1002 Gmp Jobs - Page 37

Hello Candidate, Greetings from Hungry Bird IT Consulting Services Pvt Ltd. We are hiring Production Manager - API Manufacturing for our client a leading pharmaceutical manufacturing company dedicated to API/Intermediate. Company: Leading Pharmaceutical API Production Company Location: 1) Hyderabad, 2) Visakhapatnam About the Company: Active Pharmaceutical Ingredient manufacturing company, robust product portfolio spread over major product segments encompassing Expectorants, Muscle Relaxants, Analgesic and Anti Fungal. Job Description We are seeking a highly skilled and experienced Production Manager to oversee the production operations of our Active Pharmaceutical Ingredient (API) manufacturing facility. The ideal candidate will have a deep understanding of API manufacturing processes, particularly in the areas of expectorants, muscle relaxants, analgesics, and anti-fungal APIs. Key Responsibilities: Production Planning and Scheduling: Develop and implement comprehensive production plans and schedules to meet customer demands and optimize resource utilization. Monitor production progress and adjust plans as needed to ensure timely delivery. Process Optimization: Continuously evaluate and improve existing production processes to enhance efficiency, reduce costs, and improve product quality. Implement innovative technologies and techniques to optimize production yields and minimize waste. Quality Assurance: Ensure strict adherence to cGMP, ISO, and other relevant regulatory standards. Oversee quality control procedures, including sampling, testing, and documentation. Collaborate with the Quality Assurance team to identify and resolve quality issues promptly. Team Management: Lead and motivate a team of production personnel to achieve production goals. Provide training and development opportunities to enhance employee skills and knowledge. Foster a positive and collaborative work environment. Regulatory Compliance: Stay updated on regulatory requirements and industry best practices. Ensure compliance with all applicable regulations, including FDA, EDQM, and WHO guidelines. Prepare and submit regulatory documentation as required. Safety and Environmental Compliance: Implement and enforce strict safety protocols to minimize workplace accidents and injuries. Promote a culture of safety and environmental responsibility. Ensure compliance with environmental regulations and waste management guidelines. Troubleshooting and Problem-Solving: Identify and troubleshoot production issues, such as equipment malfunctions, process deviations, or quality problems. Implement effective solutions to minimize downtime and maximize productivity. Qualifications and Experience: Bachelor's or Master's degree in Pharmacy, Chemical Engineering, or a related field. Minimum of 10 years of experience in API manufacturing, with a strong focus on expectorants, muscle relaxants, analgesics, and anti-fungal APIs. In-depth knowledge of API manufacturing processes, including synthesis, purification, and formulation. Strong understanding of cGMP, ISO, and other regulatory requirements. Proven track record of leading and managing production teams. Excellent problem-solving, decision-making, and analytical skills. Strong communication and interpersonal skills. Ability to work under pressure and meet tight deadlines. If you are a highly motivated and experienced Production Manager with a passion for API manufacturing, we encourage you to apply. (Interested candidates can share their CV to krishna@hungrybird.in or call on 9966952299.) Please furnish the below-mentioned details that would help us expedite the process. PLEASE MENTION THE RELEVANT POSITION IN THE SUBJECT LINE OF THE EMAIL. Example: KRISHNA, HR MANAGER, 7 YEARS, 20 DAYS NOTICE Name: Position applying for: Total experience: Relevant Experience: Notice period: Current Salary: Expected Salary: Thanks and Regards Krishna +91 9966952299

