Appasamy Associates

##Hiring ##POSITION: Assistant Manager- Quality Control (QC) ##INDUSTRY : Biologics manufacturing ##LOCATION : Pondicherry (Thiruvandarkoil) ##To APPLY: sethuraman.gopal@appasamy.com careers@appasamy.com jagarlamudi.chandra@appasamy.com ##ROLE OVERVIEW : Responsible for overseeing and ensuring the quality and compliance of raw materials, in-process products, and finished biosimilar products, managing laboratory operations, coordinating testing procedures, and supporting the implementation of quality control systems in alignment with regulatory requirements and industry standards. ##ROLES & RESPONSIBILITIES : ##Sampling and Analysis: • Sampling of Raw Material and as per the relevant SOP’s and ensure proper storage as per Storage conditions for Raw Material, In process, stability sam-ples and Finish Product as per the relevant SOP’s • Analysis of Raw Materials, In Process, Finished goods and Stability sam-ples, as per the required specifications on time. • Ensure cGLP in the laboratory activities. • Carry out instrumental analysis of In process, Finished goods and Stability samples such as HPLC, UV-Vis Spectrophotometer, Potentiometer, IR spectrophotometer, TOC, Conductivity meter, pH Meter and Melting point etc. ##Documentation: • Prepare and maintain raw data and analytical records in compliance with the current regulatory requirements. • Maintain the raw data as per regulatory requirements. • Scanning and Proper Storage of Raw Material ATR in documentation store. • Review of logbooks, Calibration records, Qualification documents etc. • Review and revise the specifications and test procedures based on the pharmacopoeia • Raising deviations and implementation of CAPAs. • Perform qualification of new instruments. • HPLC trouble shooting. ##Calibration/Validation: • Carry out the calibrations and preventive maintenance of instruments as per SOP and maintain records. • Carry out the validation of analytical methods as per the testing procedure. ##EDUCATIONAL QUALIFICATION : Bachelors or Masters in science or pharmacy ##WORK EXPERIENCE : 4-8 Years ##Visit us :- www.appasamy.com

Join us at the BOA Winter Conference 2024! Appasamy Associates is excited to participate in this year’s conference, featuring Stall No. P3 & 11! Conference Dates: November 29th - December 1st Location: The Westin, Powai Lake, Mumbai Don't miss our live surgery demonstration and insightful scientific talks at Hall B & Hall D on November 29th! This is a fantastic opportunity to learn about the latest advancements in ophthalmology and connect with industry experts. We can’t wait to see you there! #boa2024 #APPASAMY #Ophthalmology #livesurgery #MumbaiConference #InnovationInEyecare

##Hiring Sales Executive AT – IOL Specialist Equipment Specialist Equipment Manager – Surgical Systems Be ready to be part of an exciting growth journey in India’s one of the largest ophthalmic organization ##Open Positions :- ##Sales Executive’s (1-5 yrs of experience in ophthalmic equipment sales) Baroda, Ahmedabad, Amritsar, Kolkata, Karimnagar, Hyderabad, Pondicherry ##AT – IOL Specialist (3-5 yrs of experience in IOL’s) Vijayawada, Bangalore, Hubli, Kanpur, Ahmedabad ##Equipment Specialist (3-5 yrs of experience in ophthalmic equipment specialist) Vijayawada, Patna, Indore ##Equipment Manager – Surgical Systems Patna, Ranchi, Raipur We’ are Looking for a person with : Strong problem-solving skills and attention to detail. Excellent communication and customer service abilities. Willingness to travel and support clients on-site. Visit us :- www.appasamy.com Apply now :- sethuraman.gopal@appasamy.com; himanee.bisen@appasamy.com careers@appasamy.com

##Hiring HR Recruiter Be ready to be part of an exciting growth journey in India’s one of the largest ophthalmic organization #Role : Sales Recruiter, across PAN India. Language: Hindi, English must. #Work Location: Ambattur, Chennai #Qualification: 2 to 3 years work experience in Sales Recruitment. Visit us :- www.appasamy.com Apply now :- sethuraman.gopal@appasamy.com; careers@appasamy.com

##Hiring ##POSITION: Assistance Manager- Quality Assurance (QA) ##INDUSTRY : Biologics manufacturing ##LOCATION : Pondicherry (Thiruvandarkoil) ##To APPLY: sethuraman.gopal@appasamy.com; careers@appasamy.com; biologics@appasamy.com ##ROLE OVERVIEW : Responsible for ensuring manufacturing and packaging opera-tions are operating under a state of cGMP compliance. ##ROLES & RESPONSIBILITIES : • Ensure proper sampling of materials and manage document control for shop floor quality. • Perform in-process inspections during manufacturing and packaging. • Review and approve master documents and printed packaging artwork. • Collaborate with Head of Quality Operations to maintain cGMP compliance across the site. • Allocate resources for CAPA, root cause analysis, preventive actions, and corrective actions in line with cGMP. • Direct manufacturing staff on quality issues, including line shutdowns for investigations. • Manage risks, optimize processes, and communicate with Quality Head and project teams, especially for new product launches. • Review and approve SOPs in Formulation, Engineering, Quality Control, Mi-crobiology, and Validation. • Experience in Qualification/Validation activities per regulatory and lifecycle requirements, including VMP/EQMP/CVMP. • Prepare stability protocols, schedules, and conduct stability studies for DS and DP products. • Select and audit vendors for KSM and PPM. • Oversee cleaning validation, including master plan, protocol, and report approvals. ##EDUCATIONAL QUALIFICATION : Bachelors or masters in science or pharmacy. #WORK EXPERIENCE : 6-8 Years ##Visit us :- www.appasamy.com

