137 Cgmp Jobs - Page 4

Designation: Quality Assurance Chemist Location :Medchal, Hyderabad Qualification: B.sc/B.pharma Experience: Min.3 relevant exp as Qa chemist Package: 4-5LPA Shifts: General shifts If interested Contact: 8247381453 Share Cv laxmi@hireiton.com Required Candidate profile • Qualification of utilities like Purified Water systems • Reviewing BMR/BPR & issuing analytical worksheets, logbooks • Must have worked in a pharmaceutical company in the past

JOB DESCRIPTION 1) ARD Scientist (Analytical Research & Development Scientist) Positions Sr Scientist -1 Junior Scientist-2 Job Description: ARD Sr Scientist/Jr Scientist capable in developing and validating analytical methods and Validation including calibration to ensure the quality and stability of pharmaceutical products. Key Responsibilities: Develop and validate analytical methods for drug substances and drug products. Perform analytical testing such as HPLC, GC, and wet analysis. Interpret analytical data to assess product quality, purity, and stability. Implement GLP & GDP practices. Prepare technical reports and documentation for regulatory submissions. Collaborate with the FRD & DQA to support product development. Troubleshoot analytical method issues and recommend improvements. Qualifications: Masters degree or Ph.D. in instrumental analysis, Analytical Chemistry, or related discipline. Expertise in analytical techniques such as HPLC, GC, and spectroscopy. Strong knowledge of regulatory guidelines such as ICH and FDA. Good documentation and report-writing skills. Problem-solving and analytical thinking abilities. Minimum 3(or) More Years for Junior scientist of experience in ARD /Q.C . For Sr Scientist 8 (or) more years of experience is desired 2) FRD Scientist (Formulation Research & Development Scientist) Positions Sr Scientist -1 Junior Scientist-2 Job Description: FRD Sr Scientist/Jr Scientist is responsible for the research and development of pharmaceutical formulations, ensuring the products are safe, stable, and effective for consumption. Key Responsibilities: Design, develop, and optimize formulations for pharmaceutical or nutraceuticals Etc. Implementation of QbD . Conduct experiments to test product stability, and efficacy. Prepare technical documents, including formulation protocols and reports. Collaborate with cross-functional teams such ARD, DQA Etc to ensure compliance. Troubleshoot formulation issues and propose solutions. Qualifications: Masters degree in pharmaceutics or Ph.D. in Pharmaceutics & Equivalence, Minimum 3(or) More Years for Junior scientist of experience in FRD /R&D . For Sr Scientist 8 (or) more years of experience is desired Strong understanding of Good Manufacturing Practices (cGMP). Problem-solving skills and GDP implementation Skills in usage of software for developing of formulation and characterization. Excellent communication skills to present findings and collaborate with teams. Exposure in developing Liquid Orals, Solid Orals, Semi-Solid Orals. Nano formulations will be preferred 3) DQA Team (Development Quality Assurance Sr. Executive) Positions Sr Executive -1 Jr Executive -1 job Description: DQA Sr. Executive should monitor the quality assurance processes during product development, ensuring that all stages comply with quality standards and regulatory requirements and product specification need as per ICH Guidelines. Key Responsibilities: Lead quality assurance activities for product development, including design, testing, and validation stages. Ensure compliance with regulatory guidelines and quality standards (e.g., FDA, EMA, GMP). Develop and implement quality control procedures for new product development. Conduct internal audits and prepare quality assurance reports. Collaborate with R&D, ARD to implement the quality issues. Manage risk assessment processes and ensure continuous improvement in quality systems. Should have knowledge in QbD system for product development. Qualifications: Minimum experience should be 6-8 Years for sr executive and 1 to 3 years for junior executive in DQA (or) Q.A Bachelors or Masters degree in Quality Assurance /Analysis/Pharmaceutics, In-depth knowledge of cGMP, GDP, GLP, ICH and regulatory requirements and implementation. Excellent communication and problem-solving skills.

