1749 Gmp Jobs - Page 8

Career Category Information Systems Job Description Let s do this. Let s change the world. In this vital role you will have a proven track record of leadership in technology-driven environments using 3DEXPERIENCE Cloud SaaS platform and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Maintain strategic relationships and strong communication with the leadership team about IS services and service roadmaps to ensure that all the collaborators feel informed and engaged Lead and manage diverse team within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US and other international locations. Develop a culture of collaboration, innovation, and continuous improvement. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Responsible for handling, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Understand the decision-making process, workflows, and business and information needs of business partners and collaborators Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met Ensure communication of key performance metrics and analysis of unmet needs Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Facilitate best practice sharing, ensuring ongoing alignment with the Technology & Digital strategy Provide education to new partners with regards to IT service offerings Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years experience in Business, Engineering, IT or related field Preferred Qualifications: Must-Have Skills: Strategize, plan, and implement various phases of PLM roadmap with a clear focus on eliminating manual workflows, streamlined process, and enabling digital thread using Dassault Systemes 3DEXPERIENCE platform and integrating with key enterprise platforms Strong Technical/Functional experience solutioning and supporting GMP applications across Engineering, Clinical, Commercial and Quality functions. Demonstrated hands-on experience in managing technology solutions involving ENOVIA, DELMIA, CATIA Report Generator, NETVIBES, EKL, and OTScript in a SaaS environment. Strong hand-on experience with configuring and customizing solutions for Requirements, CAD, EBOM, MBOM, Configuration/Variants, Recipe, MPP, Risk, Document and Change management. Must have led multiple data migration from various sources to 3DEXPERIENCE platforms. Must have experience in creating solutions using Enterprise Integration Framework to integrate with enterprise systems such as Enterprise Data Fabric, Veeva vault, SAP, MES systems. Must be familiar with middleware systems such as Mulesoft, Boomi or Tibco. Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Exceptional collaboration, communication and interpersonal skills to effectively manage collaborator relationships and build new partnerships. Experience in applying technology standard process methodologies using Scaled Agile (SAFe). Good-to-Have Skills: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business stakeholders Broad working knowledge of key IS domains and layers Professional Certifications: Scaled Agile Framework (SAFe) for Teams (preferred) Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta. Develop and maintain comprehensive test plans for 3DExperience platform modules and application Contribute actively to release planning and estimate test efforts Test in an Agile development environment, analyze and communicate test results to team and manager Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), Validation Reports, deviations, change control, and non-conformance management. Assist with UAT, test data preparation and developing work instructions. Develop and execute automated test suites across various modules in 3DEXPERIENCE. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with cross-functional teams, including quality assurance, product owners, business owners to execute validation activities and meet project deadlines. Work closely with manager to ensure timely and effective completion of all validation activities in line with project objectives and schedules. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams and Dassault to pursue issue resolution. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelor s degree and 2 to 6 years experience in Software Quality and GMP Validation Preferred Qualifications: Functional Skills: Must-Have Skills: Experience in Quality Assurance (QA) testing with at least 3 years of experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions. Experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). Overall experience in developing, executing and analyzing QA & Test Automation Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Experience with computer system validation and software validation. Strong problem-solving and analytical skills. Good-to-Have Skills: Understanding of 3DExperience platform architecture, modules, and integration points is highly desirable Experience with automated and computer-controlled systems validation (21 CFR Part 11) Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