The role involves managing vendor qualifications remotely and ensuring the timely exchange of relevant documentation to support API production. Additionally, the position includes reviewing QA-related manufacturing and maintenance documentation to ensure compliance with regulatory standards. KEY STAKEHOLDERS: INTERNAL - Site Quality Team (QC, QA), Corporate Functions QUALIFICATION: B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent/Microbiology EXPERIENCE: Need to be ready to live and embrace the Piramal values. Quality professional with 8+ years of QC / QA experience in a regulated pharma companies. Must have hands-on experience in Vendor management Experience in qualifying and re-qualifying vendors, ensuring compliance with regulatory standards. Ability to manage vendor relationships, resolve issues, and track vendor performance metrics. Familiarity with conducting vendor audits and maintaining qualification documentation. Proficient in using vendor management software and coordinating documentation exchanges with vendors. Experience reviewing QA-related manufacturing and maintenance documentation for compliance. Knowledge of regulatory requirements (eg, FDA, GMP) for documentation management. Expertise in assessing and ensuring accuracy of production logs, calibration, and PM reports. Experience collaborating with internal teams to address discrepancies in QA documentation. Knowledge of applicable regulatory requirements / regulations (USFDA, EU, Health Canada, others). we'll-organized and committed, with strong verbal and written communication skills. Good Collaboration skills and Team player. KEY ROLES/RESPONSIBILITIES: Vendor Management: Qualify or re-qualify vendors that supply materials for API production, ensuring compliance with industry standards. Maintain and update the vendor qualification data and related documentation in the system. Communicate with vendors for the submission and receipt of qualification documents. Coordinate with internal departments to ensure that vendor performance meets production requirements. Conduct regular audits of vendors to assess compliance with quality and safety standards. Ensure timely resolution of any issues or discrepancies between vendors and the company. Provide feedback to vendors to improve the quality and efficiency of supplied materials. Track vendor performance metrics and provide reports for review by management. QA Documentation Review: Review QA-related manufacturing documentation, such as batch records, production logs, and related reports. Assess maintenance documentation including preventive maintenance (PM) reports and calibration records. Ensure that all documents are complete, accurate, and comply with regulatory requirements. Collaborate with the QA team to address discrepancies or gaps in documentation. Monitor compliance with internal and external quality standards through document review. Assist in the preparation of quality reports and audits based on document reviews. Support the QA team in identifying areas for improvement in manufacturing processes and documentation. General Responsibilities: Assist in the development and implementation of standard operating procedures (SOPs) for vendor management and documentation review. Participate in meetings and discussions to improve overall supply chain efficiency and vendor relations. Provide support during regulatory inspections or audits, ensuring that all documentation is up to date and available. Coordinate with the production and maintenance teams to ensure timely completion of qualification processes and document reviews. Contribute to continuous improvement initiatives within the vendor management and quality assurance processes.

Oversee and manage day-to-day production activities to meet delivery schedules. Develop and implement production plans to optimize capacity, reduce costs, and enhance productivity. Monitor production KPIs, analyse performance gaps, and drive continuous improvement initiatives Ensure adherence to GMP, regulatory, and safety standards. Collaborate with the Quality Assurance and Regulatory Affairs teams for inspections and audits. Establish robust SOPs and maintain documentation as per compliance requirements. Drive process improvement initiatives to enhance yield, efficiency, and scalability. Evaluate and implement new technologies for cosmetics manufacturing. Provide regular updates and reports to senior management on production performance and challenges. Ensure optimal utilization of raw materials, equipment, and manpower. Plan and prioritize operations to ensure maximum performance and minimum delay.

Role & responsibilities Responsible for Drup Product Manufacturing Ensure compliance to Current Good Manufacturing Practices (cGMP)& documentation thereof for various production activities. Filling line in built CIP, SIP operations Knowledge of Isolator VHP, Blending vessels- CIP, SIP Good at QMS Regulatory inspection exposure WHO-PQ, USFDA, EU GMP, TGA,ROW Experience in O RABS, Isolator filling lines Lyophilizers - ALUS, Manual operations Blending of viral, bacterial vaccines Media fill activities , TRS 1044 updates Responsible for preparing production plan in consultation with PPIC department and execution thereof with effective planning and utilization of Men, Materials and Machineries for quality linked productivity. To approve the instructions relating to production operations and to ensure their strict implementation. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. To ensure that the production records are evaluated and signed by an authorized person. Review investigation of Quality Management System (QMS) including market complaint, Out of Specification (OOS), change controls of manufacturing, risk assessment, Corrective Action and Preventive Action (CAPA) etc. To ensure the qualification and maintenance of department, premises and equipment. Ensure compliance to master formula and process provided in the Batch Manufacturing Record (BMR). To ensure that the appropriate validations are done. Reviewing document like of Standard Operating Procedures (SOPs), Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR)etc. and compliance reports thereof with training of personnel on the same. Ensure appropriate inventory of Consumable in the Department for smooth functioning. Responsible for Co-ordination with Technical Services, Quality Assurance / Quality Control, Finance, Purchase, Warehouse and Administration Departments for effective management of Production targets. Ensure wastage control and optimization of yield at various stages of manufacturing and packaging operations. Ensure compliance to various In-process control guidelines provided in the batch documents. Ensure periodic preventive maintenance of plant and machineries as per schedule worked out by Engineering for optimum performance. Ensure that personnel follow basic safety guidelines during operations. Responsible for the preparation of training calendar for employees and to ensure that the required initial and continuing training of department personnel is carried out and adapted according to need on cGMP and various operational activities. Responsible for preparation of accurate and timely reports of various production activities showing performance and shortcomings against agreed/planned parameters (monthly presentation, work in progress (WIP) statement yield report, monthly planning, expense budget stationary, housekeeping material, production item &capital budget etc). Preferred candidate profile M.Pharm/ B.Pharm / MSc ; Experience- 18 to 25 years Candidate Must have exposure of regulatory Audits should be willing to relocate with family to ahmedabad

