Responsible for Planning, execution and clouser of site self inspection/internal audits. Responsible for monitoring of all CGXP activities at site. To ensure the effective implementation of the global action at site as per the defined timeline to maintain the continual improvement in the quality system. Responsible for coordination and management of regulatory inspections, including regulatory other audits to ensure Anytime Audit Readiness. Responsible for maintaining, reviewing of contract service provider documents quality agreements of all contract service provider. Ensure the GMP nad GDP complinace. Responsible to ensure GXP computerized systems at site are in compliance with the current regulatory standarads. Ensure implementation of relevant quality policies , standarads and procedures for computerized systems. Ensure key documents of computerized systems consistently meets the required quality standarads throughout the lifecycle. Review and approve valdation deliverables and lifecycle documentation for computerized systems. Ensure the availability ofthe site CSVMP as per the quality procedure. To perform the gap assessment for the observations received across the sun sites, ensure the remediation compliance as well with coordination from stakeholders. Ensure timely conducting of QRB monthly review meetings.

Role & responsibilities Operation of all production equipments, execution and monitoring the process as per BMR during shift hours. To perform all the calibration activities for W.B and holding tanks receivers as per SOP and maintain calibration records as updated. To monitor overall plant parameters & utilities. To control the spills, salvaging of spills in the plant. To ensure personal hygiene inside the plant. To ensure all the chemicals are handled as per MSDS. Ensure to maintain online documentation in plants with respect to BMR, cleaning records, all production related log books.

We are looking for a dynamic and experienced General Manager to spearhead Sales and Marketing efforts within our CDMO markets at Chieron Active Ingredients. This pivotal role demands a seasoned leader capable of building and nurturing a robust CDMO business, leveraging extensive industry knowledge and contacts. The ideal candidate will possess a comprehensive understanding of the entire product development lifecycle, coupled with strong technical acumen and familiarity with global pharmaceutical regulations. This individual will collaborate closely with technical leaders, both internally and externally, to drive business growth. The role requires a strategic mindset, patience, and unwavering persistence, given the long sales cycles inherent in the CDMO sector. The General Manager will be responsible for developing and executing sales strategies, managing key accounts, ensuring regulatory compliance, and fostering innovation within the CDMO division. They will also play a crucial role in identifying and capitalizing on emerging pharmaceutical industry trends to maintain Chieron Active Ingredients' competitive edge. This is a high-impact position for a results-oriented professional eager to shape the future of our CDMO business. Job Details: Industry: Active Pharmaceutical Industry Department: Sales and Marketing (CDMO) Role: General Manager (Sales and Marketing for CDMO Markets) Location: Hyderabad Experience: 18 to 25 years Employment Type: Full-time Qualifications: Bachelor's or Master's degree in Chemistry, Pharmacy, or a related field. MBA preferred. Responsibilities: Strategic Leadership & Business Development Lead the development and execution of the CDMO sales and marketing strategy to achieve revenue targets and market share growth. Identify and evaluate new business opportunities within the CDMO landscape, including market trends, competitive analysis, and potential partnerships. Develop and maintain strong relationships with key decision-makers at target pharmaceutical companies. Oversee the preparation and presentation of compelling proposals and presentations to prospective clients. Monitor and report on market trends, competitor activities, and customer feedback to refine sales and marketing strategies. Represent Chieron Active Ingredients at industry conferences, trade shows, and networking events to enhance brand visibility and generate leads. Sales Management & Key Account Management Manage and mentor the CDMO sales team, providing guidance, training, and support to achieve individual and team goals. Develop and implement effective sales processes and tools to optimize sales efficiency and conversion rates. Oversee the management of key accounts, ensuring customer satisfaction and fostering long-term partnerships. Negotiate contracts and agreements with clients, ensuring favorable terms and conditions for Chieron Active Ingredients. Monitor sales performance metrics and identify areas for improvement, implementing corrective actions as needed. Collaborate with cross-functional teams to ensure seamless execution of CDMO projects and deliverables. Technical & Regulatory Compliance Maintain a thorough understanding of API manufacturing processes, pharmaceutical regulations (GMP, GLP), and quality standards. Ensure that all CDMO activities comply with relevant regulatory requirements and industry best practices. Collaborate with the technical and quality assurance teams to address client inquiries and resolve technical issues. Oversee the preparation and review of technical documentation, including CMC sections, regulatory submissions, and quality control reports. Stay abreast of changes in global pharmaceutical regulations and update internal processes accordingly. Participate in client audits and inspections, ensuring successful outcomes and maintaining a strong reputation for quality and compliance. Project Management & Cross-Functional Collaboration Oversee the project management of CDMO projects, ensuring timely completion, adherence to budget, and achievement of quality objectives. Collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure seamless project execution. Communicate effectively with clients and internal stakeholders, providing regular updates on project progress and addressing any concerns. Identify and mitigate risks associated with CDMO projects, implementing contingency plans as needed. Track project performance metrics and identify areas for improvement in project management processes. Ensure that all project documentation is complete, accurate, and readily accessible. General Expectations and Past Experiences: Proven track record of successfully building and managing CDMO sales teams and achieving revenue targets in the pharmaceutical industry. Extensive knowledge of API manufacturing processes, pharmaceutical regulations (GMP, GLP), and quality standards. Demonstrated expertise in contract negotiation, strategic account management, and business development within the CDMO sector. Strong technical acumen and ability to communicate effectively with technical leaders, both internally and externally. Excellent communication, presentation, and interpersonal skills, with the ability to build rapport and influence key decision-makers. Experience in developing and implementing sales and marketing strategies to drive business growth in the CDMO market. Proficiency in project management methodologies and tools, with the ability to manage multiple projects simultaneously.