We are seeking a highly motivated and experienced Product Owner/Business Analyst/Subject Matter Expert to lead the development and enhancement of our Laboratory Information Management System (LIMS). This role will be responsible for defining and prioritizing product requirements, translating business needs into technical specifications, and ensuring the LIMS effectively supports our laboratory operations. The ideal candidate will possess a deep understanding of laboratory workflows, data management principles, and regulatory requirements within the [Specific Industry - e.g., Pharmaceutical, Biotech, Environmental Testing] industry. This is a hybrid role requiring a combination of product ownership, business analysis, and subject matter expertise. **Responsibilities:** * Define and maintain the product vision, strategy, and roadmap for the LIMS. * Prioritize and manage the product backlog, ensuring alignment with business goals and user needs. * Act as the primary point of contact for the LIMS product, representing the voice of the customer and stakeholders. * Collaborate with development teams to ensure successful product delivery. * Participate in sprint planning, daily stand-ups, sprint reviews, and retrospectives. * Translate business requirements into clear and concise user stories, acceptance criteria, and functional specifications. * Create process flows, use case diagrams, and other visual aids to communicate requirements effectively. * Conduct gap analysis to identify discrepancies between current and desired LIMS functionality. * Assist with user acceptance testing (UAT) and provide support to end-users * Serve as a subject matter expert on LIMS functionality, data management, and industry best practices. * Provide guidance and support to users on LIMS workflows and data entry procedures. * Stay up-to-date on industry trends and emerging technologies related to LIMS. * Participate in the evaluation and selection of new LIMS modules or enhancements. * Ensure the LIMS complies with relevant regulatory requirements, such as [e.g., FDA 21 CFR Part 11, GLP, GMP]. * Develop and deliver training materials and documentation for LIMS users. * Configure and customize the LIMS system to meet specific laboratory needs. 1. The Software Engineering Leader oversees and guides teams to deliver high-quality software solutions aligned with organizational goals and industry best practices.2. Is a professional in technology, proficient in strategic planning, decision-making, and mentoring, with an extensive background in software development and leadership.3. Is typically responsible for setting the strategic direction of software development efforts, managing project portfolios, and ensuring effective execution of software engineering initiatives to meet organizational objectives.4. Builds skills and expertise in leadership, staying abreast of industry trends, and cultivating a collaborative and high-performance culture within the software engineering team.5. Collaborates and acts as a team player with cross-functional teams, executives, and stakeholders, fostering a positive and productive environment for successful software development initiatives. Job Description - Grade Specific Skills (competencies) Verbal Communication