DRA Manager Experience- 15+ years Salary Package- 13-17 LPA Must have experience in regulatory Countries dossier preparation and working Should have worked in Injectable Unit location- Baddi Himachal Pradesh

Overview About Omnicom Global Solutions Omnicom Global Solutions is an integral part of Omnicom Group, a leading global marketing and corporate communications company. Omnicom’s branded networks and numerous specialty firms provide advertising and communications services to over 5,000 clients in more than 70 countries. Omnicom Global Solutions India plays a key role for our group companies and global agencies by providing stellar products and services in the areas of Creative Services, Technology, Marketing Science, Media Services, Market Research and Business Support Services Let us build this, together! Flywheel operates a leading cloud-based digital commerce platform across the world’s major digital marketplaces. It enables our clients to access near real-time performance measurement and improve sales, share, and profit. Through our expertise, scale, global reach, and highly sophisticated AI and data-powered solutions, we provide differentiated value for both the world’s largest consumer product companies and fast-growing brands. Work Timings - 2pm - 11pm Work Location - Bangalore Responsibilities Roles and Responsibilities: Responsible for checking 100% of data updates before loading into the Client Database. All errors identified to be rectified Use attention to detail to spot any errors in the data and take appropriate measures to fix them Train new hires and provide ongoing training and capability building sessions Handle client and internal queries – answer customer enquiries and resolve customer issues in an efficient and timely manner Managing weekly workload across the team for retailer updates and client queries Ensuring retailers are being updated annually / quarterly based on their tier and to agreed schedule Updating and agreeing with the Flywheel data lead weekly priorities Understanding quality expectations from Flywheel and delivering through team briefings and quality control checks Reporting on retailer models delivered and quality achieved on a weekly and monthly basis to the Flywheel data lead Qualifications This may be the right role for you if you have. Experience in data analysis with proficiency in Excel (experience with Excel models is a plus). Strong analytical and logical thinking with the ability to make basic revenue estimates and explain the methodology clearly. Excellent numeracy skills with a keen eye for accuracy and precision. Commitment to quality — attention to detail, persistence, and the ability to follow through on tasks. Strong verbal and written communication skills to convey insights effectively. Passion for delivering highly accurate data and maintaining data integrity. Strong research abilities — capable of analysing company-reported data, identifying key insights, and sourcing relevant information. Interest in global retail, ecommerce, and company performance trends. Problem-solving mindset — able to identify challenges and proactively seek solutions. 2-3 years of professional experience in a relevant role. Ability to work independently with minimal supervision while taking ownership of tasks. Quick learner with the adaptability to pick up new skills and tools efficiently.

Should be capable of handling QC activities like analysis of samples related to Raw material, In process, Intermediate, Finished products, stability samples and calibration with different techniques like wet and instrument. Should be handled the instruments like KF, IR, UV, HPLC, GC Should have the knowledge of GLP , GDP and c GMP practices.

