291 Cgmp Jobs - Page 9

Role & responsibilities Trainee Production Chemist Preferred candidate profile B.Sc or M.sc 2024-25 passout candidates willing to work in Production Departmant only can apply .

Raise laboratory Change control, incidents, deviations and LI wherever applicable. Review of Instrument qualification and scheduled calibration planner. Ensure proper laboratory analysis as per MOA and current product specification.

Handle BMR and batch repacking records, Verify daily balance checks and calibration activities, Maintain production records, Perform and verify line clearance at manufacturing and packing stages, Issue and retrieve production documents Required Candidate profile Graduate candidates with 2-5 Year experience and knowledge about cGMP Practice, QMS tools knowledge, Production and Manufacturing documentation process. We are looking for local candidates ONLY.

The Apex Group was established in Bermuda in 2003 and is now one of the worlds largest fund administration and middle office solutions providers. Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion. Thats why, at Apex Group, we will do more than simply empower you. We will work to supercharge your unique skills and experience. Take the lead and well give you the support you need to be at the top of your game. And we offer you the freedom to be a positive disrupter and turn big ideas into bold, industry-changing realities. For our business, for clients, and for you The Role: Understand the global outsourcing policy and framework and support the Global Outsourcing Team in ensuring the business comply with this and supporting in annual refresh of policy and process. To join regular calls and meetings with the Global Outsourcing Team to shadow and learn the business and operating model from an outsourcing perspective. Support the regulated businesses across Apex with maintenance of the Nexus Assurance Navigator system. Take responsibility and ownership of Nexus Navigator and validation and integrity of data within. Work with various technology stakeholders across the business to ensure there is accurate and seamless data feeds and support with development of reporting in and out of the platform. At as project manager for any system, data or reporting projects and initiatives Support the regulated businesses across Apex with Outsourcing tasks within the platform Perform analytics on data outputs Create reports from excel outputs and support with development of dashboards to present data Support the India Outsourcing Lead, GSC and local businesses with maintenance of the Nexus Assurance Navigator system and to support with preparation of reports. Support the India Outsourcing Lead and Local MGT with amending, preparing and reviewing outsourcing spreadsheets Support the India Outsourcing Lead and Local MGT with signing of all outsourcing documents and uploading into the system Support with Nexus Assurance on-going development and system enhancement projects. Act as super user on Nexus, providing support globally and over time supporting with delivering training and guidance on the system Support with various outsourcing projects with internal stakeholders. Maintaining outsourcing registers in excel and on systems. Preparing and presenting quarterly and ad-hoc reporting packs. Assisting in audits including internal audits and risk assessments and reviews from an outsourcing perspective. Maintaining and updating trackers internally and ensuring data integrity and confidentiality of internal information. Be a member of the Global Outsourcing working group and take part in joining each of the initiatives/project teams that this group are tasked with. Preparation of annual due diligence reports Quality assurance and control The Skills: Strong communication and drafting skills including drafting of presentations and reports and supporting in writing policies and procedures Ability to learn and grasp new compliance/risk/regulatory concepts and understanding these across multiple global jurisdictions within the business. Strong work ethic. Adapting and flexible approach towards learning new systems and operational procedures. Ability to work under pressure and tight timelines, excellent time management and multi-tasking skills. Strong interpersonal, verbal and non-verbal communication skills. Team Player with excellent collaborative, analytical, problem solving and organisational skills. Result oriented, detail oriented, team player with ability to work effectively with minimum supervision, in a fast paced, complex and dynamic environment. Very strong MS Office skills (including MS Excel Outlook, MS Word, MS PowerPoint) DisclaimerUnsolicited CVs sent to Apex (Talent Acquisition Team or Hiring Managers) by recruitment agencies will not be accepted for this position. Apex operates a direct sourcing model and where agency assistance is required, the Talent Acquisition team will engage directly with our exclusive recruitment partners.