We are looking for a dynamic Assistant Manager - Sales and Marketing to spearhead our domestic API sales and expand our market presence at Chieron Active Ingredients Pvt. Ltd. In this pivotal role, you will drive revenue growth by developing and executing strategic sales plans targeting Indian formulation companies adhering to regulatory standards. You will manage key client relationships, ensuring their needs are met with comprehensive support, from accurate documentation and COAs to regulatory assistance. Your expertise in the Indian API market, coupled with a strong understanding of GMP and CDSCO guidelines, will be critical in conducting market analysis, forecasting sales, and negotiating contracts. Collaborating closely with internal teams, you'll ensure regulatory compliance and maintain the highest quality standards. This position demands a proactive individual capable of navigating the complexities of pharmaceutical sales, building lasting relationships, and contributing significantly to Chieron's continued success in the competitive API landscape. Your ability to analyze market trends, present compelling product portfolios, and drive ethical sales practices will be key to achieving and exceeding sales targets. Job Details: Industry: API Department: Sales and Marketing Role: Assistant Manager - Sales and Marketing Location: Bangalore Experience: 7-12 years Employment Type: Full-time Qualifications: Bachelor's degree in Pharmacy, Chemistry, or related field. Responsibilities: Sales Strategy and Business Development Develop and implement strategic sales plans to achieve revenue targets within the Indian domestic API market, focusing on formulation companies compliant with regulatory protocols. Identify and pursue new business opportunities by targeting Indian pharmaceutical companies requiring regulatory-compliant APIs, expanding Chieron's customer base. Conduct comprehensive competitor and market analysis to identify trends, assess price sensitivities, and inform strategic decision-making. Present Chieron's product portfolio to potential clients, emphasizing regulatory strengths, quality standards, and unique value propositions. Negotiate pricing and contract terms with clients, aligning with internal margin expectations and ensuring mutually beneficial agreements. Develop and execute strategic sales plans to expand Chierons presence in the Indian domestic API market, particularly with formulation companies following regulatory protocols. Key Account Management and Customer Relationship Management Manage and nurture relationships with key clients in the Indian domestic API market, ensuring high levels of customer satisfaction and retention. Address customer inquiries and provide comprehensive support, including accurate documentation, COAs, regulatory information (e.g., DMFs), and post-sales service. Develop and maintain account plans for key clients, conducting regular performance reviews and identifying opportunities for growth. Utilize CRM systems to maintain accurate client records, track sales progress, and monitor key performance indicators. Coordinate with cross-functional teams to address customer needs and resolve issues effectively. Act as the primary point of contact for key clients, building strong relationships and fostering long-term partnerships. Sales Forecasting and Market Analysis Develop accurate sales forecasts for the domestic API market, considering historical data, market trends, and competitive landscape. Analyze sales performance data, identifying key trends, opportunities, and areas for improvement. Monitor and report on market trends, including price competition, formulation launches, and regulatory changes. Provide regular updates and insights to management on market conditions and sales performance. Prepare monthly and quarterly performance reports, highlighting key achievements and challenges. Conduct market research to identify new opportunities and potential threats. Regulatory Compliance and Quality Assurance Ensure all sales activities comply with Indian pharmaceutical regulatory frameworks, including GMP, CDSCO, and other relevant guidelines. Collaborate with internal RA, QA/QC, and production teams to support domestic audits and compliance requirements. Promote ethical sales practices and maintain transparency in all dealings with clients and stakeholders. Stay up-to-date on changes to Indian pharmaceutical regulations and ensure compliance with all applicable laws and regulations. Maintain accurate records of all sales activities and ensure compliance with company policies and procedures. Communicate regulatory requirements to clients and provide guidance on compliance matters. General Expectations and Past Experiences: Proven track record of success in domestic API sales within the Indian pharmaceutical market, with a strong understanding of regulatory requirements (CDSCO, DMF filing). Demonstrated ability to develop and execute strategic sales plans, manage key accounts, and negotiate contracts effectively. Strong knowledge of API manufacturing processes, quality standards (GMP), and regulatory compliance requirements. Excellent communication, presentation, and interpersonal skills, with the ability to build strong relationships with clients and internal stakeholders. Proficiency in using CRM systems to manage client data, track sales progress, and generate reports. Ability to analyze market trends, identify opportunities, and develop effective sales strategies. Bachelors degree in Pharmacy, Chemistry, or a related field is required.