Make your ability count at NNE . We are experts in end-to-end pharma engineering and our success is built on our relationships, both with our colleagues and our customers. If you want to work on projects shaping the future of sustainable and intelligent pharma facilities, NNE is the place to be. Work with us Are you NNEs next Project Planner? You have experience in planning of large project and have eagerness to learn about pharmaceutical engineering processes, you might be the person we need. You will be a part of a dynamic team of 45 experienced professionals in the department of Project Management. You will receive the training and support needed to become an excellent senior project planner in the complex field of biotech and pharmaceuticals. The job requires a strong understanding of project planning procedures and excellent communication skills as you will be responsible for project planning activities in all phases on large multi-disciplinary projects. Furthermore, you will be a key player in ensuring that important projects are executed within time and that GMP requirements are implemented as a seamless part of the planning process. Lastly, you will also be involved in developing and implementing the procedures and tools that will enhance the department s ability to support excellent project execution. For the right candidates there will be possibilities for business travels or relocation to Denmark. Seniority 8-10 yrs. Job functions Project Planning Employment type NNE India Employee Department Project Department Management Location NNE India, Bangalore How you might spend your days As a Project Planner, youll be working with an innovative, multi-disciplinary team where, To drive the creation of project time schedules at all levels with assistance from other project members. To be able to identify solutions to time schedule constraints to meet overall requirements on time. To advice project manager/project director and be an active part of the project management team To evaluate and register progress and earned value on tasks and to estimate time/work to finish. & to assist in taking corrective actions in case of delays. To assist in evaluating time schedules and progress reports from sub-suppliers To supply schedule and progress data to any project reporting required. Who you are At NNE, we care about who you are as a person. Ultimately, how you work, and your energy is what impacts the work we do as a team. As a person, you You have an education as engineer or similar You have a minimum of 8-10 years of planning experience from an engineering or manufacturing company You are proficient in Primavera P6 and Microsoft Project You are a team player with great communication skills and ability to communicate with different levels in the organization. You are flexible and have experience from a similar role within pharmaceutical, biotech, food or chemical industries. You are result-oriented and have a well-structured approach to your work The miles you ve walked To apply for the position there are some things that are needed, and others a bonus. We believe these qualifications are need-ed for you to succeed in this role: Degree in Quantity Surveying, Engineering, Construction Management, or equivalent. Experience with using the planning tools Microsoft Project and Primavera P6 Experience with using various planning types: Network diagrams, Gant charts, etc. Experience from the pharmaceutical, biotech, food or chemical industry. Strong ability to create structures. Have the ability to handle several projects simultaneously. Communication skills in English, written and oral Continuously maintain an accurate schedule providing decisions information to project management We re experts bound by a noble cause and driven by passion NNE is short for Novo Nordisk Engineering. And for all of us who work here, NNE means so much more. Some of us are driven by working on highly complex projects together with other leading experts. Others are inspired by a work environment with flat hierarchy and flexible conditions. And some love the fact that they work for a world leading engineering consultancy within the pharma industry. If theres one thing, we all share, its the passion for what we do. Together we design and build pharma facilities that are essential for millions of patients all over the world. Sounds like something you d like to do? If you re ready to unleash your potential, let s have a talk. Deadline of application is 20th March 2025 Questions before applying? Please contact pvyn@nne.com or RHM@nne.com We will invite to interviews on a running basis.

- Experience of Calcium Lactobionate Manufacturing - Responsible for preparing work instruction for Production and manufacturing activities - Maintain online documentation related to production activities like BMR, BPRs, logbooks and daily records. Required Candidate profile Relocation from Maharashtra only - Qualification of production equipment and participation in validation activities - Maintaining documentation such URS, DQ, IQ, OQ, PQ validation protocol with report

Job Description Position Summary: Ensure the client receives quality data in a timely manner by reviewing laboratory documentation, generated data, calculated results, and final reports for accuracy, clarity, and adherence to GMP and/or GLP regulations, and evaluating problems/system failures to achieve efficiency gains Essential Duties and Responsibilities: Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Review simple and complex routine and non-routine data (for 3 or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; make sure all work is performed according to GLP/GMP requirements; perform complex calculations Communication in writing and in person with laboratory personnel in an intelligent and clear manner Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, integration review, compound evaluation, chemical identification, and other subjective review based on testing performed; perform complex calculations to verify results Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology May serve as technical advisor for analysts with regard to QA/QC of data Diagnose problems; solve simple problems, and suggest solution to complete problems in professional area Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employees Use MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulas Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications M.Pharm (Pharmaceutical Analysis)

Job Description Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications M.Pharm (Pharmaceutical Analysis) / M.Sc Chemistry

Role & responsibilities Follow good hygiene practices as per approved Food Safety Standards”. Management of Audit and Compliance. Prepare and Review of documents related to FSSC 22000 and its implementation. Review of SOPs in E-DMS. Review of Change control, Deviation, Incidents. Food Safety Meetings/Quality management Systems Meeting and Trainings. Preform Internal auditing and External Auditing. Provide the trainings to subordinates. To ensure the compliance of E-QMS. To prepare the document w.r.t ESG requirement. Ensuring audit coordination with coordination with customers/ regulatory/ in-House/ vendor as per schedule, audit CAPA & closure.