Sodexo Food Solutions India Pvt. Ltd.ces is looking for MIS & Admin Assistant to join our dynamic team and embark on a rewarding career journey Oversee the design, implementation, and maintenance of the information systems, including hardware, software, and networking infrastructure Manage the database systems, including data backup and recovery, data security, and data integrity Develop and maintain procedures for managing the information systems and technology infrastructure, including disaster recovery plans, security policies, and user access controls Analyze the business processes and identify opportunities for improvement through the use of information systems and technology Collaborate with cross-functional teams, including IT, finance, and business operations, to integrate information systems and technology with other systems and processes Monitor system performance and provide technical support to end-users to ensure the smooth operation of information systems and technology Strong analytical and problem-solving skills Excellent communication and collaboration skills

Role & responsibilities Regulatory Strategies & Submissions: Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs. Preparing and submitting regulatory documents like Drug Master Files (DMFs) and marketing authorization applications (MAAs) to regulatory bodies. Preparation and Compilation of dossiers in CTD & eCTD. Collaborating with cross-functional teams to address regulatory queries in a timely manner. Responsible for end-to-end filing of New products (Actives / Fixed Dose Combinations / Nutritional supplements etc.) in CDSCO (Central Drugs Standard Control Organization), FSSAI, State FDA and other regulatory bodies. Filing application of ND/SND/FDC/Import Registration/Import license etc. on SUGAM portal. Track and interpret evolving regulatory requirements and assess their impact on ongoing projects. Collaborate with marketing and business development to support go-to-market strategies, portfolio expansion. Compliance & Change Control: Ensuring that manufacturing processes meet all relevant regulations and guidelines. Assessing and managing the regulatory impact of changes to manufacturing processes. Review of technical documents, Change controls Gap analysis for variation filing and maintaining product Life cycle. Collaborating with cross-functional teams, such as R&D, QA, and manufacturing, to ensure regulatory compliance. Audits and Inspections: Preparing for and supporting regulatory audits and inspections across various contract manufacturing sites. Ensuring that corrective actions are implemented in a timely manner with respect to Audit findings and that any necessary documentation is updated in a systematic manner. Others: Staying up-to-date with current FDA / FSAAI regulatory requirements and guidelines for APIs and Finished formulations. Provide regulatory support to QA-AC for IPC/CDTL/CDL testing Providing regulatory support for new product development. Key Result Areas: Manage proactive and professional delivery of results for the regulatory activities of all the products to support the business goals Ensure a high scientific standard and quality for all regulatory documents Monitoring and ensuring that both API manufacturing and Finished formulations production adhere to all applicable regulations. Preferred candidate profile B-Pharma or M-Pharma Minimum of 8 to10 years of experience in regulatory affairs in pharmaceutical industry, With at least 3 to 4 years in a managerial role. Strong understanding of pharma regulatory framework. Excellent communication and multi-tasking skills Location Mumbai HO / Regular visits to various Contract Manufacturing sites Department Regulatory Affairs

Job Description: Head of Quality Experience: 15 Years or more Location: Udaipur About Macsen Drugs: Macsen Drugs is a USFDA registered, WHO-GMP certified, TGA GMP certified, and EU GMP (Written Confirmation) certified manufacturer of active pharmaceutical ingredients or bulk drugs for varied therapeutic applications like antidote, urinary antiseptic, topical antiseptic, ophthalmic diagnostic, anti-dandruff, anti-acne, and several other applications. Job Overview: We are seeking an experienced and detail-oriented individual to perform research activities as designing and conducting scientific experiments, analyzing and interpreting results, leading to significant value to the process development. Efficient contribution to the overall success of the research & development team performance according to objectives and targets set by the Management. Responsibilities: 1. Quality Assurance (QA) Develop and implement a comprehensive Quality Management System (QMS) compliant with cGMP and ICH guidelines. Review and approve quality documents such as SOPs, batch records, deviations, and CAPA reports. Ensure the site is prepared for regulatory audits and inspections from the USFDA, EMA, WHO, and other agencies. Conduct internal audits and self-inspections to maintain quality standards. 2. Quality Control (QC) Oversee laboratory operations, ensuring raw materials, intermediates, and finished products meet established quality specifications. Manage analytical method validations and stability studies. Monitor calibration and maintenance of laboratory instruments. 3. Regulatory Affairs Prepare and submit regulatory documents, including DMFs, for US and international markets. Address regulatory queries and implement corrective actions for observations from audits or inspections. Stay updated on global regulatory trends and ensure compliance with evolving requirements. 4. Production Oversight Collaborate with production teams to ensure manufacturing processes align with quality standards. Oversee cleaning and process validation for a multi-product facility to prevent cross-contamination. Troubleshoot production and analytical challenges in coordination with R&D. 5. Data Integrity and Security Ensure compliance with 21 CFR Part 11 for electronic records, signatures, and data integrity. Establish protocols for data security and governance across all quality operations. 6. Cross-Functional Coordination Work with R&D and Analytical Development Labs for seamless technology transfer and method development. Collaborate with Stores and Maintenance teams to ensure proper inventory management and equipment validation. Coordinate training programs for team members to maintain high-quality standards. 7. Leadership Lead and mentor teams across QA, QC, Regulatory, Production, and Maintenance departments. • Foster a culture of quality, accountability, and continuous improvement. 1. Educational Qualifications Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field. Additional certifications in Quality Management Systems (e.g., ISO 9001, Six Sigma) are preferred. 2. Experience Requirements Minimum 15 years of experience in API manufacturing, with at least 5 years in a leadership role managing QA, QC, and Regulatory Affairs. Proven experience in handling audits and inspections by regulatory agencies such as USFDA, EMA, WHO, or PICS. Hands-on experience in managing multi-product facilities with cleaning and process validation expertise. How to Apply: Send your updated resume to hrd@macsenlab.com