##Hiring Position :- Cloud Infrastructure Lead To have experience working in a wide range of services from End user computing to Cloud services management in a Secure digital native environment. Infrastructure capacity planning, budgeting and monitoring of services and credible experience in optimization of services across a wide range of Cloud environments is essential. ##Role & responsibilities Primary SPOC for Appasamy Associates Infrastructure Services – Network, Servers, App Databases, end user services and Cloud infra.. Cloud environments sizing, budgeting and planning. . Active assessment and implement Best practices on Infrastructure Security requirements and ownership on implementation across devices and server environments. Build a high performance Infra team who can deliver to the project plan across end user compute, networks and hyper scaled SaaS environments. Be responsible for Infra Budgeting and capacity planning and ongoing optimization. Actively collaborate inter-departmental dependencies working with peer groups using a level of influence and drive positive actions. Responsible for DR and BCP implementation plans and sustained monitoring of costs and benefits. Take ownership on upgrades, patches and plan to deliver the same with no unplanned business downtime. Shared ownership on cost optimization related to Cloud (RISE costs) deployment of SaaS solutions and ongoing RUN costs. On time and on budget provisioning of Infra services (SAP RISE and other Cloud platforms). Contribution to SAP RISE / SAP BTP Enterprise services sizing would be preferable. Security assessments and continuous upgrades, patching, network security and proactive monitoring. Availability of end user compute services, QoS of network and broader productivity tools. A people orientation towards training and focus on productivity as it relates to Infra. ##Technical Competencies :-** Strong knowledge of Hyperscale environments Has experience in SAP RISE sizing Credible Planning, Budgeting and provisioning experience in multi-Cloud environments. Service, application optimization and productivity of Cloud Infra Security, DR and BCP Desirable :- Should have experience in Manufacturing and desirable from Healthcare, Life Science. Cloud Infra certified on either of the platforms or SAP S4 HANA Cloud / SAP RISE ##Qualification :- Bachelor/Masters degree in Engineering or commensurate experience Desirable :- Cloud Infra certified on either of the platforms and / or SAP RISE ##Experience :- 12-15 yrs from a Manufacturing Industry and desirable from Medical Devices or in allied Healthcare or Life Sciences. Desirable :- Cross experience across Process and Discrete manufacturing setups. Job Location :- Chennai, Ambatur Visit us : www.appasamy.com Apply :- sethuraman.gopal@appasamy.com careers@appasamy.com

##Hiring Sales Executive’s, Service Engineer’s, AT – IOL Specialist Equipment Specialist Be ready to be part of an exciting growth journey in India’s one of the largest ophthalmic organization ##Open Positions :- ##Sales Executive’s (1-5 yrs of experience in ophthalmic equipment sales) ##Field Service Engineer’s (1-5 yrs of experience in ophthalmic equipment Service) ##AT – IOL Specialist (3-5 yrs of experience in IOL’s) ##Equipment Specialist (3-5 yrs of experience in ophthalmic equipment specialist) #Location: Hyderabad, Vijayawada, Ahmedabad, Rajkot, Surat, Baroda, Patna, Ranchi, Raipur, Pondicherry, Kerala We’ are Looking for Strong problem-solving skills and attention to detail. Excellent communication and customer service abilities. Willingness to travel and support clients on-site. Visit us :- www.appasamy.com Apply now :- sethuraman.gopal@appasamy.com; careers@appasamy.com