Position Summary: Ensure the client receives quality data in a timely manner by reviewing laboratory documentation, generated data, calculated results, and final reports for accuracy, clarity, and adherence to GMP and/or GLP regulations, and evaluating problems/system failures to achieve efficiency gains Essential Duties and Responsibilities: Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Review simple and complex routine and non-routine data (for 3 or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; make sure all work is performed according to GLP/GMP requirements; perform complex calculations Communication in writing and in person with laboratory personnel in an intelligent and clear manner Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, integration review, compound evaluation, chemical identification, and other subjective review based on testing performed; perform complex calculations to verify results Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology May serve as technical advisor for analysts with regard to QA/QC of data Diagnose problems; solve simple problems, and suggest solution to complete problems in professional area Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employees Use MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulas Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns Conducts all activities in a safe and efficient manner Performs other duties as assigned

Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned

Roles and Responsibilities Conduct quality control analysis using HPLC, GC, UV, spectrophotometer, sterile techniques, and other relevant methods. Ensure compliance with USFDA, GMP, GLP regulations during regulatory audits. Develop and maintain SOPs for laboratory operations and testing procedures. Collaborate with cross-functional teams to resolve quality issues and improve processes. Perform stability studies on APIs and finished products as required. Desired Candidate Profile 2-7 years of experience in a pharmaceutical industry setting with expertise in QC analysis. MS/M.Sc(Science) degree in Chemistry or related field; Strong understanding of analytical instruments such as HPLC, GC, UV spectrometer etc., and ability to operate them effectively.

Role & responsibilities : 1. Testing of Samples. 2. Handling instruments such as HPLC, GC, UV Spectrophotometer, etc. 3. Development of Analytical methods for various formulations. 4. Validation of Analytical methods. 5. Preparing analytical method development reports. 6. Method Transfer. 7. Literature survey for existing analytical methods on Internet. 8. Carry out literature survey by establishing the strategies. 9. Pre-formulation sample analysis. (Solubility, Force-degradation, photo stability etc.) 10. Drug Excipient Compatibility Sample Analysis. 11. Trial batch Analysis. 12. Trial batch Stability sample analysis. 13. Reference product Analysis. 14. Prepare cGLP/cGMP documents. 15. Maintenance of reference standard, working standards and their standardization. 16. Coordinating the activities in Chemical and Instrumentation. 17. Analytical Method Development and handling of Troubleshooting. 18. Preparation and Review of Raw Material, Packing Material, Finished Product Release Specification and Standard Test Procedure. Analysis of Raw Material, Packing Material & Finished Products. Performing quality control activities as per daily analysis plan. Preferred candidate profile: 7 to 8 years of relevant experience in Pharma Formulation Plant. Perks and benefits: Best in Industry

Recruiter Mohaneswara Reddy https://www.linkedin.com/in/mohaneswarareddy Role & responsibilities The responsibilities are Operations, Control and Monitoring 1. Improving, continuous reviewing and up gradation of existing production SOPs and work systems to ensure their strict implementation in respective block. 2. Resolution and identification of maintenance related activities of equipment and facility and making sure those are closed appropriately 3. Executing proposed changes in product, process or equipment and facility. 4. Preparing production plan and supervising the API and Intermediate batches as per production plan. 5. Ensure facility upkeep is maintained all the time. 6. Any other assignment given by management. 7. Communicating concerns with cross functional and service departments. 8. Control and monitor departmental opex budget. 9. Monitoring and controlling of effluent generation from manufacturing block. 10. Periodic review and monitoring of inventory in coordination with unit stores and supply chain. 11. Executing and monitoring of validation of new product, CIP, AVD with the help of cross functional team. 12. Implementation of new technology w.r.t. process equipments or facility. 13. Supporting quality assurance team for DMF submission. 14. Executing and supervising training, validation, qualification and calibrations protocols. 15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure. cGMP: 1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements. 2. Making sure all the documents and checklist are verified before and after manufacturing. 3. Ensuring retention and destruction of records are maintained in a department. 4. Verifying status labelling of accessories, in-process instruments, containers, area & equipment 5. Performing contemporaneous (on time) document entries. QMS / OTHER SOFTWARE SYSTEMS: 1. Operating software systems like SAP, Quality Management System, Track wise system, Cipdox software, PR approval, LMS, Ariba, PPDS and E-Track system etc. based on roles and rights provided in the applications. 2. Compiling Annual product quality review along with quality assurance department and other CFT. 3. Participating and contributing to investigation for any non-conformance along with CFT. EHS: 1. Following Environment, Health and Safety policies and practices. 2. Making sure personnel health, hygiene and organisation practices are followed. 3. To conduct risk analysis of product, system, equipment, process as per standard procedure. Training 1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS). Energy Management system (EnMS) 1. Participating in EnMS audits & Leadership rounds. Preferred candidate profile B.Tech Chemical with minimum 10 years of API production experience including experience to handle a block/section in a API plant.