Hi, Greetings Walk in Invitation: We are having face to face interview on 14th June Saturday in Mysore.- Single Round Company : A leading Pharma API Unit - in Mysore Position - Production Department Associate Work Experience Min 3 yrs in API in current Salary 20% to 25 % hike on current CTC. Note: No Charges If interested drop your CV to Priyanka Palit [ 9518220852 || priyanka@avaniconsulting.com ] Thanks & Regards Priyanka Palit

Role & responsibilities Should have knowledge of SLD drawing Should be able to read the Electrical and Mechanical Drawing. Should be able to understand of P&ID and isometric Drawing. Basic knowledge of AutoCAD Hands on experience of Budget preparation of project work. Hands on experience on Project planning, handling and management. Should have able to manage material stock and record for consumption sheet preparation. Understand Companys Health & Safety Policy and follow all company HSE procedures. Should able to deliver the assigned task on time. Finalization of technical specification of machine Hands on experience on documentation like OQ,IQ,URS etc. Hands on experience of execution and commissioning of pharma machineries and utility Equipments Should have knowledge of HVAC system and clean room applications Should have knowledge of CGMP and revised schedule M Hand on experience of solid oral facility (Nutraceutical experience also be considered)Hands on Experience of WTP/utilities (Boiler, Chiller, WTP, Compressor, ETP, STP) piping, installation and commissioning. Hands on experience of vendor co ordination Should be able to present Project status/ reports and Daily work status/report. Manpower handling Hands on experience on Facility qualification, HVAC and Compressed Air Validation Provide technical input as required to ensure projects progress in line with their scope requirements. Support the development and completion of documentation in relation to purchasing, planning, implementation, commissioning and validation activities in relation to the above. Be responsible for Supervision of 3rd party contractors and internal service providers Be responsible for tracking and reporting project delivery, ensuring projects are delivered on time and within budget. Ensure training has been Given before undertaking specific duties and that all training is recorded in training records. Preferred candidate profile 5-7 years of hands-on experience in project engineering or project management roles within OSD pharmaceutical manufacturing . In-depth knowledge of OSD manufacturing processes , equipment, utilities, and facility layouts. Familiarity with HVAC , cleanroom classification, and GMP /cGMP requirements. Hands-on experience with equipment installation, commissioning, and qualification (IQ/OQ/PQ).