Monitor and manage inventory levels of raw materials, intermediates, and finished goods. Coordinate with the procurement team to place orders for raw materials and essential supplies. ensure that all materials are stored as per Good Storage Practices (GSP) and regulatory guidelines (cGMP, FDA). Supervise and guide store personnel in daily operations. Work closely with production and quality teams to ensure material availability and quality compliance. Coordinate for sampling and quality testing of incoming materials. Oversee the storage conditions, including temperature and humidity controls, as required by API standards. Manage warehouse space to optimize storage capacity and accessibility. Ensure cleanliness, safety, and organized storage practices within the warehouse. Ensure that all safety protocols are followed by the stores team. Maintain and update safety records for storage and handling of chemicals and hazardous materials. Coordinate with the Health and Safety team to conduct periodic safety training. Generate reports on inventory status, usage trends, and stock movements for management. proficiency in ERP software for inventory management (SAP, Oracle, etc.). Strong understanding of regulatory compliance in API manufacturing (GMP, ICH). Responsible for PM dispensing activity, handling of all related log books. This role will involve supervising store operations, ensuring timely availability of materials, maintaining accurate records, and coordinating with internal departments for smooth workflow.

Develop and implement QA strategies and systems. Lead and mentor the QA team. Ensure compliance with regulations and standards like ISO. Drive process improvements, manage audits, collaborate with teams, maintain documentation.

Key Responsibilities : Controlling the process & validating the quality Rotational shift work is required. Calculating & Maintaining the OEE Conduct time and motion studies, root cause analyses, and failure mode analyses. Collaborate with cross-functional teams, including Quality, Maintenance, and Production. Control Material consumption, Wastage & labour cost per unit Actively Participating in Maintenance Desired profile of the candidate 3 years of relevant experience in process control & optimization, production support & validation of Quality & Maintenance Technical Competencies: Knowledge of paint & chemicals on plastic products Experience of using a Chain Conveyor for continuous production Clean Room Protocols Process & Quality control Working knowledge of quality systems (e.g., FMEA, HAZOP, GMP, ISO 9001) Personal Attributes: Detail-oriented and quality-focused Willingness to work in plant or field environments Adaptable and open to learning new systems and technologies High level of integrity and professionalism

We are looking for a dynamic Business Development Executive to drive growth and expand our market presence in the Indian pharmaceutical sector at Chieron Active Ingredients. As a pivotal member of our sales team, you will be instrumental in identifying, qualifying, and developing leads to fuel our API sales and CDMO/CMO services. Your responsibilities will span across conducting thorough pharmaceutical market research, executing sales strategies, scheduling client meetings, and managing the seamless exchange of samples. Reporting directly to the Sales and Marketing Manager, you will leverage your expertise in the Indian pharmaceutical market to perform competitive analysis, generate insightful sales analytics, and contribute to effective pricing strategies. This role demands a proactive individual with exceptional presentation skills, adept at cold calling, networking, and fostering strong customer relations. Your ability to navigate the API product development lifecycle, enhance brand awareness, and manage sales operations will be crucial in achieving our business development goals. Join us and play a key role in delivering quality and cost leadership to our global customers. Job Details: Industry: Active Pharmaceutical Industry Department: Sales and Marketing Role: Business Development Executive Location: Bangalore Experience Required: 4 years Employment Type: Full-time Key Area: General Areas of Support Required Qualification: Bachelor's degree in Pharmacy, Business Administration, or a related field Responsibilities: Lead Generation and Qualification Identify and develop new leads through market research, networking, and cold calling within the Indian pharmaceutical market. Qualify leads based on established criteria, assessing their potential for API sales and CDMO/CMO services. Maintain a detailed database of leads, tracking their progress through the sales pipeline. Collaborate with the marketing team to generate targeted lead generation campaigns. Analyze market trends and competitor activities to identify new lead opportunities. Prepare and present regular reports on lead generation activities and outcomes to the Sales and Marketing Manager. Sales and Business Development Execute sales strategies to achieve business development goals in the API and CDMO/CMO sectors. Schedule and conduct meetings with potential clients to present Chieron Active Ingredients' capabilities and offerings. Manage the exchange of samples with clients, ensuring compliance with GMP and quality standards. Develop and maintain strong relationships with key decision-makers at pharmaceutical companies. Negotiate contracts and agreements with clients, ensuring favorable terms for Chieron Active Ingredients. Monitor sales performance, identify areas for improvement, and implement corrective actions. Market Research and Analysis Conduct comprehensive pharmaceutical market research to identify trends, opportunities, and competitive threats. Analyze competitor activities, pricing strategies, and market share to inform sales and business development strategies. Prepare and present market analysis reports to the Sales and Marketing Manager and other stakeholders. Stay up-to-date on regulatory changes, industry trends, and technological advancements in the pharmaceutical sector. Use market insights to provide recommendations for new product development and market entry strategies. Evaluate the effectiveness of marketing campaigns and sales initiatives through data analysis and reporting. Sales Operations and Reporting Provide regular reports on sales activities, lead generation, and market analysis to the Sales and Marketing Manager. Utilize sales analytics tools to track key performance indicators (KPIs) and identify areas for improvement. Manage sales operations, including contract management, sample tracking, and customer relationship management (CRM). Ensure compliance with all relevant regulations, policies, and procedures. Collaborate with cross-functional teams to streamline sales processes and improve efficiency. Contribute to the development and implementation of pricing strategies to maximize profitability. General Expectations and Past Experiences: Possess a Bachelor's degree in Pharmacy, Business Administration, or a related field, with at least 4 years of experience in API sales or business development within the pharmaceutical industry. Demonstrated expertise in the Indian pharmaceutical market, including knowledge of regulatory requirements, competitive landscape, and key players. Proven ability to generate and qualify leads through market research, networking, and cold calling. Strong presentation skills, with the ability to effectively communicate complex information to a variety of audiences. Proficiency in sales analytics, CRM software, and other sales operations tools. Exceptional interpersonal and customer relations skills, with a focus on building long-term partnerships. Goal-oriented and self-motivated, with a track record of exceeding sales targets and achieving business development objectives.