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our new Sandoz! Is responsible at global (Divisional) level to define the procedures and processes for successful implementation of product technical transfers either from development to production or between production sites including ESO. Collaborate with sites and CMO s to provide direction and support to ensure the robustness of technical aspects of technology transfers by implementing QbD principles. Job Description Your Key Responsibilities: Your responsibilities include, but not limited to: Establish the global (Divisional) requirements of a technical transfer protocol of relevant information related to materials, analytical methods, premises and equipment, process flow and steps, packaging, HSE, cleaning validation addressing the following technical aspects: o Manufacturing Process Transfer Documentation o Process flow diagrams, IPC tests, process parameters and ranges o Technical, clinical and regulatory batches at site. o Monitoring and continued process verification. o Defining hand-over criteria e.g. number of batches, process capability (Cpk), etc. o Concurrence to all current applicable standards (cGMP, HSE, Regulatory etc.). Establish and manage system to provide the above technical aspects during transfer between sites. Provide technical expertise, as required, with Process Support Leads, Technical Stewards, Product Stewards, Validation Lead during manufacturing of transfer trials or batches. Support continuous process and quality improvements through the development and management of global technology transfer metrics. Provide periodic reporting to Development, Divisional Tech Ops and Quality Assurance leadership on technical transfer activities and performance. Support local sites, as needed, during Compliance audits, when technical transfer activities are evaluated. Develop and manage systems to ensure that lessons learned during the transfer of technology on a site level are applied globally. Work with the local sites and Development to establish performance objectives related to technical transfer activities. What you ll bring to the role: Minimum Requirements: Educational Background: Masters in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent technical / scientific degree. Languages: Fluent in English Experience: Minimum 10 - 15 years experience in pharmaceutical manufacturing, of which 5+ in a product transfer or project management position and 2+ years mid to high level management experience. Comprehensive know-how in pharmaceutical technology Proven process understanding (Pharma, GMP, Regulatory aspects). Sound experience of data handling and applied statistics. Demonstrated leadership and accomplishments in a global/matrix environment in the pharmaceutical industry Demonstrated interpersonal, communication, negotiation and problem solving skills

1. Responsible for reviewing, approving and distributing work instruction for manufacturing activities. 2. Carry out production activities as per production plan. 3. Review online documentation related to production activities BMR, BPRs, logbooks

PRINCIPAL ACCOUNTABILITIES (List the accountabilities associated with the job.) Work on assigned UAT testing as per call priority and get it complete within timeline UAT completion/feedback shared to IT team and get it rectify, take followup with developer to clear testing GC calls UAT completion/feedback shared to IT team and get it rectify, take followup with developer to clear testing Testing of the calls as per FTC’s, zero bug on production All LOB calls UAT completion/feedback shared to IT team and get it rectify, take followup with developer to clear testing Prepare SOP & share the same with SPOC for circulation Circulate the report to stakeholders Another task assigned by senior Ensure deadlines are met within established targets for different work processes in lines with the organization guidelines Test / Retest all assigned scenarios Determine if assigned scenarios pass or fail and record findings on the scenario tracker Provide detailed description of scenarios that failed Attend scheduled test sessions and, if needed, attend overflow sessions to complete all assigned scenarios May suggest additional test scenario to be added to the Scenario tracking document Communicate suggestions or concerns regarding testing with the functional test lead Testers involved in multiple testing sessions should reach out to Functional Leads to find out which session to attend MAJOR CHALLENGES (Describe the major challenges you face on an on-going basis in carrying out your job.) Not Applicable. It’s a new team which has been formed which will be DECISIONS (Mention the key decisions taken by job holder at his end and the decisions for which the job holder goes to superior with options and recommendations or seek approval). INTERACTIONS (The key working relationships or routine contacts a job holder needs to have INSIDE and OUTSIDE the organization to accomplish the job.) Internal Clients Roles you need to interact with inside the organization to enable success in your day to day work All Business owners & CoEs External Clients Roles you need to interact with outside the organization to enable success in your day to day work No DIMENSIONS (List the significant numerical data which will reflect the scope and scale of activities concerning this job). Financial Dimensions (These should be quantifiable numerical amounts like annual budgets, project costs, annual revenue, purchase value etc.) . Other Dimensions (Indication of some of the significant volumes associated with the job like number in team/ staff handled etc). Total Team Size: 11 – Proposed with the new structure Number of Direct Reports: 4(Existing) Number of Outsourced employees: None SKILLS AND KNOWLEDGE (State the minimum acceptable proficiency for this job which best indicates the education and/or experience requirements of this job and not the incumbent). Educational Qualifications Qualifications Minimum Qualification: Graduate with General Insurance knowledge is Must Work Experience 1-2 years in same role Roles and Responsibilities 2