Stedman Pharmaceuticals is looking for a dynamic and experienced candidate for the Quality Control (QC) department with hands-on experience in Analytical Method Validation for various dosage forms. Resume to hrd@stedmanpharma.com / 9786920463

Job summary We are seeking an individual to test samples and release results within Turnaround Time (TAT) for commercial and stability batches, adhering to GMP (Good Manufacturing Practices). This role involves calibrating and maintaining assigned equipment within departmental and organizational guidelines, processes, and procedures. The primary objective is to ensure accuracy in results provided within timelines. Roles & Responsibilities • Your responsibilities encompass testing assigned samples and releasing data within defined timelines, ensuring absence of executional errors against established procedures. You will be responsible for preparing required reagents and buffers in alignment with the testing plan and ensuring the availability of equipment for analysis. • Your role involves documenting activities contemporaneously, adhering to Good Documentation Practices and compliance expectations, and conducting self-checks post-analysis to ensure accuracy. • You will promptly inform the supervisor about risk actions, providing necessary data and analysis to support the investigation process. You will adhere to QMS (Quality Management systems) and closure timelines, actively participate in laboratory investigations and discrepancy closures, fulfilling defined roles in audits. • Your responsibilities also include ensuring lab cleanliness, proper sample storage, chemical labeling, removal of expired material, usage of calibrated equipment, equipment calibration, maintenance, and qualification. • You will address instrument-related issues and conduct root cause analyses (RCAs) for unknown problems, and play a crucial role in training new team members on analytical techniques. Qualification Educational qualification: An M.Sc., M.Tech. or B.Tech. in Microbiology, Biochemistry, or Biotechnology Minimum work experience : 2 years Skills & attributes: Technical Skills • Basic understanding of the Biologics/Biosimilar industry, including processes, regulations, and trends. • Hands-on experience in High-Performance Liquid Chromatography (HPLC) techniques, including Size Exclusion, Reverse Phase, Ion Exchange chromatography, and Peptide mapping analysis, especially within the context of Analytics. • Hands-on experience in Biochemical analysis techniques, specifically Electrophoresis, Enzyme-Linked Immunosorbent Assay (ELISA), and Polymerase Chain Reaction (PCR), with a focus on Analytics. • Working experience in a cGMP (Current Good Manufacturing Practice) environment, with a special emphasis on Good Documentation Practices (GDP). • Basic knowledge in protein chemistry, including an understanding of protein structure, function, and relevant analytical techniques. • Basic knowledge and hands-on exposure to Microbiology techniques, particularly relevant for individuals working in Microbiology Labs. • Basic knowledge and hands-on exposure to cell culture techniques, specifically for working in Bioanalytics (BA) Labs. Behavioural skills • Prioritizes effective communication and demonstrates a performance-oriented mind-set. • Effective verbal and written communication skills. • Performance-oriented approach, consistently striving for high standards. • Demonstrates flexibility in working shifts and a clear understanding of team dynamics. Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon. With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products. With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation. Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs. We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Carrying out dispensing activities as per applicable procedure. Responsible for recording the observation of reaction parameters on the batch card as per approve procedure. Filling of all the batch card ( production cleaning) as per approved instruction Ensure verification of pH meters and weigh balances as per applicable procedures. Maintain work procedure, safety precaution and cGMP. Ensure housekeeping of plant and cleanliness of the equipment, update the equipment. Report accident and irregularities at the work station to the Shift Officer. To prepare the production batch card, protocol and other relative document of production ERP operation related to Production activities. Carrying out batch processing including raw material charging, unloading of material and sampling activities during intermediate production. Coordinating with QA for Online compliance of GMP at shop floor. All other Production related activities advised by the Superiors from time to time.

24 7 audit readiness Exposure in Wet Chemistry & responsible to works in different shifts Perform the raw material analysis & wet lab activity by using the technique (KF, pH, KFC, UV, FTIR, SOR, Oven, Auto titrator, Polari meter & TLC) etc. Sampling of Raw material / FG / intermediates / cleaning samples based on requirement and result entry in analytical sheet, QA form, LIMS and online documentation as per data integrity norms Perform analytical test according to the monograph and SOP & follow up the housekeeping, cGMP, GLP and Safety Guideline in laboratory Participation in internal, external, regulatory audits & Ensure 100% participation in training s against CAPA s Responsible for initiation and investigation on LIR, OOS, OOT & boarder line results and reporting them to the in-charge Responsible for calibration and verification of instruments & maintaining of reserved samples room and chambers Must be ensured sampled, approved, and rejected labels timely as required & responsible to maintain the stock record of chemicals and reconciliation of standards Determining team priorities in accordance with the plant s needs, while coordinating with the team leader/Manager.