Summary As a key resource within the Audit Management Office (AMO), this role ensures effective coordination and management of audits and inspections involving Data, Digital & IT (DD&IT) systems and processes. This includes supporting GxP audits (e. g. , GMP, GCP) and regulatory inspections by authorities such as FDA, EMA, MHRA and Swissmedic. The associate acts as a liaison, ensuring that relevant DD&IT subject matter experts address audit queries and deliver required documentation in a timely and accurate manner. Additionally, the role involves monitoring audit findings, overseeing remediations, and driving continuous improvement in audit readiness. About the Role MAJOR ACCOUNTABILITIES Govern processes to effectively manage both internal and external audits across Data, Digital & IT (DD&IT), focusing on GxP (e. g. , GMP, GCP), quality, and regulatory-related audits, along with stakeholder management, remediation tracking, status reporting, and lessons-learned sharing. Act as the single point of contact (SPOC) for audit teams across DD&IT, coordinating audit and inspection activities, ensuring effective communication, and maintaining compliance throughout the process. Notify and mobilize relevant DD&IT stakeholders such as application managers, system owners, QA, Information Security & Compliance (ISC), and SOP process owners for audits and inspections, ensuring timely readiness. Coordinate globally with business teams to ensure audit support tickets are created, tracked, and resolved in alignment with Novartis policies and procedures. Conduct pre-audit meetings to clarify IT scope, agree on auditor pre-requests, align timelines, and ensure stakeholders understand expectations for audits and inspections. Provide advice and guidance to DD&IT teams on GxP and information systems compliance requirements to ensure alignment with regulatory standards such as FDA, EMA, MHRA and Swissmedic expectations. Track and proactively manage audit requests across different time zones, ensuring SMEs respond on time, identifying backups where needed, and escalating delays or deviations as appropriate. Guide DD&IT SMEs by clarifying audit process requirements and supporting them throughout the audit lifecycle, ensuring accurate delivery of requested information. Conduct training sessions on audit readiness, including proper inspection etiquette and effective collaboration during audits and inspections. Collaborate with internal teams to improve and standardize governance frameworks and processes, aiming to reduce audit findings and improve inspection readiness. Escalate compliance deviations and critical quality issues to senior management and coordinate resolution efforts, ensuring corrective and preventive actions (CAPAs) are implemented effectively. Manage relationships at a global level across divisions and functions, including ISC, e-Compliance, and DDIT teams, facilitating cross-functional alignment and collaboration on audit-related matters. Coordinate and participate in audit closing meetings, preparing summaries of findings, tracking observations, and supporting SMEs in addressing them. Partner with security, compliance, and quality experts to identify focus areas, evaluate industry trends, and recommend strategies to improve audit processes and outcomes. Monitor and report on audit findings, remediation actions, and related improvement activities, ensuring compliance, security, and quality gaps are addressed thoroughly. Drive and coordinate key Sarbanes-Oxley (SOX) activities in collaboration with application teams and external auditors, ensuring alignment to SOX IT controls and timely delivery of evidence while minimizing audit-related disruptions. Ensure adherence to security and compliance policies and procedures within the audit management governance framework, while aligning with internal and external quality standards. Minimum Requirements University degree or equivalent. Master s degree in IT, Quality Management, Business Administration, or related fields. Overall 8-10 years of work experience in quality management, audit, and compliance within IT, preferably in a global organization. Experience in the pharmaceutical industry or other regulated industries, with knowledge of GxP processes and compliance requirements. In-depth understanding of pharma business processes and their interrelationship with IT systems and regulatory frameworks. Proven track record of managing audits, regulatory inspections, and remediation efforts in pharma or other highly regulated environments. Experince with Computer System Validation (CSV), system testing, and adherence to lifecycle validation processes (e. g. , requirements gathering, system design, validation testing, implementation, and maintenance). Knowledge of ITIL processes and best practices. Demonstrated ability to work effectively in large, cross-functional, global organizations. Proficient in Excel, PowerPoint, and other productivity tools for reporting and presentation. Business-proficient in English (written and spoken). Strong communication skills with the ability to articulate expectations and audit requirements clearly to diverse teams and stakeholders. Ability to manage multiple priorities and time-sensitive processes efficiently. ITIL-certified professional. Strong knowledge of validation practices, including GxP, Sarbanes-Oxley (SOX), and pharmaceutical quality compliance standards. understanding of CSV lifecycle processes, including risk assessment, traceability matrix development, protocol execution, and impact analysis. Business knowledge or experience in IT s role supporting audit and compliance functions within regulated industries. Expertise in Computer System Validation (CSV) testing methodologies and frameworks. ? Our purpose is to reimagine medicine to improve and extend people s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www. novartis. com / about / strategy / people-and-culture Commitment to Diversity and Inclusion: Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Summary The Global Change Control Manager oversees the entire process of managing GxP-impacting changes within the global manufacturing network. This role is responsible for the change control process from initiation, through impact assessment, planning, execution tracking, documentation, CAPA effectiveness, continuous improvement in change governance, and metrics reporting. The manager works closely with cross-functional teams such as Regulatory, Quality, Operations, to support timely implementation, risk management, and ongoing improvement in change governance. The role also contributes to audits, inspections as well. About the Role Key Responsibilities: Good Understanding of Global Change control process and able to advice on Global and Local Change request strategy. Align between sites and Regulatory team regarding Change control plan, impact / implementation on sites. Prepare the change request plans and present them for endorsement at the Change review board (CRB) Open global change requests, assign impact assessment actions, and manage the lifecycle of Change Requests (CR). Track and report the implementation status of change requests with cross-functional teams. Manage and maintain change control documentation, including updates, version control, and compliance with cGMP and regulatory standards. Facilitate change control review meetings, capturing key information and translating it into actionable and clear documentation. Provide support during audits and inspections by ensuring accurate and readily available change control documentation. Collaborate with cross-functional teams (Quality, Operations, Engineering) for accurate documentation. Track and report metrics related to documentation timeliness, compliance, and quality. Comply with internal processes like KPI reporting, ticket management, and functional requirements. Contribute to process improvement initiatives by identifying and addressing gaps in change control documentation workflows. Support and contribute to quality management system (QMS) actions such as Change Controls, CAPA, effectiveness checks (EC), risk assessments, and OOXs management. Participate in periodic QMS reviews to identify and contribute to areas of improvement where applicable. Good Understanding of Process/Cleaning Validation and Technology transfer concepts and requirements including transfer protocols, validation protocols & reporting and comparability reports Collaborate with site teams for Transport Validation / Shipping verification activities including validation risk assessment, testing protocols and reports. Act as SPOC to drive key Global projects within the platform and collaborate with sites to ensure timely execution of tasks/ deliverables Desirable Requirements: Bachelors/Master degree in Pharmacy, Pharmaceutical Technology, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience. Good understanding of Radio Ligand Therapies (RLT) platform Minimum 10 years of experience in MS&T, Quality Assurance in Manufacturing of Biologics Drug substance and Drug Product. Hands on experience in 1-QEM tool. Strong understanding of Global change control processes, cGMP, and regulatory requirements Proven project management experience in a cross-functional environment (e. g. multi-site, technical development, other functions). PMP is added advantage. Expertise in document management system and writing technical reports Experience in Health authority audits and Self inspections. Good communication, presentation and Interpersonal skills. Proficiency in English (oral and written) is mandatory. Essential Requirements: Quality / Accuracy / Right First Time Quality System Management (Change Control, CAPA, Risk Assessment and EC) Support Accuracy and compliance of change control documentation Timeliness of documentation updates and approvals Stakeholder satisfaction with documentation quality and usability Adherence to regulatory requirements during audits and inspections Effectiveness of standardized documentation processes Skills: Change Control Process Effective communicator Strong cross functional collaboration Biologics Manufacturing Process Project Management Good Documentation Practice Effective stakeholder engagement Report writing Knowledge Of GMP (Good Manufacturing Practices) Deviation management Corrective and preventive action (CAPA) General HSE Knowledge Manufacturing (Production) Manufacturing Technologies. Process And Cleaning Validation Why Novartis: Commitment to Diversity and Inclusion: . Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Responsibilities: Manage CSV projects from start to finish. Ensure compliance with GAMP, GDP, CapA, GXP, IT Compliance & LIMS standards. Collaborate with cross-functional teams on system validation. Free meal Cafeteria Food allowance Shift allowance Over time allowance Travel allowance Sales incentives Annual bonus Performance bonus Marriage & childbirth gifts