PRINCIPAL ACCOUNTABILITIES (List the accountabilities associated with the job.) Work on assigned UAT testing as per call priority and get it complete within timeline UAT completion/feedback shared to IT team and get it rectify, take followup with developer to clear testing GC calls UAT completion/feedback shared to IT team and get it rectify, take followup with developer to clear testing Testing of the calls as per FTC’s, zero bug on production All LOB calls UAT completion/feedback shared to IT team and get it rectify, take followup with developer to clear testing Prepare SOP & share the same with SPOC for circulation Circulate the report to stakeholders Another task assigned by senior Ensure deadlines are met within established targets for different work processes in lines with the organization guidelines Test / Retest all assigned scenarios Determine if assigned scenarios pass or fail and record findings on the scenario tracker Provide detailed description of scenarios that failed Attend scheduled test sessions and, if needed, attend overflow sessions to complete all assigned scenarios May suggest additional test scenario to be added to the Scenario tracking document Communicate suggestions or concerns regarding testing with the functional test lead Testers involved in multiple testing sessions should reach out to Functional Leads to find out which session to attend MAJOR CHALLENGES (Describe the major challenges you face on an on-going basis in carrying out your job.) Not Applicable. It’s a new team which has been formed which will be DECISIONS (Mention the key decisions taken by job holder at his end and the decisions for which the job holder goes to superior with options and recommendations or seek approval). INTERACTIONS (The key working relationships or routine contacts a job holder needs to have INSIDE and OUTSIDE the organization to accomplish the job.) Internal Clients Roles you need to interact with inside the organization to enable success in your day to day work All Business owners & CoEs External Clients Roles you need to interact with outside the organization to enable success in your day to day work No DIMENSIONS (List the significant numerical data which will reflect the scope and scale of activities concerning this job). Financial Dimensions (These should be quantifiable numerical amounts like annual budgets, project costs, annual revenue, purchase value etc.) . Other Dimensions (Indication of some of the significant volumes associated with the job like number in team/ staff handled etc). Total Team Size: 11 – Proposed with the new structure Number of Direct Reports: 4(Existing) Number of Outsourced employees: None SKILLS AND KNOWLEDGE (State the minimum acceptable proficiency for this job which best indicates the education and/or experience requirements of this job and not the incumbent). Educational Qualifications Qualifications Minimum Qualification: Graduate with General Insurance knowledge is Must Work Experience 1-2 years in same role Roles and Responsibilities 2

Position- Junior/ Senior Production Executive Work Experience +3 in API Location Mysore MSc (Chemistry)/ BE (Chemical) Job Description 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by Production head. If interested, kindly send your updated resume on jyotsna@avaniconsulting.com or whatsapp@7780363938

Role & responsibilities Relevant Experience : Should have experience of Production for Formulation Plant of Oral Solids (Tablets, granules, powder) & Allied in PHARMACEUTICAL COMPANY / FACTORY. FDA Approval in Tablet Section Pharma Formulation plant would be preferred. 1. Batch Manufacturing Manufacture production batches as per Batch Manufacturing Record (BMR) and Batch Production Record (BPR). 2. BMR/BPR Documentation Complete the online BMR and BPR as per the respective activities. 3. Coordination with QA Coordinate with the Quality Assurance (QA) department for the issuance of monthly formats. 4. Manufacturing Parameters Review Review parameters during manufacturing stages such as compression, filling, and packing for oral dosage products. 5. SOPs and Documentation Prepare, update, and maintain Standard Operating Procedures (SOPs), BMR, and BPR documents. 6. Document Maintenance Ensure proper maintenance of documents, including BMR, BPR, cleaning records, calibration logs, environmental records, and equipment usage logbooks. 7. Manpower Allocation Allocate and manage manpower for the effective utilization of resources. 8. Production and Packing Oversight Oversee and manage the overall manufacturing and packing activities in the oral department. 9. Compliance with cGMP & GDP Monitor and implement Current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP) within the department. 10. Quality Management System: Handle the Quality Management System (QMS), including initiating, investigating, and completing change control, deviations, and incidents. 11. Equipment & Area Qualification: Monitor and review equipment and area qualification activities and ensure timely reporting. 12. Validation Activities Coordinate with QA and QC departments for product process validation and cleaning validation activities. 13. Production Target Achievement Ensure daily and monthly production output targets are achieved. 14. Cross-Department Coordination Facilitate coordination between Quality Assurance, Quality Control, Warehouse, and Engineering departments. 15. Material Availability Check Ensure availability of required raw materials (RM) and packaging materials (PM) as per the production plan and schedule. 16. Training & Development Conduct training programs on SOPs, GMP, technical procedures, and identify training needs for department personnel. 17. BMR/BPR Handover to QA Ensure completed BMR and BPR are handed over to the QA department before dispatch activities. Required Candidate profile: 1. 07-10 years of experience in Formulation Pharmaceutical Plant. 2. Relevant Experience in Pharma formulation plant. 3. Computer proficiency in MS Office, Excel, e-mail and internet functions, ERP

