DESIGNATION: ANALYST DESIGN QUALITY ENGINEER Contract Duration: 12 - 24 Months PRIMARY RESPONSIBILITIES: Ensures that designs meet regulatory requirements, quality standards, and company policies throughout the product lifecycle (FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, ISO 14971) Review design documentation, specifications, and data to identify potential compliance gaps and quality issues. Responsible for developing and implementing compliance programs, identifying potential issues, and recommending corrective actions to ensure product safety, reliability, and efficacy. Maintain accurate and up-to-date documentation related to compliance activities, including test results, reports, and procedures. Hands-on experience in Design History File compilation / Technical file documentation. Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance. Possess a strong understanding of design principles, quality control standards, regulatory requirements, and problem-solving methodologies. QUALIFICATION: A graduate in Mechanical or related engineering and with 4-6 years related medical device /combination product design & development experience and product lifecycle management.

CDMA-Clinical Trials Supply Manager- Job Description 1. Lead & keep oversight independently all aspects of the clinical trial supplies for assigned clinical trials. 2. Evaluation and Selection of vendors/service providers for clinical trial supply management. 3. Oversee set up of IxRS tools, monitor the supply utilization, optimization, resupply, accountability, re-conciliation throughout the trial and destruction processes completed after trial completion. 4. Forecast clinical (Investigational and comparator, other Products) and ancillary (non-drug product) supply requirements. 5. Calculate clinical supply requirements and provide the requirements to internal team for supply readiness proactively. 6. Oversee the procurement of comparator and any additional drug products as required for clinical trials with necessary documents. 7. Co-ordinate and review the packaging & labelling activities including design of Product labels and expiry extension if any and oversee the label design and approval processes. 8. Liaise with internal functions of Biocon and external partners and providers (CRO, others) in driving the clinical supplies shipments and monitor the temperature excursions accordingly. 9. Create or update SOPs required for clinical trial supply management.

Mechanical Engineering - (Associate Manager/ Manager) Role & responsibilities Manage/support multiple projects that are ranging from new product development to life cycle management/ sustaining engineering. Defines design requirements and development specifications based on customer or user requirements. Contributes to development and documentation of mechanical system architectures. Contributes to ideations, troubleshooting and problem solving efforts related to new product development and sustaining projects. Hands-on experience in Design History File compilation / Technical file documentation. Good understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance Creates and develops designs of mechanical assemblies, mechanisms, and component parts for electro-mechanical medical devices meeting set requirements. Performs in-depth mechanical analysis and calculations including kinematic analysis, tolerance analysis, structural analysis- FEA to evaluate design robustness and to ensure consistent performance and safety of critical functions. Ensures successful integration of mechanical design elements with electrical and consumable components. Build and test design concepts and Engineering prototypes for verification. This includes compiling and presenting data to support design verification of new products in accordance with company and regulatory requirements. Lead activities related to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified. Must be able to participate in design reviews for reviewing the design changes & seek management approval to move forward. Preferred candidate profile A graduate or a postgraduate in Mechanical or related engineering and having minimum 8 years related experience. Exposure to medical device lifecycle management preferred. Hands on experience in electromechanical product development, preferably medical devices. Knowledge and experience using CAD systems for mechanical design and analysis (Solidworks preferred). Knowledge of standards such as IEC 60601, ANSI and ASTM preferred. Knowledge on Risk assessment, Root cause analysis procedures, DFMEA, PFMEA, ISO, etc is desirable. Knowledge of DFM & DFA with respect to ease of manufacture and assembly. Knowledge of Design and manufacturing Engineering of metal and plastic parts is required. Excellent communication skills- Written and oral such as Technical documentation, Presentation skills.