Operating and maintaining equipment Monitoring production processes Monitor production processes, identifying and reporting any issues Maintain accurate and complete records of production activities Ensuring adherence to quality standards and GMP Required Candidate profile Previous experience in API pharma manufacturing or a similar industry Ability to operate and maintain equipment Knowledge of GMP and other relevant regulations is essential

1) Understand quality concepts and work on continual improvement.2) Support new product development and nutrition studies.4) Have knowledge of FG, raw material, and packaging material testing.5)Maintain good GMP and GHP at the manufacturing location.

Role & responsibilities To perform all test for in process product & finish product as per the specification and schedule. To investigate failure of FP / Out of specifications (OOS) and take the corrective and preventive actions (CAPA). To perform and ensure the calibration of instruments as per the schedule. To perform and ensure preparation of reagent / volumetric solution as per schedule. To perform and ensure observation of FP retained samples. To ensure that all documents related to the testing data and related papers are maintained properly. To implement Corrective and Preventive Action (CAPA). To carry out the sampling of all the materials according to Standard Operating Procedure (SOP). To carry out the testing of Raw Material and Packing Material according to approved procedure. To release Raw Material and Packing Material. To carry out the calibration of instruments as per the schedule. To prepare the working standards as per the guidelines and various pharmacopoeias. To ensure the status tag on the released material and transfer such material in the released area. To follow the Good Laboratory practices and Good Manufacturing practices (GMP). To prepare requirement list of chemical & reagent for procurement. To perform the analysis of stability sample as per current specification. To compile the data required for internal quality audit in the plant, as and when required. Preferred candidate profile Managerial skill Problem solving & Decision Making skill Guiding skill Team development skill System thinking Delegation Interested candidates can share their CV at [HIDDEN TEXT] Fresher can also can apply and their CV on the mentioned email ID

Role & responsibilities To ensure the clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines. To do sampling of Water for Injection (WFI), Double Reverse Osmosis (DRO), Single Reverse Osmosis (SRO), Raw water and pure steam. To analyze water samples for pH, conductivity, Bacterial Endotoxin Test (BET), bioburden, Total Organic Carbon (TOC), pathogens, chlorides, hardness, silt density index and other testing as per the requirements. To analyze the samples of water system after maintenance work. To observe and record the results the microbiological plates and test tubes after analysis as well as supervise discarding method of same. To perform the timely microbiological testing of finished product samples, pre-sterile samples, Raw material as well as Packing material sample as per the requirements and SOPs and record the results for the same. Preferred candidate profile Ready to work in Rotational shifts. Excellent understanding about working area. Initiator and Learner. Decision making ability. Team player and if required, can provide training to other team members. Good communication. Candidate should have good exposure in sterility, BET, & MLT. Candidates with exposure in Parenteral/Injectable will only be considered. Male Candidates would be preferred. The above positions are for Pharma experienced candidates and for rotational shifts only. Fresher candidates can share their resume on [HIDDEN TEXT]

Ensuring the quality of APIs through testing, analysis, & documentation Sample & inspect raw materials Maintain an accurate & complete record of testing, analysis Investigate deviations from the quality standard Ensure compliance with GMP regulations Required Candidate profile Bachelor's degree in B.Sc/M.Sc Chemistry, B.Pharm/M.Pharm. Previous experience in QC in API pharma manufacturing Strong knowledge of analytical techniques & instrumentation, e.g., HPLC, GC, UV-Vis