##Hiring Position : SAP FICO LEAD Industry : Medical Equipments, Devices Manufacturing Company Location : Chennai ##Apply : sethuraman.gopal@appasamy.com careers@appasamy.com ##Role Overview :- Primary SPOC for the SAP FICO working closely with the IT and business functional peer groups and steer the key decisions related to Solution Blueprinting, Configuration and Test management and Change management to bring in a mature SAP ecosystem into Appasamy Associates. The role requires to take ownership on all aspects to maintenance, cost and quality of service, including that related to upgrade / release management once of the implementation is completed. Primary SPOC for Appasamy Associates Finance team for the SAP implementation. SAP S/4 HANA Product Sizing SAP Vendor partnering in full life cycle implementation. Build a high performance SAP team across functional modules who can deliver to the project plan. Single point of ownership on Finance Scope management, cost management and Quality to production. Actively collaborate inter-departmental dependencies working with peer groups using a level of influence and drive positive actions. Build the process for SAP sustain / DevOps team who can deliver Operational support and ongoing changes based on business needs, priorities and cost-benefits evaluation. Take ownership on upgrades and plan to deliver the same with no unplanned business downtime. Shared ownership on cost optimization related to Cloud (RISE costs) deployment of SAP solutions and ongoing RUN costs. Technical Competencies Atleast 2 full lifecycle implementation playing the primary role in SAP FICO Lead SAP FI modules and sub-ledgers, including Accounts Payable (AP), Accounts Receivable (AR), and Asset Accounting (AA). Knowledge of Intercompany processes. Configure SAP FI/CO settings, including ledger setup, account determination, and integration with other module. Ensure that financial processes adhere to regulatory requirements and support audit processes by providing necessary documentation Understanding of technical components required to support business processes, including integration effort within different functional tracks. Good knowledge of associated S4/Hana FIORI Tiles, Launch Pad, Transactional apps, Personas. ##Education Qualification : Bachelor/Master’s degree in Engineering or commensurate experience. (Or) CA or Accounting professional with SAP FICO. ##Work Experience : 10-12 years. Manufacturing and desirable from Medical Devices or in allied Healthcare or Lifesciences.

##Hiring Plant Finance Controller Be ready to be part of an exciting growth journey in India’s one of the largest ophthalmic organization #Role : Plant Finance Controller #Work Location: Baddi, Himachal Pradesh ##Role Overview: We are seeking a Plant Controller to oversee financial operations and strategic planning at our manufacturing facility. The ideal candidate is a semi-qualified/Qualified CA/CMA with 10+ years of experience in financial management, particularly in the manufacturing sector. This role is critical for ensuring financial integrity, cost control, and compliance while supporting the plant's overall financial performance. This role also need to support Corporate HO team in helping them to deep dive the operation and other corporate activities in closure of books, helping closure of Statutory Audit and exceptional reporting. ##Roles & Responsibilities: ##Cost Management: Monitor and control manufacturing costs, including material, labour, and overhead. Analyse production costs, identifying cost-saving opportunities and efficiencies. Oversee inventory management and optimize inventory levels to minimize cost and maximize productivity. Product wise costing for Pharma products Financial Planning & Analysis: Lead the budgeting and forecasting process for the plant and overall company. Analyse variances between actuals and budget, identifying areas for improvement. Prepare monthly, quarterly, and annual plant wise financial reports to support management decisions. ##Compliance & Internal Controls: Ensure compliance with corporate policies, local laws, and industry regulations. Implement and maintain robust internal controls to safeguard plant assets. Collaborate with auditors and support internal and external audits. ##Strategic Partnership & Advisory: Act as a financial business partner to the plant's operations team. Support strategic decision-making processes by providing financial insights and recommendations. Collaborate with plant managers to improve operational efficiency and profitability. ##Leadership & Team Development: Lead and mentor a team of finance professionals within the plant. Foster a culture of continuous improvement and financial accountability. Identify training needs and support career development of finance team members. Contribution as part of SAP Implementation Team Need to play the key role in implementing Fixed Asset module Helping in Master clean up and creation of Chart of Accounts Helping in implementation of costing module #Work Experience: Semi-qualified/Qualified CA/CMA with 10+ years of experience in financial management particularly in the manufacturing sector. Visit us :- www.appasamy.com Apply now :- sethuraman.gopal@appasamy.com; careers@appasamy.com

##Hiring ##POSITION: Research Associate/Senior Research Associate ##INDUSTRY : Biopharma R & D, Biotech R & D ##LOCATION : Chennai, Ticel Park ##APPLY: sethuraman.gopal@appasamy.com; careers@appasamy.com ##ROLE OVERVIEW : SME in downstream process and actively involve in developing/improving Downstream unit operations. ##ROLES & RESPONSIBILITIES : Have strong knowledge and experience in process development and scale up of recombinant proteins and mAbs. Design strategies and specifications for early phase development and optimization of purification process. Ensure that manufacturing processes are capable, compliant, in control, cost-effective, and continuously improved. Regularly evaluate Tech Transfer operations, developing and implementing recommended and/or necessary improvements and changes. Provide a science-based approach for the resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies. Have expertise in downstream division of a large-scale Biopharmaceutical facility and thorough knowledge of Biosimilar, mAb purification (downstream) processes and current Good Manufacturing Practices (cGMP). Have previous experience in technology transfers into a clinical and/or commercial facility. Have experience of authoring process validation protocols and reports, risk assessment, handling of Incident investigation (Deviations), OOS / OOT and sound knowledge of QMS. Have hands-on experience in downstream unit operations such as Chromatography, Clarification, TFF, etc. ##EDUCATIONAL QUALIFICATION : M.Sc./M.Tech. Biotechnology or in Relevant discipline ##WORK EXPERIENCE : 4-8 Years