Position Overview: The Project Manager will play a critical role in managing and overseeing regulatory projects and initiatives across global markets. This position will be responsible for ensuring the timely and efficient management of regulatory submissions, maintaining compliance with relevant regulations, and working closely with cross-functional teams to drive global regulatory strategies for product approvals. Key Responsibilities: Global Project Leadership: Lead and manage the global regulatory project lifecycle for product submissions, ensuring alignment across multiple regions and compliance with local regulatory requirements. Develop detailed project plans, define timelines, allocate resources, and monitor the progress of regulatory activities across markets. Act as the primary point of contact for internal and external stakeholders, ensuring clear communication, and managing expectations throughout the project lifecycle. Data Analytics: Prepare reports and dashboards to visualize regulatory data and provide actionable insights to support decision-making. Collaborate with regulatory affairs teams to identify trends, bottlenecks, and opportunities for process optimization. Ensure data accuracy and integrity across regulatory databases and systems. Regulatory Strategy Development: Collaborate with senior regulatory leaders to develop and implement global regulatory strategies tailored to each market, ensuring timely approvals and compliance with regulatory standards. Provide expert guidance on regulatory pathways, requirements, and timelines to ensure smooth submissions and minimize delays. Cross-functional Collaboration: Partner with R&D, clinical, commercial, and legal teams to ensure product development aligns with regulatory requirements. Coordinate and manage interactions with regulatory agencies, ensuring timely responses to inquiries and ensuring a strong relationship with regulatory authorities. Lead cross-functional teams through regulatory milestones, ensuring that all stakeholders are aligned and informed. Regulatory Submissions & Approvals: Oversee the preparation and submission of regulatory filings, including INDs, NDAs, CTDs, and other regulatory documents, ensuring they are accurate, complete, and meet regulatory standards. Manage the submission process and monitor progress until approvals are granted, ensuring timely responses to any regulatory questions or requests for additional information. Risk Management & Problem Solving: Identify potential regulatory and project risks and develop mitigation strategies to proactively address challenges. Troubleshoot issues related to regulatory compliance, submissions, or product approvals, providing timely solutions to keep projects on track. Maintain up-to-date knowledge of industry trends, regulatory changes, and emerging issues that could impact the projects progress. Regulatory Intelligence & Continuous Improvement: Monitor and analyse global regulatory trends and provide guidance on evolving regulations in target markets. Share insights on regulatory best practices and contribute to the development of internal processes, templates, and tools to improve efficiency in regulatory project management. Proactively suggest improvements in workflows to streamline processes and ensure continuous improvement within the regulatory function. Stakeholder Reporting & Communication: Provide regular updates and reports on the status of regulatory projects, including timelines, milestones, risks, and progress to senior leadership and key stakeholders. Prepare and deliver presentations to senior management, providing clarity on regulatory project status and risk assessments. Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's or advanced degree preferred). Minimum 5-7 years of experience in regulatory affairs or project management in the pharmaceutical, biotechnology, or medical device industries. Experience with data analysis, data visualization tools (e.g., Excel, Tableau, Power BI), and familiarity with regulatory affairs processes. Proven track record of managing complex global regulatory projects, including submissions and approvals. Certification in Project Management (e.g., PMP) or Regulatory Affairs (e.g., RAC) is a plus. Experience with global regulatory submissions in multiple regions (e.g., FDA, EMA, ICH guidelines).

Key Responsibilities: Strong understanding of eCTD, NeeS, and ICH guidelines. Familiarity with Regulatory systems and Publishing tools. Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint. Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets) Manage lifecycle submissions including variations, amendments, and renewals. Perform document-level publishing, hyperlinking, bookmarking, and validation. Conduct quality control checks to ensure submission readiness. Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical. Stay updated with global regulatory guidelines (ICH, FDA, EMA). Detail-oriented with a collaborative mindset. Minimum Qualifications and Experience B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc. Minimum 4 to 8 years Preferred Qualifications/ Skills Proficiency in managing Regulatory eCTD Submission for all Global Markets. Good knowledge on eCTD Guidance and understanding validation criteria requirement. Strong communication and interpersonal skills. Experience with electronic submission (New Development Product Filings / LCM). Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously. High level of attention to detail and accuracy in document level publishing and submission compilation/validation. Ability to work collaboratively in a cross-functional team environment. Proficiency in using regulatory databases, information management systems, and other relevant software tools. Commitment to staying updated on regulatory changes and advancements in the field.