Role & responsibilities To ensure timely documentation of housekeeping and to check the cleaning record on a daily basis. To ensure implementation of Standard Operating Procedures (SOPs) for administration and report to Department Head Manufacturing and QA if the deviation is observed. To check in-process control parameters of housekeeping through design document on a daily basis. To implement the GMP norms on a continuous basis. To ensure issuance of material as per the norms and SOP. To ensure good housekeeping of the entire plant, technical floor, ancillary services like canteen, utility building & campus. To ensure the proper upkeeping of housekeeping equipment, laundry equipment & office equipment inside the plant. To ensure pest control activities as per requirement. To ensure waste material handling area and disposal area are clean. To maintain the laundry facility inside the plant for washing of Clean Room Garments. To ensure the availability of general uniforms for staff & workers, factory shoes & locker facilities. To facilitate first aid services for any accident or general illness. For any major injury or accident, facilitate transportation to nearest medical facilities for medical treatments. To issue housekeeping materials for other departments. To maintain online documentation. To prepare daily and monthly report. To coordinate with campus administration for selling scrap and burning preprinted material. To ensure shoe cleaning of all staff and worker. To prepare requisition for housekeeping materials purchase. To suggest the change in SOPs if required. To ensure the availability of the workers for daily housekeeping activities. To ensure timely and quality cleaning for customer satisfaction. To monitor and control all SOPs and Current Good Manufacturing Practice (cGMP) Guidelines. Preferred candidate profile Lateral coordination Team working Policy compliance Task completion orientation Candidate from pharma company would be preferred. Interested candidate can share their CV at [HIDDEN TEXT]

Job Title: Warehouse Manager Rice Manufacturing Plant Location: Karnal, Haryana Industry: Food Processing / Rice Milling Experience: 8+ Years (Preferably in FMCG or Agri/Food Industry) We are seeking an experienced and proactive Warehouse Manager to oversee and manage the entire warehousing function of our rice manufacturing plant in Karnal. The ideal candidate should have strong expertise in warehouse operations, inventory management, team supervision, and coordination with cross-functional departments. Key Responsibilities: Manage end-to-end warehouse operations including receipt, storage, dispatch, and documentation of raw materials (RM), packaging materials (PM), and finished goods (FG). Monitor and maintain accurate inventory levels through regular stock audits and cycle counts. Ensure proper FIFO/FEFO practices and implement best warehousing practices to reduce wastage and maintain quality. Coordinate with production, procurement, and logistics teams for timely inward and outward movement of goods. Optimize warehouse layout and space utilization for improved efficiency. Supervise loading/unloading activities and ensure timely dispatches as per customer or market requirements. Implement and maintain SOPs for warehouse operations in compliance with food safety and hygiene standards – FSSAI, BRCGS, HACCP, GMP, etc. Manage contract/shift labor and ensure workforce productivity and discipline. Handle warehouse documentation, GRNs, gate entries, bin cards, and ERP/SAP entries accurately. Ensure adherence to safety protocols and maintain a clean and organized warehouse environment. Preferred Candidate: Bachelor's degree with relevant experience in warehouse/logistics management. Proficient in Excel, SAP/ERP, and warehouse management systems. Strong leadership, organizational, and communication skills.