Carrying out dispensing activities as per applicable procedure. Carrying out process and sampling activities during the production of Intermediate /API s according to approved batch cards. Responsible for recording the observations of reaction parameters on the batch card as per approved procedure. Filling of all the batch cards (production cleaning) as per approved instructions. Ensure verification of pH meters and weigh balances as per applicable procedures. Maintain work procedure, safety precaution and cGMP. Ensure housekeeping of plant and cleanliness of the equipments , update the equipment Report accidents and irregularities at the work station to the Shift Officer. Extensive equipment knowledge to perform trouble shooting and root cause analysis. Develops solutions to complex problems requiring resourcefulness and creativity/innovation and ensures solutions are consistent with organization s objectives. Work is performed without appreciable direction while exercising considerable latitude in determining objectives and approaches to assignment Good organizational skills, basic first-line management skills for daily operation, situational Leadership and decision-making skills Contributes to the development of new concepts, techniques, and standards including expert knowledge of cGMP standards . Coordination of production tasks to meet assigned schedule Knowledge of Liquide chromatography Operations.

Roles and Responsibilities: Production Scheduling, Coordination with Departments, Capacity Planning, Risk Assessment, Inventory Control, Lead Time Management, Adherence to Standards, Documentation, Collaboration with Sales team, Cost Control.

Role & responsibilities : Assist in the preparation, review, and submission of regulatory documents Help maintain regulatory files and records Support in compiling dossiers for product registrations and renewals Research regulatory requirements and updates from national/international authorities Coordinate with cross-functional teams for required data or documents Share your resume to hrd@stedmanpharma.com / 9786920463 Preferred candidate profile : This internship is ideal for students or recent graduates looking to gain hands-on experience in the field of Regulatory Affairs within the pharmaceutical industry. The intern will work closely with the RA team and assist with documentation, compliance tasks, and regulatory submissions.

Hii, Greetings from Avaniconsulting ! We are hiring for Production associate for a leading Pharma API Manufacturing company Position- Associate Work Experience Min 3-10 yrs in API Location - Mysore Gender - Any Qualification- B.Tech in Chemical Engineering /Msc Chemistry/Diploma Chemical/BSC Chemistry Roles & Responsibility 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 share their updated resume with below details to priyanka@avaniconsulting.com or whatsapp to 9518220852 1. Current CTC: 2. Expected CTC: 3 . Notice Period: 4. Total Experience 5. Current Location: 6. Preferred Location: 7. Reason for change:

Maintain QMS & ensure compliance with GMP standards across the plant Conduct audits, compile reports, approve vendors for RM & packaging Review documentation like SOP, BMR, BPR, APQR, etc Handle deviations, complaints, OOS reviews, and implement CAPA Required Candidate profile Experience facing audits in the pharma intermediates/API/bulk drug industry only; formulation experience not relevant Excellent communication skills for audits. Fluency in English & MS Office.

Role & responsibilities 1. Shall responsible to review implementation & maintain of the Quality Management system with the regulations. 2. Determining, negotiating, and agreeing on in-house quality procedures, standards and specifications 3. Checking & Maintaining of Master Documents related to the QMS system. 4. Shall responsible to review filled Batch Production control record & analysis report for batch release. 5. Responsible for coordinate validation activity and validation protocols. 6. Responsible for control and approve deviations whenever raised in the concerned department and record the deviations. 7. Review and approval of the standard operating procedures for other concerned departments. 8. Responsible to plan and carry out internal audits & MRM. 9. Responsible for Coordinate with QC/Production for handling and investigation of Market complaints. 10. Responsible for conducting on-going training programs for new recruits and retraining for existing employees of concern department on the topic of SOP, GTP, GLP cGMP, WHO, ISO, etc. whenever required or as per schedule & Responsible for verifying the effectiveness of training programs system. 11. To check and approve artworks in coordination. 12. Verification and approval of the change control whenever the change in the document, facility, process, and equipment. 13. Verification and approval of documents concern to the production process, analysis including quality system. 14. Responsible for verifying the effectiveness of corrective action and preventive action systems. 15. Responsible to review & maintain system represent in QA department SOPs like OOS, OOT, (document record, storage & retention), Document control, APQR, Calibration, Trend data, etc. 16. Should have better co-ordination with QA, Production, QC, Engineering & Maintenance, for implementation of cGMP and also the electrical department. 17. Responsible for complying with all regulatory queries during any inspection and audit. 18. Responsible for application to FDA, FSSAI, Kosher, Halal, ISO, and others for any approval like Technical person, License/Renewal License, and additional Product, GMP. 19. Also responsible to work on time and to ensure TAT (Turn Around Time) given by Directors, any other job assigned by Superior. 20. Ensuring the manufacturing processes comply with standards at both the national and international levels. Job Type: Full-time