GRC Intern , you will assist in investigating Whistleblower (WB) cases , ensuring compliance with governance frameworks, risk management policies, and regulatory requirements. This role provides hands-on experience in corporate investigations, compliance reporting, and ethical governance while supporting training and documentation initiatives Key Responsibilities : Assist senior team members in investigating WB cases , ensuring adherence to legal, ethical, and governance standards. Review and analyze reports, records, and transaction data to identify potential compliance concerns. Support case documentation , maintaining structured records and dashboards for investigation tracking and reporting. Develop and present investigation findings, compliance summaries, and case analysis reports using data visualization tools. Prepare PowerPoint presentations for WB awareness training and compliance briefings. Collaborate with legal, compliance, and risk management teams to ensure a thorough investigation process. Gather and assess evidence, including interviews, statements, and digital records , to support WB case evaluations. Assist in conducting compliance training sessions , educating employees on WB reporting procedures and governance policies. Maintain confidentiality while ensuring adherence to legal, ethical, and regulatory frameworks throughout all investigation activities. Stay updated on emerging governance, risk, and compliance trends , enhancing investigation methodologies. Qualifications : Bachelors degree in accounting, finance, law, criminal justice, or related fields . Strong analytical, problem-solving, and investigative skills . Ability to create structured reports, dashboards (Excel, Power BI), and PowerPoint presentations . Effective communication and presentation skills for reporting investigation findings. Basic knowledge of laws, compliance frameworks, and risk management protocols related to WB cases. High levels of integrity, ethical conduct, and attention to detail . Training and Development : This role provides structured training on WB case investigation methodologies, compliance reporting, data analysis tools, and ethical governance practices . You will gain exposure to case documentation, dashboard tracking, and professional presentation development . Career Growth : Exceptional performance can lead to opportunities in compliance, risk management, or corporate investigation roles , strengthening expertise in governance and ethical business practices.

Biocon Biologics is a fully-integrated pure play biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's rst publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe. Key Skills: Communication & Interpersonal Skills: Effectively communicate with employees, managers, and other stakeholders. Further ensuring complete support to HR Programs and assisting senior HRBPs Analytical & Problem-Solving Skills: Analyze HR data, identify problems, and develop solutions. Business Acumen: A strong understanding of the business and its strategic goals. Employee Relations Expertise: Ability to handle employee relations issues and foster a positive work environment. Execution of various employee engagement programs Knowledge of HR Laws & Regulations: Thorough understanding of relevant laws and regulations. Talent Management Expertise: Experience in attracting, developing, and retaining talent. Support in ongoing process and ensure adherence from designated BUs Data Analysis & Reporting: Ability to analyze HR data and create report

Key Responsibilities Implementing and configuring SAP FICO requirements, setting up financial accounting and controlling processes, analysing and improving business processes, customizing and configuring to meet the requirement with standard SAP, testing and support along with the user training, documenting configuration and procedures. Professional Experience / Qualification: CA/ CMA / MBA in Finance, including a minimum of 3 years of experience on core finance & accounts and 8 to 10 years of experience as a FICO consultant or Lead handling SAP ECC / SAP S/4HANA implementation, enhancements and support. In-dept understanding of Finance & Controlling sub-modules like General Ledger, Accounts Payable, Accounts Receivable, Asset Accounting, Cost Elements, Cost Centre Accounting, Profit Centre Accounting, Product Costing, Material Ledger and Actual Costing. Understanding on Funds Management, Business Planning & Consolidation, Inter-Company transaction and Reconciliation, Project System. Experience in working in an on-site & offshore model, coordinating with stakeholders from various geographical locations. Excellent oral / written communication skills. Self-starter, with the ability to work and execute independently with minimal guidance. SAP FI/CO certification is a good to have.