Summary The Technical Project Leader will, jointly with the CMC team, lead and manage all technical development activities for assigned small molecule projects within Technical Research Development (TRD); represent TRD as core member in global project teams to define the global CMC strategy for the development, submission, approval and life cycle management of a product(s); maximize the support to local programs and partners; lead CMC teams with strong strategic focus, quality environmental awareness, management capabilities, scientific and technical expertise; act as the TRD representative in complex projects involving external partners and/or highly innovative projects/processes. About the Role Major accountabilities: Performs strategic planning of more complex and/or accelerated projects with e.g., multiple candidates / scenarios, or of several projects with varying timescales. Has sense of urgency, aligns, and coordinates multiple activities in complex plans. Establishes realistic project timelines to achieve milestones and goals, organizes additional resources if needed to fulfill planning, tracks progress and takes actions if obstacles emerge or priorities change. Establishes technical development plans in line with priority classification of project, gated by clinical readouts as appropriate and with an enterprise view in consideration of overall portfolio priorities. Establishes high level summaries for presentation to management and stakeholders. Has advanced skill to identify, assess, manage, and communicate CMC risks / program risks. Due to seniority and experience, can handle more difficult risks, issues in more complex projects and handle multiple risks of DS/DP/Device even with junior CMC team members. Provides drug development expertise in addition to technical expertise. Follows standard process but at the same time thinks outside the box based on existing knowledge. Challenges the status quo, is curious and fosters creativity of team members and own creativity. Leverages existing knowledge and implements in EPT/GPT strategy. Continues to follow and stands behind EPT/GPT decisions. For complex late phase programs, Senior TPL supports defined work packages. Build relationships by identifying common interests and priorities with a variety of people inside and outside the organization. Has deeper understanding of current organizational structure, establishes networks and uses own network to resolve challenging situations and manage/drive change. Participates in boards and joins and/or can lead discussions in leadership teams. Is highly skilled in collaborative settings (i.e., external vs internal, CROs, DDs, in-/out-licensing settings). Approaches/analyzes issues and collaborates with other line functions for optimal solutions. Takes into account multiple stakeholder perspectives and approaches to find optimal solutions and build commitment and consensus. Provides knowledge of industry, main competitors, customers and external environment - this includes healthcare industry and global industry, digital and technological advancements. Shares knowledge with CMC community, e.g., by lessons learned sessions. Uses knowledge and experience to challenge and influence CMC line functions and/or EPTs/GPTs in background of the overall drug development strategy / industry insight. Actively contributes to EPTs/GPTs beyond CMC line functions. Is able to navigate and manage the complexity of the dis-ease area GPTs. Leads DDs for assets in development. Is able to cope with time pressure and senior management exposure. Relates to people in an open, friendly, and accepting manner. Understands the formal and informal channels for exchange of ideas and provides constructive feedback. Reacts tactfully when receiving advice, instruction or critical feedback and openly gives and receives feedback. Remains calm and objective and demonstrates respect, composure, and professionalism during difficult circumstances, including difficult interpersonal situations. Learns to manage teams/stakeholders appropriately (utilizing their support). Brings forward sound proposals and shares lessons learned, without passing the blame. Anticipates setbacks and stays in control - takes criticism as intended for situations (not personally or toward particular individuals). Recovers quickly from problems and setbacks. Exhibits servant leadership and provides mentoring/coaching to junior TPLs, line functions and CMC team members to support their professional and personal growth. Leads by example and drives decisions. Minimum requirements Successfully demonstrated several years (minimum of 2-3 years) of directly related experience as functional project leader and relevant experience as Associate TPL or equivalent. Has strong scientific/technical knowledge, understands technical development tasks. Is able to establish/maintain DS/DP/Device supply plan (in alignment with CSPL). Has fundamental knowledge of GMP and regulatory requirements. Has fundamental cross-functional knowledge (PK/PD, tox, clinical, commercial) regarding drug development. Manages end to end technical drug development and knowledge. Completed basic project management training. Potential extension (not mandatory): Basic/Bronze IQP training. Is adept at using and regularly uses/updates project management tools available in TRD (e.g. Gantt charts, MS Project, Resource Cockpit). Knows fundamental IT tools. Has effective presentation skills.

Role & responsibilities production chemist Preferred candidate profile pharma experience, API, BULK DRUG,GMP, GLR,SSR,CENTRIFUSE,BPR,

* Utility ops: Cooling tower, Brine, Chiller, Air Compressor, N Plant * Water treatment monitoring * Log sheet & GMP compliance * Equipment handling & safety follow-up * Coordination with supervisors

Knowledge of preparation of BMR, BPR, MFR, SMP, Change control, Deviation. Develop and implement quality assurance system Oversee quality control process Conduct internal audits & inspections Ensure laboratory compliance with regulatory requirements Required Candidate profile Bachelor's degree in a relevant scientific field like B.Pharma, M.Pharma, B.Sc Previous experience in quality assurance in laboratory setting or an API Mfg company Min 5 years of experience required

-Responsible as a specialist for warehouse logistics whilst meeting Pharmaceutical Regulatory and Corporate Guidelines. About the Role: Responsible for the site Master Data processes aimed to ensure accurate and timely creation and maintenance of the master data in the ERP System, in accordance with local and global requirements. -The Material Planner drives the tactical purchasing process for all materials to ensure materials availability and execution plan feasibility in accordance with Site inventory policy. Key Responsibilities: Master Data -Set up and perform complex local And global master data set up And establish process, guidelines, business matrix and SLA time lines in in GxP environment in adherence to Novartis compliance. Be SME in the assigned area of work -Support data collection and reporting of important metrics -Logistic, WAndD -Responsible that all logistic processes are proceed in a timely, high quality, efficient and effective manner and in full compliance with all laws and supply chain management policies and procedures. Identify and drive continuous improvement projects. Ensure material availability in line with the approved production plan. Ensure daily MRP oversight for all BOM material, analysis of requirements and Purchase Orders management. Ensure daily MRP oversight for all BOM material, analysis of requirements and Purchase Orders management. Own, in ERP System, MRP relevant data and materials technical specifications and ensure no Purchase Orders are past due in the ERP System. Management of purchased item Complaints/Returns to supplier. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) -Provide expertise and system support for returns, rebates and credit/debit notes -Define and decide on priorities for physical deliveries in collaboration with other functions (eg LEX) for 3rd party customers and cross divisional supplies -Act as SPOC for partner concern issues for assigned customers -Influencing and connecting relevant partners to speed up (system) issue resolution -Material Planner -Ensure management of daily MRP exception messages And appropriate follow up. Provide a load balanced dispatch list for incoming materials to the warehouse and Quality department that ensures these activities are completed in line with the production needs. Essential Requirements: Collaborating across boundaries. Operations Management and Execution. Project Management. Inventory Management, Gap Analysis, Cost Efficiency and efficiency of supply processes -Standard Master Data KPIs eg Completeness, Consistency and Accuracy. Desirable Requirements: Bachelor / Masters Degree with experience in Pharmaceutical Industry/ specifically GMP background.