Expertise in computer system validation, QMS and IT Compliance. Good understanding of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9. Validation experience and expertise in manufacturing, QC, Investigation, CAPA, Deviati

As an AGM Production in a pharma formulations company, you'll be responsible for : leading and optimizing the production process (planning and execution) ensuring adherence to GMP standards, managing resources, and achieving production targets while maintaining quality and cost effectiveness Responsible for: Technical Operation, Production, planning, vendor development with follow up, costing, projects management, quality, installation and expansion of operations Achievement of Production planning and accountable to ensure optimal utilization of all resources including manpower, machinery and raw materials Identifying potential bottlenecks and deviations, implementation corrective action to ensure that production targets are met within stipulated time and budget constraints Follow up with various departments for control to ensure smooth operation at the production lines /leading different plant audits Analyzing daily reports to plan further production keeping keen eye on deadlines as well as ensure order delivery as per agreed plan with keen eye on Quality. Implementation of inventory control measures to reduce obsolete stock. facilitating value engineering initiatives at the suppliers end to reduce cost of rejection of suppliers and in process production material. Performing analysis, root cause analysis, best practices for productivity improvement in production, repetitive problems (rework -rejection), Cost reduction and process updating. Preparing strong and reliable MIS reports to Streamline material management, Cost saving, Vendor quality assurance operations for facilitating the decision-making process in liaison with Management Able to handle the production as a Leader and must be good at people management at plant Preferred candidate profile B. Pharma/M, Pharma with minimum 15 years of core experience in production (tablets and capsules- allopathic & nutraceuticals), minimum 5 years at a leadership level at plant Leadership with people management with strong technical expertise Proven ability to work efficiently in both independent and team environments Must be a dynamic and positive as a leader

Production Chemist OSD and Ointment Section Location: Ahmedabad, Gujarat, India Department: Production Job Summary: The Production Chemist will be responsible for overseeing the production processes for oral solid dosage (OSD) and ointment formulations. This includes ensuring adherence to GMP standards, optimizing production efficiency, and maintaining the highest quality of pharmaceutical products. The role involves direct supervision of manufacturing activities, adherence to quality protocols, and collaboration with cross-functional teams to ensure seamless operations. Key Responsibilities: Supervise the manufacturing activities in the OSD and ointment sections, ensuring processes are carried out as per standard operating procedures (SOPs). Ensure compliance with WHO-cGMP, USFDA, and other regulatory standards at all stages of production. Monitor production processes to meet predefined quality, safety, and efficiency goals. Prepare, review, and maintain batch manufacturing records, logbooks, and other production-related documentation. Collaborate with the QA and QC teams to promptly address and resolve quality issues. Train and mentor junior staff and operators on production protocols, equipment handling, and GMP standards. Conduct troubleshooting and maintenance of production equipment and processes to minimize downtime. Assist in the validation of new equipment, processes, and cleaning procedures. Qualifications: Bachelors or Master’s degree in Pharmacy (B.Pharm/M.Pharm). 3-5 years of relevant experience in OSD and ointment production. Strong knowledge of GMP and regulatory guidelines. Proficiency in production planning and execution. Excellent organizational and problem-solving skills. Effective communication and leadership abilities.

Job Summary: The Microbiologist will be responsible for ensuring microbiological quality assurance and compliance in pharmaceutical manufacturing processes. The role includes conducting microbiological testing, validation, and ensuring compliance with WHO-cGMP and other global regulatory standards. Location: Ahmedabad (Kalol)- Local candidates preferred Key Responsibilities: Perform microbiological testing of raw materials, finished products, and water. Conduct sterility, bioburden, and endotoxin testing. Oversee environmental monitoring of cleanrooms. Validate microbiological methods and equipment. Prepare and review microbiological reports and documentation. Implement and maintain microbiological controls in line with regulatory standards (USFDA/EU/PIC/S). Investigate microbiological deviations and provide corrective actions. Qualifications & Skills: Bachelors/Masters in Microbiology or related field. 4-6 years of experience in pharmaceutical microbiology. Strong knowledge of WHO-cGMP standards and regulatory guidelines. Excellent analytical and problem-solving skills.