Job Summary: As a Senior Nutanix HCI Administrator, you will be responsible for the design, implementation, administration, and optimisation of Nutanix Hyperconverged Infrastructure (HCI) within a highly regulated, performance-critical environment. This role involves managing virtualised environments, data centre infrastructure, and enterprise IT systems, with a strong focus on stability, performance, security, and scalability. Key Responsibilities: 1. Nutanix HCI Administration: Design, deploy, and manage Nutanix clusters using AHV and Prism Central. Monitor performance, conduct capacity planning, and manage lifecycle upgrades for Nutanix infrastructure. Implement disaster recovery and business continuity strategies using Nutanix-native tools (e.g., Leap, Xi). Troubleshoot issues across the HCI stack, including storage, compute, and network layers. 2. Virtualization & Server Infrastructure: Manage mixed virtualisation environments (AHV, VMware, Hyper-V) across multiple sites. Oversee provisioning, migration, and maintenance of virtual machines for business-critical systems (MES, Serialization, etc.). Implement and maintain OS-level configurations (Windows Server, Linux). 3. Data Centre & Enterprise Systems: Operate and monitor enterprise data centre environments for performance, uptime, and compliance. Maintain OT Network NAS infrastructure and integration with production systems. Ensure secure and compliant data-handling practices aligned with pharmaceutical Good Manufacturing Practice (GxP) standards. 4. Application & Platform Support: Support the deployment and lifecycle of applications hosted on Nutanix clusters. Maintain Active Directory integrations and ensure role-based access control across all platforms. Administer ITSM tools such as Symphony AI Summit for incident, problem, and change management. 5. Backup & Recovery: Implement and manage backup strategies using Nutanix-native or integrated backup tools. Regularly perform and test system restorations to validate recovery readiness. 6. Security & Compliance: Regularly to maintain compliance and ensure a secure posture. Collaborate closely with compliance teams to ensure that infrastructure adheres to pharmaceutical regulatory standards. Perform risk assessments and maintain audit-ready documentation. 7. Collaboration, Support & Operations: Coordinate with OEMs to resolve support tickets, implement upgrades, and escalate issues. Collaborate with OT/IT teams during planned shutdowns or infrastructure changes. Lead infrastructure projects across global sites, ensuring the harmonisation of practices and standards. 8. Project Leadership & Policy Implementation: Contribute to IT policy implementation across global manufacturing environments. Lead initiatives to standardise IT infrastructure (e.g., meeting room technology, site IT configurations). Provide guidance and mentorship to junior team members. Qualifications and Requirements: Bachelors degree in computer science, Information Technology, or related field. 7-9 years of experience in IT Infrastructure roles with at least 3+ years focused on Nutanix HCI. Advanced understanding of Nutanix Acropolis (AHV), Prism Central, Calm, and other Nutanix toolsets. Strong experience with virtualisation platforms: AHV and knowledge about VMware vSphere, Hyper-V. Good to have Experience in managing infrastructure supporting manufacturing or pharmaceutical environments (GxP knowledge is a plus). Solid understanding of data centre design, high availability, DR, and NAS/SAN storage. Strong scripting and automation knowledge (e.g., PowerShell, Bash) is a plus. Professional certifications (e.g., NCP, VCP, Microsoft Certified: Azure Administrator) are desirable. Excellent analytical, troubleshooting, and communication skills. Ability to manage priorities in a fast-paced, multi-project environment. Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act.

Responsibilities : To follow the established procedures and policies of the company pertaining to EHS. To carryout duty as prescribed in the KFR -1969 rule 88A (Q) sub rule 3 duties of the safety officer. To adhere to safety norms defined To understand the implications of not following the defined procedures with respect to EHS To co-ordinate Safety Committee meetings To impart/coordinate Safety Trainings and activities To ensure proper maintenance of Safety Gadgets and system To ensure the effectiveness of the action taken or proposed to be taken to prevent personal injuries and ill health arising out of occupational work environment. To co-ordinate for incident investigation of occupational related incidents. To co-ordinate in investigating the cases of industrial diseases contacted and dangerous occurrence To co -ordinate campaigns, competitions, contest and other activities which will develop and maintain the interest of the employees in establishing and maintaining safe conditions of work and procedure To coordinate with safety consultants to conduct EHS Audits. To prepare Safety capex budget. To implement, maintain and continually improve the Work Permit System. To coordinate in Conducting Emergency Preparedness and Response Drills. To schedule the Safety Audits/ trainings /activities. To co-ordinate Annual Health Check-up for the employees/ contract workmen. To ensure proper distribution of First-Aid items and conduct first aid box audits. To Process safety management Ensure and implementation Accountability: Ensure and implementation of EHS management system. Authorities: To raise safety violation and comply with safety violation procedure. To give clearance for those works coming under the Work Permit System. To cancel the work permit in case of any safety violation during the pendency of the work permit. To issue the General Training Record/ CKL /Annexure. To Prepare and review SOP/IOP/EOP/OCP related to Occupational Health and Safety activities and work environment. Degree in B tech /BE ( chemical ) and Post Diploma industrial safety course completed from DOF Govt of Karnataka /state govt approved recognized institute. as per KFR-1969 88(a). Minimum 4 to 8 years of pharmaceutical industrial experience in EHS Activities