The Technical Writer - Change Control Management is responsible for developing, managing, and maintaining documentation related to change control processes within a regulated manufacturing environment. This role ensures documentation accuracy, consistency, and compliance with regulatory and organizational standards. The Technical Writer will leverage their knowledge of science and manufacturing technologies to collaborate effectively with cross-functional teams, streamline documentation workflows, and support the organization s change control management processes. Key Responsibilities Develop, revise, and maintain high-quality documentation related to change control processes, ensuring alignment with cGMP and other regulatory standards. Collaborate with cross-functional teams, including Quality, Operations, and Engineering, to ensure all change control documentation is accurate, comprehensive, and aligned with organizational objectives. Utilize scientific and technical knowledge to accurately interpret and document manufacturing processes, equipment, and technology changes. Manage the lifecycle of change control documentation, including updates, version control, and accessibility for stakeholders. Facilitate change control review meetings, capturing key information and translating it into actionable and clear documentation. Standardize templates and formats for change control documentation to enhance consistency and usability across the organization. Provide support during audits and inspections by ensuring accurate and readily available change control documentation. Track and report on metrics related to change control documentation, including timeliness, compliance, and quality. Train and mentor team members on documentation best practices and change control management processes. Contribute to process improvement initiatives by identifying and addressing gaps in change control documentation workflows. Ensure that data integrity checks are conducted to verify that all the data is complete, consistent, and free from errors before proceeding with any further analysis or reporting. Key Performance Indicators 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: Good Documentation Practice Effective communicator Strong cross functional collaboration Adaptability to Embrace Change Effective stakeholder engagement Manufacturing Process Knowledge Of GMP (Good Manufacturing Practices) Change Control Deviation management Corrective and preventive action (CAPA) Continual Improvement Process General HSE Knowledge Manufacturing (Production) Background Education : bachelors degree in a science or engineering-related field (eg, Biology, Chemistry, Mechanical Engineering, or similar disciplines). Languages : English fluent Experience : 5+ years of experience in technical writing, preferably within a regulated manufacturing or scientific environment. 2+ year of experience in in drafting and managing change control documentation within GxP settings. Strong understanding of change control processes, cGMP, and regulatory compliance. Fundamental knowledge of science and/or manufacturing technologies, with the ability to interpret technical and scientific information. Proficient in document management systems and technical writing tools. Excellent attention to detail, organizational skills, and the ability to manage multiple priorities. Experience supporting audits and inspections is a plus. Familiarity with Lean principles or continuous improvement methodologies is advantageous. Proficiency in English (oral and written) is required

-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems. About the Role: This position is responsible for quality oversight of contract manufacturers for drug product/drug substance/intermediate product/raw material of ADACAP. Key Responsibilities: Develops and maintains a Quality Assurance Agreement in cooperation with the external partners. Responsible for the initial qualification and onboarding of contract manufacturers as we'll as for performing regular quality risk assessments. Ensures that all aspects of manufacturing, testing, release and distribution of drug substance/drug product/ intermediate product/material are in compliance with applicable ADACAP and Novartis standards, the effective Quality Assurance Agreement, relevant guidelines and the Quality Management System of the external partners. Manages and oversees contract manufacturer s activities related to quality processes such as deviations, complaints, recalls, counterfeits, product tampering, stability failures, etc according to the Quality Assurance Agreement and the Novartis Quality Manual. Ensures investigations are appropriately executed within agreed timelines, including documentation and effective measures to prevent recurrence. Support the Novartis audit of contract manufacturers and act as QARP and or FURP as required. Ensures that change requests, either from contract manufacturer or from ADACAP, are managed according to the Quality Agreement and ADACAP change control procedures from receipt, through to the implementation and closure. Reviews third party documents from a quality point of view (ie product test methods, specifications, and protocols/reports for activities such as stability, analytical method transfer, manufacturing process transfer, product comparability, process characterization, process validation, etc). Performs, coordinates or archives GMP documentation as defined by the Quality Agreement and ADACAP SOPs. Responsible for compiling product quality reviews in cooperation with external partners. Initiates and drives quality improvement projects as required. Supports the quality function on general topics as assigned. Writes and maintains general concept descriptions of the assigned topics and presents the assigned topic in audit situations. Develops related procedures or provides input as needed. Escalates significant quality incidents and supply risks as per ADACAP and Novartis escalation policies to management. Responsible for reporting and trending of defined key performance indicators per assigned contract manufacturers. Implement and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External suppliers. Commitment to Diversity Inclusion: : We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Commitment to Diversity Inclusion: : Essential Requirements: At least 6 years of experience in pharmaceutical quality assurance, quality control or manufacturing At least 3 years of experience in a Quality Assurance function Thorough knowledge of cGMP requirements and their practical application in routine biological manufacturing Proven track record of maintaining quality oversight on external partners Experience with biological manufacturing would be an additional asset Good communication skills Team and consensus builder, with definitive and authoritative decision making ability. Desirable Requirements: Higher university degree (Masters, PhD or equivalent) in Pharmaceutical, Chemistry, Biochemistry, or another related science Languages: Fluent in speaking and writing in English