Position- Manager - Sourcing (Pharma) Key Responsibilities: Sourcing & Procurement: Lead the procurement of Raw Materials, excipients and APIs from China, India and Europe, ensuring availability and regulatory compliance. Develop and implement strategic sourcing plans to optimize costs, quality, and supplier performance. Supplier Relationship Management: Establish strong relationships with suppliers, ensuring timely deliveries and addressing supply disruptions. Conduct supplier audits and manage quality agreements. Mangement of confidential, commercial, exclusivity and representation agreements. Regulatory Compliance: Ensure sourcing practices align with cGMP, ICH, and relevant FDA/EMA guidelines. Maintain proper documentation, including certificates of analysis (COA) and supplier qualifications. Market Research & Cost Optimization: Monitor market trends for pricing, supply chain risks, and new suppliers. Implement cost-saving initiatives while maintaining regulatory compliance and quality standards. Cross-Functional Collaboration: Work closely with R&D, Manufacturing, Quality, Logistics and Regulatory teams to meet material needs for new products and existing production. Team Leadership & Development: Lead and mentor a team of sourcing professionals, ensuring high performance and professional development. Preferred candidate profile Bachelors/Masters in Pharmaceutical Studies and Preferably a degree in Business Administration. Experience of approx. 7-10 years in sourcing with exposure to vendor Development in the Pharmaceutical Raw-Material Industry. Company Name: Molkem Chemicals Pvt. Ltd., India Company Website: https://www.molkem.com/ LinkedIn: https://www.linkedin.com/company/molkem/ Overview: Molkem specializes in delivering high-quality ingredients and formulations for the Pharmaceutical, Food, Nutraceutical, and Cosmetic industries. Further, we proudly carry forward our legacy in specialty chemicals, dyes, and pigments, meeting the diverse needs of industries including Textile, Leather, Polymer, Paint, Ink, and Plastics. Our continued commitment to these sectors ensures consistent quality and innovation for our valued partners With headquarters in India, Molkem has established a significant global presence, operating three distribution centers located in India, Dubai, and Brazil. This network is further enhanced by our subsidiaries in Brazil, Vietnam, and Dubai, as well as sales offices in Argentina and Colombia. Our upcoming state-of-the-art R&D and analytical development center - Molkem Labs in Ahmedabad, India, is set to offer R&D, Tech Transfer and CDMO services for oral solids, parentals, and novel drug delivery systems.

Retrival& Issuance of documentation GDP CGMP Control Documents Dispatch verification Batch Manufacturing

Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • You will be responsible for coordinating with cross functional teams for ensuring that preventive maintenance is carried out as per schedules in SAP. • Your role involves preparing the PMP (Preventive Maintenance Plan) and maintaining the necessary records of breakdowns and maintenance activities in the PMP as per defined frequency. • Your responsibilities include handling of external contractors and agencies, reviewing and ensuring implementation of the instructions (Work Instructions and SOPs – Standard Operating Procedures) related to production operation. • You will train and assist the team members during troubleshoot and breakdown of machines and commissioning of new Equipment. • You will ensure balance investigation and inventory control for all instrument spares parts. • Your role involves planning, consolidating and submitting the maintenance budget for the allotted area/unit. • You will ensure that the maintenance expense is within the budgeted amount. • You will be responsible for ensuring availability of all process equipment and regular maintenance of all process equipment spares by following up with OEMs (Original Equipment Manufacturers), external vendors and SCM (Supply Chain Management). • You will be accountable for enduring closure and completion all assigned CAPA (Corrective and Preventive Actions) on time. • You will be expected to support any technical/documentation activities at site as per instructions from Section Head. • You will be responsible for preparing, updating, and maintaining all necessary documents for audits like SOPs, formats, PM (Preventive Maintenance) books, protocols, and Machine History Books for the respective areas. • Your responsibilities include facility upkeep of respective areas as per GMP (Good Manufacturing Practices) and cGMP (Current GMP). • You will be accountable for ensuring implementation of Good Engineering Practices (GEP) at Site. Qualification Edu : Diploma in Electrical & Instrumentation Engineering or B. Tech in Electrical & Instrumentation Engineering. Responsible for coordinating and executing project development and handover activities of in-house projects in the plant In house Project Works and coordination with vendors during projects execution. Following all related SOPs, PMPs & OI's and ensuring concurrent Documentation. Maintenance & Machining of parts as per requirement. Closing of Change Controls, Job proposals, Quality, Non-Quality Impacting reports and cross checks Guiding and controlling external vendors working inside plant and arranging required material as per technical details required for work completion. Preparation of Engineering Provisions and drawings/layouts. Preparation of commissioning reports for new equipment, Instrument and submissions to Asset Team. Coordinating with CFTs for timely project execution. Training the user department and ensuring regular operation of systems implemented. Coordination with service providers during installations, commissioning and execution of qualification activities, breakdowns of systems & equipment. Technical evaluation of changes in the validated systems or processes. Responsible for addressing the deviations in external/internal audit observation in engineering processes, practices followed. Execution, Review, Installation & Commissioning of new equipment along with related documentation like DQ, IQ, OQ, PQ and related SOPs. Responsible for initiation, review of deviation management through incidents relevant to the in-house projects and incident investigation related to engineering. To Review of SOP's and OI's, coordination with QA and follow relevant SOPs. To follow the quality procedures and regulatory requirements. Monitoring of maintenance systems in SAP Responsible for planning of preventive maintenance Operation and Maintenance of pure steam generators. Responsible for taking the Periodic GXP Computerized system backup and submitting to IT department. Technical support to carry out the GxP assessment & controls for manufacturing machines. Good knowledge on PLC Programming. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

JOB DESCRIPTION Job Title: Costing & Sourcing Specialist Job Location: Bengaluru About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and respective teams. Contributing to development of procedures, practices and systems that ensure safe operations and compliance to the company s integrity & quality standards. Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace always. Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always in the workplace. Ensure all assigned mandatory training related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards always. Core Purpose of the Role: Costing and sourcing specialist for Large Molecule. Must have experience in procurement, RFX, Costing of Biologics raw material, consumables & Media/Resin on a commercial scale, AVD-Alternate Vendor Development. Role Accountabilities Develop and execute procurement category management strategies for Biologics operating unit which includes material of all categories (Raw Material, Media/ Resin, Single use consumables, etc.) in compliance to Current Good Manufacturing Practices (cGMP). Knowledge of RFP costing. Managing all F&B operations within the Area of responsibility assigned. Expert in developing AVD in compliance with CGMP practises, fair understanding of manage and create costing of materials (BOM-Bill of Materials). Manage the Supplier life cycle including supplier selection, assessment, development, and supplier consolidation to ensure optimization and better performance of Suppliers. Responsible for negotiations of best possible cost, service guarantee and develop win-win strategies that achieve sustainable relationships with suppliers and savings to be reported as per blue book of savings. Collaborate with the technical team, supplier for developing innovative products at optimized cost and delivery. Regular meetings, interaction, and communication with operating units to bring in operational excellence, faster delivery and overall efficiency in the strategic procurement business partnering Managing internal and external customers with regular MIS, communication, and meetings. Develop strong relationships with all the stakeholders, manage analytics, prepare reports for decision making. 100% accountable for meeting Customer QUOTIFs and ensuring timely delivery of all materials of the right quality. To execute the MSA of key spend suppliers and ARC of repeat purchases. Defining supplier management strategy, aligning it with overall Goal, and executing strategic supplier relationship management with key suppliers. Implement the supply chain strategies by development of Global suppliers including India. Identifying supplier risk areas and quantifying risk exposure and executing risk mitigation actions. Identify, develop and Qualify 2nd source from India of all key raw materials, preferably for repeat campaigns as part of business continuity plan (BCP). Undertake performance evaluation of vendors to improve product, cost, Quality and delivery performance. Shall ensure compliance with the QMS events owned/initiated in EDMS/track-wise. Thorough understanding of all SOP s and shall adhere to written instructions. Identification and evaluation of the vendors who comply GMP requirements, in consultation with Process Research and Development (PRD) and production department. Co-ordination with shortlisted vendors for vendor qualification/re-qualification as per Vendor Qualification SOP(s). Follow approved vendor list (AVL) for the procurement and subcontract activities. Responsible for audit conduct and clearance in alignment to GMP requirements. Syngene Values All employees will consistently demonstrate alignment with our core values. Excellence Integrity Professionalism Specific requirements for this role : Experience- 8 - 10 Year Education- MBA/M.SC