Supervision of production in shifts Shop floor management Reaction handling Manpower management Plant operations Process monitoring Documentation Production record maintenance Product labelling, packing activities Ensuring GMP in production process Required Candidate profile B Sc. (Chemistry) or Diploma (Chemical) with minimum 2 years experience in production supervision in shifts Experience in API production preferred Need to work in shift Manpower management experience Perks and benefits Commensurate with experience and knowledge

Position Overview: We are seeking a knowledgeable and results-driven CSV Engineer to join our team, specializing in providing expert validation services to our clients. In this role, you will work closely with a diverse range of companies, ensuring the compliance, reliability, and quality of their computerized systems while adhering to industry regulations and best practices. Key Responsibilities: Validation Strategy and Planning: - Collaborate with clients to develop tailored validation strategies and plans based on their specific needs and regulatory requirements. - Assess project scope, goals, and timelines to design efficient validation approaches. Validation Execution: - Design, develop, and execute validation protocols, including IQ, OQ and PQ to verify system functionality and compliance. - Provide on-site or remote assistance during testing and data collection phases. Documentation and Reporting: - Generate comprehensive validation documentation, such as validation master plans, Risk assessment/GxP Assessment, FS, CS, FRA, test scripts, 21 CFR PART 11 Assessment and validation reports. - Create clear and organized documentation that demonstrates compliance and traceability. Change Control and Risk Management: - Collaborate with clients to assess and manage risks associated with changes to computerized systems, ensuring proper change control procedures are followed. - Advise on the impact of changes and recommend appropriate validation strategies. Regulatory Compliance: - Stay up-to-date with relevant regulations, guidelines (e.g.,21 CFR PART 11, EU Annexure 11, cGMP, GAMP5, Data Integrity etc.), and industry trends related to computer system validation. - Apply your expertise to guide clients in meeting regulatory requirements during the validation process. Client Collaboration: - Build strong working relationships with clients, acting as a trusted advisor and validation expert. - Provide guidance, recommendations, and regular updates to ensure successful validation outcomes. Training and Support: - Provide training to Perfect Utilities engineers involved in the validation process, empowering them to understand and implement validation principles. Continuous Improvement: - Offer insights and suggestions for process improvement and optimization within the validation lifecycle. Required Qualifications and Candidate Profile: Diploma, Bachelors Degree or equivalent in technical area preferred 1-5 years of hands-on experience in computer system validation of PLC based complex system preferably across different industries and systems. Knowledge of BMS, DCS, Lab Software Validation, Vision Software Validation. Being familiar with validation principles, regulatory requirements (e.g., 21 CFR PART 11, EU Annexure 11, cGMP, GAMP5, Data Integrity etc.) Proven track record of delivering successful validation projects and ensuring compliance. Excellent communication and interpersonal skills to collaborate effectively with diverse clients. Candidate should be ready for travelling across India. Benefits: As a valued member of our team, you will enjoy the opportunity to work with a range of clients, contribute to their success, and expand your professional network. We offer competitive compensation, a dynamic and supportive work environment, and the chance to make a meaningful impact in the industry by delivering exceptional validation services. If you are a skilled CSV Engineer with a passion for assisting companies in achieving compliance and reliability in their computerized systems, we invite you to join us. Help us provide top-notch validation expertise and contribute to our clients' growth and success.