A Production Pharmacist oversees the manufacturing process of pharmaceuticals, ensuring quality, safety, and compliance with regulations. They manage the production line, monitor processes, conduct quality control, and ensure adherence to Good Manufacturing Practices (GMP). This role also involves planning and coordinating production activities, troubleshooting issues, and potentially developing new products or processes. Here's a more detailed breakdown: Key Responsibilities: Supervision and Management: Overseeing the entire production process, from raw materials to finished products, ensuring adherence to quality standards and production targets. Quality Control: Implementing and maintaining quality control procedures, conducting regular inspections, testing, and validation of equipment, processes, and products. Compliance: Ensuring compliance with all relevant pharmaceutical regulations, including GMP, and maintaining accurate production records and documentation. Production Planning: Developing and optimizing production plans, scheduling activities to meet deadlines and targets. Troubleshooting and Problem-Solving: Identifying and resolving any issues that arise during the production process. Collaboration: Working closely with other teams, such as quality assurance, quality control, and production staff, to ensure smooth and efficient production. Training and Supervision: Training and supervising production staff, ensuring they understand and follow procedures and safety guidelines.

Preparing, Reviewing and Submitting Product Dossiers as per Country Specific guidelines Preparing, Reviewing and Submitting Renewal Dossiers / Variations. Responding to queries raised by Regulatory authority of respective country. Preparing CAPA reports for the audit or market complaints. Coordinating with various department for Technical Documents as DMF, Stability data, FP COA, API COA, etc. Coordinating & Arranging for the registration samples as per country guideline. Reviewing & Approving the Artworks (Text Content) Coordinating with FDCA Person for COPP & GMP and its legalization process. Updating all registration status records. Maintaining Retain Samples Records. Coordinating with customer for filing of dossier & getting it timely approval. SKILLS: Fluent in English. Good communication skills. Ability to work under pressure and to meet deadlines.

Should be capable of handling wet analysis like LOD, Ash content, Moisture content analysis etc Should have the knowledge of instrumentation analysis like HPLC , GC , IR , UV , Titrator etc,, Should have knowledge of GLP , GDP and GMP

Should be capable of handling instrument like HPLC, GC , UV, IR and potentiometry Should have the GMP knowledge and compliance requirement of QC Should have the knowledge on Good laboratory practices .

ROLES & RESPONSIBILITY Oversee the daily operations of the raw material store, ensuring proper storage, labeling, and handling practices are followed. Maintain accurate inventory records of all raw materials, including batch numbers, expiry dates, and storage conditions. Supervise the receipt of incoming raw materials, ensuring quality checks, GRN generation, and documentation are completed. Ensure materials are stored as per predefined environmental and safety standards (e.g., temperature, humidity, segregation). Coordinate with the Quality Control (QC) and Quality Assurance (QA) departments for material clearance and release for production. Implement FIFO/FEFO principles and monitor stock movement to prevent material expiry or obsolescence. Conduct regular cycle counts and support full physical stock audits. Maintain documentation in compliance with ISO 13485, GMP, and company SOPs. Ensure timely issuance of materials to production based on requisitions and maintain issue records. Train and supervise store personnel, ensuring adherence to company procedures and safety protocols. Coordinate with procurement and planning teams for material availability and shortage alerts. Manage store cleanliness, pest control activities, and overall hygiene as per QMS requirements. Qualifications and Skills: Bachelor s degree in Science, Pharmacy, Supply Chain, or related field (preferred). 10+ years of experience in inventory/store management in a manufacturing or medical device company. Strong knowledge of material handling, warehousing systems, and ERP software. Familiarity with ISO 13485, GMP, and regulatory requirements related to raw material handling. Excellent organizational, communication, and problem-solving skills. Attention to detail and commitment to documentation accuracy. Key Competencies: Inventory Management Regulatory Compliance Documentation Accuracy ERP and Barcode Systems Team Management Coordination & Communication Quality Awareness Problem Solving