Plan and implement company talent acquisition strategy Conduct sourcing activities to fill open positions Perform analysis of organizational development and anticipate future employment needs Involve in recruitment and selection processes (resume screening, screening calls, interviews etc.) Reviews employment applications Serve as brand ambassador at various events, like career fairs or on-campus recruiting events Represent company internally and externally at events with a goal of networking and relationship building with potential candidate communities Counsel the candidate on corporate benefits, salary, and corporate environment Build long-term relationships with past and potential candidates Manage respective candidate pools to ensure qualified candidates remain engaged in current or future opportunities Administer and submit all hiring paperwork for new employees Communicate regularly with HR department to get a clear view of company's hiring needs and organizational goals Proactively seek market intelligence to gain competitive advantage in attraction, assessment and sourcing methodologies Suggest new ideas for improving talent acquisition activities Research talent acquisition trends in the staffing industry

Biocon Biologics is a fully integrated pure play biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's rst publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe. Experience : 5 - 8 years Educational Qualification : MSc / MPharma / MTech Role & responsibilities The person would be an individual contributor with a strong background in analytical science / quality control for Biologics with a focus on Physicochemical Analytics. Hands on experience in biochemical analytical techniques covering a range of analytical assays, including HPLC (High Pressure Liquid Chromatography), CE-SDS (Capillary Electrophoresis sodium dodecyl sulphate), iEF (Isoelectric focussing) and UV Spectroscopy. Designing experimental plans, writing study protocols, reports, execution of studies and data evaluation. Basic knowledge of documentation practices in a GMP environment, OOS and route cause investigations. Should be versed with analytical method validation, method transfer and compendial method verification. Act as SPOC representing ASAT during cross functional interactions.

We are seeking a highly motivated and detail-oriented Graphic Designer to join our Biocon Team. Biocon Group - Centre of Excellence is a hub for innovation and excellence, driving impactful projects in the pharmaceutical and biotechnology sectors. We are looking for a talented Graphic Designer to join our team and contribute to our digital and visual communication efforts. The ideal candidate will have a strong portfolio demonstrating a solid understanding of design principles, visual storytelling, and brand consistency. You will work closely with cross-functional teams to identify business needs, design solutions, and drive change. KEY RESPONSIBILITIES Design engaging graphics, illustrations, and layouts for digital and print media. Create visual content for social media, websites, newsletters, presentations, and marketing materials. Develop infographics, brochures, reports, and posters to communicate complex information effectively. Assist in video editing and motion graphics creation as needed. Collaborate with the marketing and communications team to align visual content with brand guidelines. Support the development of internal and external branding materials. Stay updated with industry trends and bring fresh, creative ideas to the table. WHAT WE OFFER 1.Opportunity to work with a leading pharmaceutical company. 2.Exposure to a dynamic and innovative work environment. 3.Opportunity to contribute on impactful projects 4.Professional development and networking opportunities. REQUIREMENTS: Educational Background: Bachelors degree such as B.Sc. in Multimedia & Animation, B.Sc. in Visual Communication, B.A. in Graphic Design, B.Des. in Communication Design, BFA, or a related field. Preferred: 2 - 3 years of professional experience in graphic design. Technical Skills: Proficiency in Adobe Creative Suite (Photoshop, Illustrator, InDesign, Premiere Pro, After Effects), Canva or equivalent design tools. Strong portfolio showcasing design and content creation skills. Understanding of design principles: typography, layout, color theory, and branding. Experience in motion graphics, video editing, or animation. Soft Skills: 1.Strong analytical, problem-solving, and communication skills. 2.Ability to work collaboratively in a fast-paced environment. 3.Excellent attention to detail and a creative mindset. 4.Excellent time-management skills Note: This is an Full time contract role, Apply only interested. Selected & Interviewed only if the Resume & Portfolio attached.

