to the organization. Qualification & ExpeirenceRequired – bachelor’s degree in chemistry, Biology, Pharmacy Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy Key Requirements Minimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience, including: Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process, 

Responsibilities  Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.  Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.  Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.  Enters data into safety database.  Codes events, medical history, concomitant medications, and tests.  Compiles complete narrative summaries.  Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.  Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.  Maintains safety tracking for assigned activities.  Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.  Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.  Manual recoding of un-recoded product and substance terms arises from ICSRs.  Identification and management of duplicate ICSRs.  Activities related to SPOR / IDMP.  Quality review of ICSRs.  Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.  Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.  Fosters constructive and professional working relationships with all project team members, internal and external.  Participates in audits as required/appropriate.  Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities. Qualification & ExperienceEducation: B. Pharm / M. Pharm / BDS / BMS / MBBS (No BSc / MSc)Minimum 6 years of PV experience, and Min 3+ years of QC experience is mandatory

ResponsibilitiesResponsible for providing operational and administrative support to one or more clinical functions. Responsibilities may include but are not limited to: Provide administrative support by coordinating project documentation and communications, including maintaining shared mailboxes, organizing project files, tracking action items, and ensuring timely follow up with cross functional stakeholders. • Enter, maintain and reconcile information in agreed project and clinical tracking systems. • Timeline, milestone tracking, and risk projection. Investigate and provide clear rationale for delays, provide support on contingency plan to mitigate risk • Perform document management activities including document creation, compilation, formatting, version control, and quality control (QC). • Translation of documents using approved vendors/systems • Support audits and inspections as requested. • Use AI-enabled tools, dashboards, and automated reports to provide logistical, organizational, and analytical support • Support Trial Master File (TMF) filing and related document process activities within scope, ensuring inspection-ready documentation. • Training and mentoring junior-level Clinical Operations Associates • Responsible for providing quality deliverables. Follow project requirements and applicable country rules, with oversight at the project level from functional leads. • Review and comply with applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs), ensure training compliance, and maintain accurate timesheet reporting. • Monitor workload/scope, budgeted effort, and project hours; escalate discrepancies in a timely manner • Maintains overall awareness in the field of clinical research by completing all necessary and assigned training Qualification & ExperienceBachelor’s Degree or equivalent combination of education, training and experience. 2 to 4 years clinical operations experience Provide operational and administrative support to CRAs and Country Regulatory Specialists within the site activation and regulatory submissions functions. Good understanding in clinical research, drug discovery, clinical trials (setup, maintenance, closeout). Must have good communication (Verbal & Written)