Role & responsibilities Position: Manager/ Sr. Manager Qualification : B.E / B. Tech (pref. Chemical eng) / M.Sc Additional qualifications: MBA or Diploma in Material Management. No: of years: 8 - 10years Industry: Bio pharma/ Pharma / Pharma Area of Experience: Planning & Procurement or RM, PM and R &D items. Procurement of services. Familiarity with Vendor Qualification procedure in GMP environment Familiarity with PPIC Good Negotiation Skills ( As Volume of procurement is high) ERP: Experience in MM module (SAP) Preferred candidate profile

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines received from client/agency. Preparation of check list as per country specific requirements region. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. Filing of variations if any and registration renewals. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Maintaining the product status (Registered and Under registration) in excel sheet. Desired Candidate Profile Should Have Regulatory Affairs Relevant Formulation Experience Perks and Benefits

Client consultation and coordination on calls and emails Understanding the requirements of the clients and guiding them Sending quotations of Visa requirements and taking follow ups Verification of the documents required for the Visa and resolving the queries of the clients if any Processing the visa applications Coordination with the embassy/consulates Documentation Follow-ups

The ideal candidate will bring in-depth experience in pharma warehouse operations, with a proven track record of managing large-scale warehouse functions efficiently.

Pre-preparation for Customer Key Handover as per SOP. Generate rapport with the customers coming for Key Handover Demonstrate a high degree of warmth while dealing with / talking to the customers Register all customer feedback/concerns and channelize it as per SOP in order to close the loop. Maintain Customer data confidentiality. Any other activity associated with Customer Engagements/ Events - assist in these

JOB/ROLE DESCRIPTION The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Key Responsibilities At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit. Compliance with safety policy and procedures: Facilitate and monitor the performance of regular facility walkthroughs and internal quality audits for biologics operations to ensure adherence to the implemented systems and compliance with regulatory requirements including data integrity assessment. Responsibility for establishment and implementation of a robust cleaning, sanitization & sterilization process. Monitoring of equipments which are related to Facility Management and responsible for review of logbooks and reports. Lead and monitor management of garments and general consumables as per BMP5 facility requirements. Review the SOP s, protocols, study reports procedures in BMP5 operations. Lead and monitor timely tracking of Operational and Compliance Metrics for manufacturing Operations and management reporting. Facilitate and monitor the implementation of the approved CAPA for the Biologics Operations in Facility Management section. Facilitate and monitor waste management as per the established procedures and adherence to the Clean Room Behavior by all the personnel working in the clean rooms. Leading the team in effective manner. Leading the commissioning and qualification & requalification of all equipment s which are related to facility management. Support for timely reporting of deviations, appropriate investigations to identify the root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence. Support for appropriate manufacturing investigations for OOS and results and customer complaint to identify the root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence. Support for risk management for biologics operations (Facility Department) which covers the following elements and ensured proposal and implementation of appropriate risk mitigation actions (CAPA). Quality and Compliance Risks Operational Risks Data Integrity Risks Facilitate and monitor timely preparation, review, and approval of GMP Documentation for BMP5 Facility Management related major equipment s. Standard Operating Procedures (EOP, IOP and SOP). Protocols and Reports Any other GMP relevant documentation. Support for control of documents and records within the Manufacturing Operations. Execution of BMP5 facility related activities by adhering to Syngene s safety and GMP practices. Other competencies required for the role Follow the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment and adhere to the highest standards of quality, integrity & compliance for every work activity. Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar. Attend all assigned mandatory trainings related to data integrity, health, and safety measures. Compliance to Current Good Manufacturing Practices and Good Documentation Practices. Adherence to Standard Operating procedures, Operational control Procedures. Participate in & support the trainings on procedures, protocols, and On-the-Job activities. Follow the discipline of reporting structure at times of escalation. Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s). Participate in & support for on-time initiation & closure of deviations, investigations, CAPA and change controls. Safety and DI Responsibilities: Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security. Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety. Understand all necessary safety protocols and always follow the same to ensure safety for all. Proactively identify near-misses & potential incidents and communicate to supervisor and/or line manager or through the respective web portals. Equal Opportunity Employer . Pls visit us at https://syngeneintl.com/ to know more about us and what we do.