Greetings for day. We are having opening for the role Manager - QMS & Documentation Management in Corporate Quality Department. Department : Corporate Quality Location : Mumbai - Andheri East Qualification - B. Pharm. / M. Pharm / M. Sc. Industry Preferred : Pharmaceutical. Work Experience :12 - 18 years Corporate Experience only. Job Description : Quality Management System (QMS) Oversight: Ensure robust implementation and periodic / Retrospective review of all QMS elements including Change Control, Deviation, CAPA, Risk Management, and Quality Review. Documentation Lifecycle Management: Coordinate periodic SOP revision cycles. Ensure alignment with current practices, regulations, and audit feedback. Maintain SOP revision matrix and history. Electronic QMS/LMS Integration & Control: Develop and deliver orientation programs for new joiners covering company policies, ethics, compliance, and site-specific SOPs. Skill Requirements : Competent in extracting, organizing, and interpreting data from QMS systems for management review and trend analysis. Experience in preparing Quality Metrics, Dashboard Reports, SOP compliance trends, and identifying areas for process improvement Proficient in managing the document lifecycle, Organized approach to multi-department coordination, documentation deadlines, and QMS project execution. GMP Knowledge & Facilitation Skills: Deep understanding of cGMP/GxP concepts and strong delivery of technical training sessions . Interested candidate can share their profiles on pooja.t@encubeethicals.com

Role Summary: We are seeking a highly competent and detail-oriented Manufacturing QA Personnel with substantial experience in Sterile Injectable manufacturing , specifically focusing on Small Volume Parenterals (SVP) including Dry Powder, Liquid, and Lyophilized Injections . The selected candidate will ensure shop floor compliance and enforce GMP practices to maintain a state of readiness for inspections and regulatory compliance. Role & responsibilities : Ensure cGMP compliance on the shop floor during all stages of sterile manufacturing (formulation, filtration, filling, lyophilization, sealing, and visual inspection). Conduct and supervise line clearance, in-process checks, and aseptic practices adherence. Monitor and record activities for Dry Powder, Liquid, and Lyophilized Injectable production lines. Perform real-time batch record review and initiate necessary corrections. Ensure cleanroom behavior compliance , including gowning validation, personnel movement monitoring, and hygiene compliance. Coordinate with Production, QC, and Engineering for investigation of deviations, change controls, and CAPAs related to the manufacturing process. Participate in the qualification/validation activities including media fills, equipment qualification, and cleaning validation . Review SOPs, protocols, and BMRs for compliance with regulatory standards and internal policies. Provide training and on-floor guidance to production teams regarding QA best practices and compliance expectations. Ensure readiness for audits and inspections by maintaining appropriate documentation and control practices. Collaborate with cross-functional teams for continuous improvement and risk mitigation in manufacturing QA processes. Required Skills and Competencies: Strong understanding of sterile injectable manufacturing processes and controls, especially for SVP, Dry Powder, and Lyophilized dosage forms. Hands-on knowledge of cleanroom classifications, aseptic techniques, environmental monitoring , and equipment sterilization/cleaning . In-depth knowledge of cGMP, WHO, EU GMP, and PICS regulations . Experience handling deviations, OOS, CAPA, change controls, and batch record reviews . Ability to work in cross-functional teams and provide real-time QA support to operations. Proficiency in documentation practices and QA audits/inspections . Good communication, observation, and leadership skills.