The Analytical Science and Technology (AST) Expert is responsible for coordination and management of analytical activities of commercialized products as we'll as to provide scientific analytical support. About the Role: The Analytical Science and Technology (AST) Expert is responsible for coordination and management of analytical activities of commercialized products as we'll as to provide scientific analytical support. Key Responsibilities: Coordination and management of analytical method transfers and stability studies. Compilation of data reports. Compilation of Quality control monographs describing test procedure and specification setup. Scientific analytical support for quality control, production, registration, marketing. Presentation and discussion of analytical data in local and international project teams. Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as we'll as changes and complaints. Cross-functional interface with Manufacturing Science Technology team, analytical development, production and regulatory department. Management and coordination of analytical activities at external laboratories (CROs). Support for trouble shooting activities and continuous improvement initiatives. Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)). Budgeting and cost control of external analytical activities. Contribution to QC/AST network teams. Management of reference substances and control samples. Essential Requirements: Minimum 10 years in pharmaceutical industry and/or analytical laboratory in GMP environment. MS Office- and other standard IT applications. External orientation: proactive communication, collaboration and exchange with PUs and SUs within local organisation and Novartis organisation. Innovation: continuously thrives for improvements and questions processes and procedures for improvements. Reacts in a flexible and fast way on changes and challenges. Ability to analyse complex processes. Desirable Requirements: Degree in Chemistry, Pharmacy, Biology, Engineering or another related science. Language proficiency: English, German optionally. Why Novartis: you'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:

The Quality Manager responsible for handling technical complaints is tasked with investigating and managing technical complaints raised by clinical investigator sites regarding Investigational Medicinal Products (IMPs) and Medical Devices. Support data integrity incidents, manage escalations, and contribute to global DI (Data Integrity) networks and initiatives. Key Responsibilities: Manages technical complaints investigations to determine root causes and implement corrective actions to prevent recurrence. Collaborate with cross-functional teams to gather data, lead, and perform Root Cause Analysis to identify the likely root cause of events. Review and approve complaints as the site Investigation approver. Manage multiple investigations concurrently. Periodically analyze trends in technical complaints. Participate in audits and inspections, including inspection readiness activities. Handle data integrity escalations. Implement and drive global Data Integrity (DI) network initiatives Essential Requirements: More than Over 14 years of practical experience in the chemical/ pharmaceutical industry or over 5 years of experience in pharmaceutical operations . In-depth knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes-. Proficient in conducting Root Cause Investigations. Effectively collaborate with the Investigation team to ensure timely completion. Experienced in cGMP manufacturing, Quality, and Compliance. Experience in handling the Peptides. Action-oriented with strong skills in building relationships, problem-solving, planning and organizing, conflict management, coaching, and analytical thinking. Capable of completing routine tasks with minimal direction Fast learning abilities, able to manage investigations related to small molecule, biologic and CGT products as we'll as medical devices, packaging and distribution related topics Able to promptly communicate roadblocks and challenges, ensuring timely delivery of investigations. Excellent verbal and written communication skills. Project Management Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including EU-GMP guidelines

Provide quality support in compliance with cGMP requirements and Novartis Quality Management System. Manage Quality aspects projects within area of responsibility. About the Role Major accountabilities: Have expertise in Supplier Quality management and QMS activities. Drafting of QRA, QAA and AMR documents. Handling Supplier Qualifications and change notification. Interpret and compile APQR and/ or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review. Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed. Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports Adherence to the current GxP and compliance policies of Novartis Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, TEDI etc) to ensure appropriate execution of service deliverables Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA etc) and perform follow-up actions if required Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes Requirements for the role Minimum 6 years of experience in Quality assurance activities in pharmaceutical company. GxP knowledge, Basic IT knowledge Good communication, presentation and interpersonal skills Experience of working closely with the global stakeholders Skills: Continuous Learning. Dealing With Ambiguity. Gmp Procedures. Qa (Quality Assurance). Quality Control (Qc) Testing. Quality Standards. Self Awareness. Technological Expertise. Technological Intelligence. Languages : English.