Lodha Group is looking for Data Analyst (Pre-Sales) to join our dynamic team and embark on a rewarding career journey Managing master data, including creation, updates, and deletion. Managing users and user roles. Provide quality assurance of imported data, working with quality assurance analysts if necessary. Commissioning and decommissioning of data sets. Processing confidential data and information according to guidelines. Helping develop reports and analysis. Managing and designing the reporting environment, including data sources, security, and metadata. Supporting the data warehouse in identifying and revising reporting requirements. Supporting initiatives for data integrity and normalization. Assessing tests and implementing new or upgraded software and assisting with strategic decisions on new systems. Generating reports from single or multiple systems. Troubleshooting the reporting database environment and reports. Evaluating changes and updates to source production systems. Training end-users on new reports and dashboards. Providing technical expertise in data storage structures, data mining, and data cleansing.

Position: Technician Engineering Grade: Technician No. of Position: 8 No. Job Location: Ahmednagar Qualification: ITI (MMCP) Experience: 2-7 yrs experience in API manufacturing plant Job Profile Equipment Maintenance and Troubleshooting : Maintaining and repairing manufacturing equipment, including performing preventative and corrective maintenance, and troubleshooting issues to minimize downtime . Process Support: Providing technical support for the API manufacturing process, ensuring smooth operation and adherence to established procedures. Quality and Safety Compliance: Ensuring all work is performed in accordance with GMP (Good Manufacturing Practices) and other relevant quality and safety standards. Documentation and Record Keeping: Maintaining accurate records of maintenance activities, equipment performance, and any deviations from standard procedures. Breakdown Maintenance: Attending Breakdown maintenance as and when required .

Job Summary: We are looking for an experienced professional to manage and validate GxP computerized systems in a regulated pharmaceutical environment. The ideal candidate will play a key role in ensuring IT compliance with industry regulations and supporting core Quality Management System activities. Key Responsibilities: Installation and configuration of operating systems and other applications Diagnosing and troubleshooting of computer system and software problems Maintain an inventory of GxP computerized systems. Preparation and implementation of all the IT procedures as per GMP requirements. Responsible for Electronic data backup, archival and restoration. Verification of daily backup for electronic data generated for instruments. User management (Creation / modification of User IDs and passwords, assigning privileges) for laboratory and GMP Softwares. Developing the validation deliverables for computerized systems used in GLP, GMP and GCP environments. (Manufacturing and Laboratory Systems) Preparation, execution and reporting of GxP computerized systems validation deliverables Maintain the validated state of all GxP computerized systems Conduct periodic reviews of all GxP computerized systems to ensure continued compliance. Manage QMS activities to ensure timely completion of action items, including Change Controls, Deviations, investigations, and CAPAs. Review protocols, QMS documents, CSV deliverables, and other related documents to ensure accuracy and compliance. Good knowledge of GMP, 21 CFR Part 11, Annex 11, GAMP 5, Data Integrity requirements for Pharma Required Skills & Experience: 3-4 years in Pharma industry Strong working knowledge of GMP, 21 CFR Part 11, Annex 11, and GAMP 5 Hands-on experience in validation of GxP systems within a pharma or life sciences setup Solid understanding of pharmaceutical regulatory and compliance frameworks Educational Qualification: M.Sc / B.E / B.Tech / MCA (with relevant industry experience)