Role Description: The Associate Consultant works within the Regulatory, Quality & Compliance team to contribute to the regulatory, quality, and compliance consulting practice. The Associate Consultant is responsible for the preparation and submission of GMP Clearance applications as well as a range of compliance documents or related quality activities. The Associate Consultant also supports the delivery of a variety of projects, working closely with the Regulatory, Quality & Compliance Administrators, Associates, Associate Consultants, Consultants, Senior Consultants, Manager, Senior Manager, and/or Head of Business Unit to deliver a superior client experience and optimize project outcomes. Role Responsibilities: Adherence to ProductLife Group s values, policies, and quality management systems. Perform compliance activities to meet ProductLife Group and client Quality objectives. Support audit requests as required. Manage and prepare GMP clearance applications for submission to the TGA and/or other regulatory agencies, as required. Provide regulatory, quality, and compliance support to clients relating to the registration/listing of pharmaceuticals, biologicals, and medical devices and the ongoing maintenance of these. Assist clients in responding to agency questions. Provide support to clients by assisting more senior members of the team with regulatory, quality, and compliance activities. Prepare, review, and update quality documentation. Provide high-quality work that contributes to client satisfaction and loyalty, leading to the optimization of repeat business and expansion of service provision across the Regulatory, Quality & Compliance service offering. Qualifications / Experience / Skills: Undergraduate qualifications in the pharmaceutical sciences or other scientific discipline. A minimum of 3 years of experience in Australian and New Zealand Quality or Regulatory Affairs, preferably in a commercial environment. Good knowledge of TGA and Medsafe legislation, regulations, guidelines, and working procedures is preferable. Reasonable computer literacy. Proven experience dealing with a high level of confidentiality. Good problem-solving and project management skills. Ability to work to deadlines. Attention to detail. Excellent written and spoken communication and interpersonal skills. Interest in the practice of consulting. An appetite for learning and development.

Role & responsibilities You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company. Key Deliverables: 1. Ensure manufacturing practices as per cGMP and GLP standards. 2. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc. 3. Applications for AHC to AQCS, EIA and Capexil and coordinate related activities. (AHV/SPD: This is exclusive knowledge related to Capsule and companies manufacturing animal origin products. We have mentioned this as the candidate on joining will be responsible for this work though he/she may not be having exposure to same.) 4. Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits. 5. Ensure all personnel are trained on requirements for GMP, GLP, GDP, applicable regulatory issues and other procedures related to their work area. (SBG) 6. Evaluation and approval of Suppliers for RM, PM, testing labs and service providers. 7. Assisting HOD in customer complaint analysis and preparation of customer complaint report. 8. Investigation of incidents, deviations, OOS and ensure corrective actions in place. 9. Reviewing the daily availability of operators and allocating work to them. 10. Maintaining and review BMR documents, guide for relevant changes if required. 11. Label artwork review and management. Technical Competencies: a) Analytical skills (spotting trends and patterns) b) Report writing skills c) Problem solving abilities d) GMP and GDP knowledge e) Good English communication skills (verbal & written). Behavioural Competencies: a) Quality and Service Orientation b) Delivering consistent results c) Ability to prioritize, organize, manage work and time. d) Customer Centric e) Cross Functional Team Working Preferred candidate profile B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology) 8+ Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries. Perks and benefits 1. Opportunity to be part of a growing organization offering niche products to Pharma industry. 2. Opportunity to work at Head Office location. 3. Intimate small company culture with MNC professionalism. 4. Company value programs TrANSSCEnD. 5. Employee events like festival celebrations, family fun events etc. 6. Five days working (alternate weeks). 7. Medical Insurance for your immediate family. 8. Housing accommodation for Bachelors & family.