Seeking aspirants for Apprenticeship: We are looking fresh graduates interested in gaining practical experience in a biotechnology plant environment. Required Qualification : •B.E / BTech/M.Tech (Chemical, Electrical, Electronics, Instrumentation, Automation, Mechanical, Mechatronics, Biotechnology, Biochemistry) MSc, BSc, B Pharm (Biotechnology, Microbiology, Life Science, Biochemistry) • Years of Graduation 2024 & 2025 (We are currently looking for freshers, not experienced candidates.) Departments: Manufacturing - Plant Operations, Engineering - Utility Maintenance and Plant Operations We are currently looking for candidates who are willing to work in production function in Biotechnology plant setup. Candidates should be prepared to in scheduled shift basis operations.

At least 8 years of consulting experience in SAP IBP S&OP, DP, Response Planning & Control tower. Having knowledge in Order Based Planning is an added advantage Should possess 2 Supply Chain IBP End-to End Implementation Deep knowledge and business process experience with SAP IBP (Integrated Business Planning) solutions Experience in Integrating SAP ECC / S/4 HANA with IBP using CI-DS & RTI. Should be able to drive business blueprint workshop with supply chain stakeholders and ability to decipher business requirements into IBP solutions. Ability to define SoP for IBP planning optimizers. Troubleshoot all the ongoing issues and provide resolutions to restore business continuity Extensively collaborate with Business and other IT team for the tasks that are assigned, add value to the project and deliverables.

At least 8 years of consulting experience in SAP IBP S&OP, DP, Response Planning & Control tower. Having knowledge in Order Based Planning is an added advantage Should possess 2 Supply Chain IBP End-to End Implementation Deep knowledge and business process experience with SAP IBP (Integrated Business Planning) solutions Experience in Integrating SAP ECC / S/4 HANA with IBP using CI-DS & RTI. Should be able to drive business blueprint workshop with supply chain stakeholders and ability to decipher business requirements into IBP solutions. Ability to define SoP for IBP planning optimizers. Troubleshoot all the ongoing issues and provide resolutions to restore business continuity Extensively collaborate with Business and other IT team for the tasks that are assigned, add value to the project and deliverables.

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives. Key Responsibilities: Implementation of LabWare LIMS Design and configuration of LIMS Process flows, Reports, etc., Installation of new modules, maintenance releases, configuration packages and lab tracks Integration with SAP (Bi-directional) and Instruments (RS232) Creation/Modification of Subroutines, Menu Routine, Automation scripts, Events, Status rule, Access Routines, Query tags, Folder templates, Sample login templates, Stored Query manager, Crystal reports, Visual Workflows, Label formats, Table templates, Lot templates, Inventory templates, Stability Protocol templates, Project templates, Analysis calculations, etc., Configuring Background server schedules Having knowledge in Empower 3 user profile and user group Creation/Modification, Message center backup, Project Backup and Restoration. Qualifications and Requirements: Bachelor's degree in a related field (Computer Science, Information Technology) or equivalent experience. Expertise of having minimum of 8+ years into Labware (or related) LIMS implementation exposure Proficiency in managing licenses and maintaining compliance. Excellent problem-solving and troubleshooting skills. Strong communication and interpersonal skills. Ability to work independently and as part of a team. Strong communication and coordination skills. Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act.

At BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. We have 6500 people across the world innovating, creating, and delivering quality healthcare collaboratively, while employing the highest levels of ethics and integrity, every day. We have been listed in the Top 10 Bio-Pharma Companies to Work For more than once by Science Magazine, including this year. KEY RESPONSIBILITIES The incumbent will work closely with the Corporate Quality Assurance teams under the supervision of the Digital Business Partner, leading articulation of key technology and digital requirements and ensuring successful rollouts. More specifically s/he will lead the following responsibilities: Business Analysis: Point of contact and between business, IT, end user and other cross functional teams during the project or maintenance phase. Collect data, analyse & define the business and user requirements. Analyse business problems and facilitate in IT solution evaluation. Work closely with managers and end users to have buy-in for the proposed solution. Creating a detailed business analysis, outlining problems, opportunities, and solutions for the business users and stakeholders. Categorize the functional and non-functional requirements of the business. Conduct post project implementation acceptance and requirements reviews. Perform additional tasks as assigned by the reporting manager, time-to-time basis in DevOps mode. Prepare validation documentation related to release of GxP system. Should have sound knowledge on preparing validation artifacts for GxP IT systems. Should have knowledge of GxP system testing and validation. Sound communication skill with good amount of convincing power (intermediate level). An ideal candidate should be well planned and structured in his/her all deliverables. Must have experience in Pharma IT with hands-on expertise for handling GxP systems. IT Support and Maintenance: Provide IT administrative support for Enterprise systems but not limited to the following mostly focusing on L1 and L2 support for Veeva Vault QMS. Coordination with OEM partners for L3 support. User Management (Creation, Modification, Password reset etc.). User Access Rights Management. Active user list preparation. Support to Biocon users on the enterprise application on service requests, incidents and bug fixes. Periodic review of event logs (as where applicable). Provide support to vendor for fixing IT related issues during breakdowns. Responsible for adoption, creation and Maintenance of Quality Management Procedures as per IT Operation requirements. 1st level Point of Contact for all IT related queries from Biocon users for enterprise systems Co-ordination with Enterprise functional Team for finding the RCA from IT Perspective in their Incidents and CAPAs. Responsible for implement Change controls and log Incidents and deviation related to IT Functions. Responsible for adherence of SLA’s defined for various IT administrative support activities. PROFESSIONAL EXPERIENCE / QUALIFICATIONS Bachelor’s in Engineering or Master’s degree in a related discipline, including a minimum of 2-4 years of experience gained in technology implementation in the Pharma space Specific experience as a Business Analyst in a GxP application for a pharma company Veeva QMS administration experience – preferably with Veeva certification. Excellent oral/ written communication skills Self-starter, with the ability to work and execute independently with minimal oversight. Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act.

Molecular Biology activities like plasmid and genomic DNA preparation, PCR amplification, restriction digestion, molecular cloning, sequence confirmation, involved in vector construction for stable and transient gene expression. Routine cell bank preparation of microbial and mammalian cells. Analytical skills related to protein estimation and characterization like, ELISA, SDS PAGE/Western Blot, Octet and HPLC. Standard cell culture activity such as vial thaw, subculturing, transfection, single cell cloning, fed batch, monoclonality assurance. Experience in bacterial and yeast expression systems preferred. Routine documentation in electronic notebook. Preparation of SOP/GM and development reports. Industrial experience of 4-6 years in cell line development.

Verification and Validation R&D Primary responsibilities: Represent the Design Quality function on device development project teams and cross functional co-ordination with multiple departments including R&D, Quality Control, Manufacturing and Regulatory Affairs. Ensure that device development projects and changes to existing devices are conducted in compliance with the FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, and other applicable standards like ISO 14971. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified. Lead or support design activities including design verification, validation, test procedure development, usability engineering, and risk management. Generate or apply statistical methods with appropriate risk-based justification. Hands-on experience in Design History File compilation / Technical file documentation. Support internal and external inspections/ regulatory audits. Promote continuous improvement in design control activities and use of quality tools with design team. In-depth knowledge and understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Secondary responsibilities (Wherever applicable): Experience interacting with regulatory agencies and notified bodies Experience with process improvements, process qualification and validation. Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.