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary To ensure planning and monitoring of analytical activities, Instrument Calibration / Qualification, Investigations and Documentation as per the procedure in Quality control at Apotex Research Pvt. Ltd. Job Responsibilities Report to Head of Quality & Compliance regarding day to day activities to Head, Quality Control. Ensure the operations in Quality Control Laboratory as per the established standard procedure. Identify the departmental employees training needs and to fulfil the same. Provide support to Manufacturing Operations during the execution of exhibit batches / commercial batches within the stipulated time line. Assess, review, approval and ensure the timely completion of the changes in QC department as per established & approved change control procedure. Ensure timely completion of analysis of commercial samples. Ensure smooth functioning of all laboratory instruments in co-ordination with service engineers. Responsible for reviewing and approval SOP s and directions for testing of laboratory samples in QC. Perform all work in accordance with all established regulatory and compliance and safety requirements. Conduct investigation for OOS / OOT results, and to identify assignable cause wherever applicable and to ensure timely completion of laboratory analytical investigations. Evaluation of Investigation, Deviations, CAPA and Change Control Records and approval as Manager Approval . Ensure a disciplined work environment and to provide expertise to subordinate \ colleagues in proper performance of laboratory procedures. Interact with QA department / Auditor during inspections or any audit conducted by regulatory authorities. Assist Quality group in various activities like data compilation for APQR, Training, Vendor development programme, Self-inspection and External audit programme. Participate in handling of Market complaints / Product recalls / Quality related returns (if any) in co-ordination with Quality group at Apotex affiliates and responding the same if required. Ensure to update (self) with latest cGMP / GLP / Regulatory requirements and to train the same to the departmental people. Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees. Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values Collaboration, Courage, Perseverance and Passion. Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process. Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures. Take up any other work allotted by seniors and to fulfil the same. Job Requirements Education Minimum MSc /B Pharma or any equivalent degree. Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonnel skills. Proficient in MS office tools. Knowledge on preparation and review of various documents like SOPs, formats, protocols, reports and analytical data etc. Knowledge on investigation and deviation report preparation. Having good command on trouble shooting on instrument and analysis. Having well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities. Able to priortise the task, best in effective planning of work activities to meet the timelines. Experience Minimum 16 to 20+ years of experience in GMP regulated Pharmaceutical industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary To Manage the entire qualification and validation activities in the site specifically related to equipment/utility qualification, cleaning validation, process validation, packaging validation and perform the activities in compliance with the various regulatory guidelines and standards. To monitor regular activities related to quality validation and engineering as per established procedures. Job Responsibilities Review and approval of documents pertaining to equipment/utility qualification, cleaning validation, process validation, hold time studies and packaging validation. Approval of layouts, yearly & monthly schedules, to be added planners. SME for Qualifications and Validations during Regulatory audits and ensuring compliance to regulatory requirements. Assess change controls related facility, equipment, process, utility, cleaning and packaging. Review & approve of standard operating procedures. Co-ordination and implementation of training activities of team members. Responsible for review of site VMP s (Validation Master Plan) and related documents. Responsible for review and approval of process validation & cleaning validation protcolsand reports. Co-ordinate with cross functional teams in Investigations carried out at ARPL. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion, Demonstrates strong and visible support of our values. Performs all work in accordance with all established regulatory and compliance and safety requirements. All other duties as assigned as per the expertise in the relevant subject. Job Requirements Education Minimum Bachelor of Pharmacy/ Science or any equivalent degree. Knowledge, Skills and Abilities Possess sound knowledge in Qualification and Validation of Equipment, Facility, Utilities, Process and Cleaning Maintains good Interpersonal skills and communication skills. Strives to drive projects related to Validations & Engineering effectively. Experience Minimum 12 - 15 years of experience in GMP Regulated pharmaceutical industry At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for Stability Management Activity, Documentation and Training coordination. Initiate and evaluate various investigations and excursions as per SOP. Review of data, Documents, SOP, Specifications, Protocols and Reports wherever applicable. Responsible for all stability Management activities. Job Responsibilities Planning of stability samples to be charged. To ensure the smooth general day-to-day functioning of the Team activities. Review of Stability Protocols. Review of LIMS parameter in the stability projects for revised test profile (as applicable). Updation and authorization stability tracker entries. Review of inventory, chamber cleaning, stability reserve samples, chamber events logbooks, verification for completeness of stability samples receipt logbook etc. Review of Monthly Withdrawal Schedule. Ensuring the stability terminated samples disposition. To review various documents like Standard operating procedures, Formats, stability protocols, Specifications, Method of analysis, Analytical reports etc. for the analytical support to the Laboratories To monitor and co-ordination of Stability Management activities like set-up and withdrawal of Bio/pilot/Exhibit batches, commercial batches and other stability samples as per ICH guidelines. Responsible for LIMS related activity of stability Management (Stability Protocol Review & Approval in LIMS and samples pulling based on pulling time etc.,), Review of LIMS Data. To co-ordinate within the groups and partner companies for the initiating of stability study related to new as well as existing products. Review and co-ordination for stability related equipment qualification activity. Assessment of all supplier driven change controls, SOP related change controls with respect to impact on stability. Assessment and completion of action items for change in stability specification. Change control assessment of all manufacturing and packaging documents creation and revision. Responsible to work in coordination with Lead investigators for all stability related deviations other than laboratory deviations. Preparing and assessment of rate of change required for stability failure investigations required for GTA and ARPL. Responsible for any CAPA implementation and monitoring from stability team. Review of Monthly alarm report for all stability chambers. Review of Quarterly alarm trending report for all stability chambers. Generation & Review of Monthly stability compliance Report of laboratories. Generation & Review of Stability Summary Report for Stability Batches Review of all stability commitments for each products made by Regulatory affairs department for submission purpose. Providing data to Regulatory dept. for Annual Reports as per request. Results recording with respective stability batches in SAP Assessment of SAP Notification task for all retest batches. SAP notification assessment for re-pack/de-pack batches. Assessment and creation of Commitment for commercial stability batches as and when new product is launched and on quarterly basis. Review of the engineering M1 & M2 Notification with respective to the Stability chamber activities. Documentation control: ensuring archival / retrieval and updation of documentation as per regulatory compliance To be responsible for all activities, including cGMP/cGLP/cGXP, documentation and implementation of departmental Quality Systems. To provide, execute and impart training to colleagues with respect to procedures review and updating encourage high performance culture and a safe working environment for all employees. Job Requirements Education Minimum M.Sc / B.Pharm or any equivalent degree Knowledge, Skills and Abilities Knowledge in LIMS with respective to the Stability Managment Knowledge in the Quality Systems Handling of Stability Management activities Experience in working online modules / software Experience Minimum 7 to 14 years of experience in GMP regulated Pharmaceutical Industry At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for effective review and approval of Laboratory investigation reports / Deviations / Corrective and preventive actions (CAPA s)/ change controls/ method transfer/ validation protocols and reports in a timely and compliant manner. Job Responsibilities Review and approval of lab investigation reports , Deviations, Corrective action and preventive actions (CAPA s) and Temporary change controls. Provide guidance on technical assessment/ investigations to team members and stake holders to ensure compliance. Review of standard operating procedures. Assessment and approval of change controls. Review and approval of instrument qualification and calibtration documents in timely manner. Review and approval of method transfer and validation protocols/ reports. Review and approval of specifications and MOA. Provide support to self inspections and audits by regulatory authorities / third parties as required. Responsible and accountable for managing subordinates and to provide all required training requirements, tools and follow procedures in accordance with applicable regulatory and other pertinent requirements. Provide training as required. Recruit, train, develop and manage effectively the ongoing performance of the direct reports, which includes but not limited to: Reviewing and updating team developing plans, ensuring that all the team members are properly trained and qualified to execute their duties. Providing coaching, feedback and recognition. Perform all work in support of our corporate values of collaboration,courage, perseverance and passion. Demonstrates strong and visible support of values. Communicate corporate vision and goals to direct reports in an effective and efficient manner. All other duties as assigned. Job Requirements Education Minimum Bachelor of Pharmacy / Science or any equivalent degree. Knowledge, Skills and Abilities Possess sound knowledge in quality management system which comprises of change controls, deviations and LIR s Hands on experience in Trackwise application, LIMS and Empower application. Maintains good interpersonal skills and communication skills. Knowledge on method transfer and validation activities. Experience Minimum 8-12 years of experience in GMP regulated pharmaceutical industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

;:" Your Responsibilities Ensure and adherence and compliance to ADM safety and Policies. Responsible for total oil packaging operations. Responsible for implementation of GMP and Food Safety Policies Planning Dispatches with sales team and Logistics Providers Follow- up of oil production with reference to the production plan as approved by the plant head Understanding Technical Specifications of different types of packaging materials and govt. norms. Ensure product quality as per customerquality standard. Ensure availability of packaging materials Ensure checking of samples in accordance to requirements of the ADM specialization and quality. Responsible for final inspection of finished products. Optimum utilization of Manpower to achieve the production target manpower development. Evaluate workers performance and ensure discipline Identify training need and provide training, as required time to time. Ensure cost reduction by reducing all kind of wastage and efficiently utilize all kind of resources. Handle Audits and Inspections. Ensure calibration of all the electrical packaging equipment. Ensure proper maintenance of records of all issuance of all issuing, receiving, materials, production, delivery, wastage, test results etc. Any other task as assigned by the Management. Your Profile Bachelor Degree in Food Technology, Packaging Specialization or other stream. Must have 5-8 years strong related experience in team leading role. Should have experience of working in a FMCG or manufacturing organisation Legal metrology laws regulations. Language Proficiency-English, Hindi. Marathi-good to have