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation DQA- Department . Position :Executive or Sr Executive Experience : 2 -8 Yrs Job Description: 1) Handling of QMS documents like Incident, change control and LER. . 2) Review of Formulation Analytical Development & Method Validation and Transfer Protocols and Reports. 3) Review of Product development with QbD approach. 4) Review of FRD Documents (LNBs, BDRs, PDRs, MFRs and MPR) 5) Preparation and Review and Approval of SOPs ,Guidelines. Responsible for conducting Internal Audits/External Audits for Cross functional Departments.Responsible for Review and Approval of Vendor Qualification Please Share me Update Resume :Careers@biophore.com Total Exp: Current CTC: Exp CTC: Notice Period: Designation:

A Clean Shaven Personnel having a experience of Not Less than 2 and NMT 3 Years in Sterile Facility -Experience of having worked in the Sterile Area -Execution of AHU, Autoclave and DHS Validation -Temperature Monitoring Execution -Review of BMR/BPR before final Submission -Knowledge of Dry Powder, Ampoule Section and the Asceptic Practices

QC officer Perform chromatographic analyses and tests, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Thin-Layer Chromatography (TLC), on raw materials, in-process materials, and finished products. Required Candidate profile Urgent looking for Male candidate who is able to work in rotation shift.

Responsibilities: Conduct FG (Finished Goods) Inspection in the warehouse and promptly communicate relevant observations to the concerned vendor. Ensure timely dispatch of FG samples for testing and review the testing reports upon receipt. Prepare monthly reports summarizing findings from FG inspections. Efficiently handle market complaints, ensuring closure within stipulated timelines. Demonstrate a comprehensive understanding of current cGMP and FSSAI norms. Possess knowledge of In-Process Quality Assurance (IPQA) procedures. Willingness and readiness to travel as required. Qualifications: Bachelor's degree in a relevant field. Proven experience in quality control within the manufacturing or related industry. Familiarity with cGMP, FSSAI norms, and IPQA. Strong attention to detail and analytical skills. Excellent communication and interpersonal abilities. Ability to meet deadlines and work effectively in a team.

Background Industry: Medical Devices (EU Class 2b or higher) manufacturing company with turnover higher than 300 Cr Required Skills: Experience in QA management across multiple projects involving the implementation of the Company's QA processes and strategies. The projects include IPQA, QMS, validation and Compliance related assignments Ensure that the norms and laws, set by regulatory authorities, are met. Preferentially an audit experience for EU MDR, PMDA, SFDA, TGA and KFDA requirements Excellent knowledge of QA processes including of risk management, clinical data management and electronic data management systems. Ability to handle adverse events and rectify non conformities reported in inspections

-Conduct quality control tests on raw materials, intermediates, and finished products to ensure compliance with FDA regulations. -Must have experience of Approval of tablets and capsule -Overseeing and executing the active pharmaceutical ingredients Required Candidate profile Approval of Tablets and Capsules is Must Male candidate prefered Changodar Location

Purpose of the role: Responsible for all areas of the Engineering function of DS block and Water System. Primary Responsibility: Strategic: • To conduct Periodical plant energy audits to improve the efficiency of the system & to bring down the operating cost. • Plant upgradation works planning, execution on periodical basis. • Plan & work towards the target set by the management based on business needs. • Updated & aware of cGMP requirements. Operational: • Operation & Maintenance of Utility equipment’s – Boiler, Chiller, Hot water system, Cooling tower, Air compressor, Pumps, Valves, Piping system. • Operation & maintenance of clean Utility equipment’s: Raw water storage & Distribution system, Water Pre- Treatment system, Softener, Purified water generation, Water for Injection generation, Pure steam generation along with Storage & Distribution system. • Attend to Preventive & Breakdown maintenance for Plant & Process equipment’s related to Drug product- Filling lines, Autoclaves, Manufacturing/ Filtration vessels, CIP, SIP, TCU, Autoclaves, Packing machine, etc. Drug Substance- Fermenters, Centrifuges, Homogenizers, HPLC columns, Filtration vessels, CIP, SIP, TCU, Autoclaves, etc. • Gas distribution systems. • Mechanical maintenance support Fire protection systems. • Mechanical support for ETP & STP. • HVAC, BMS, EMS systems. • Good Documentation practices. • Monitoring of outsource agency for plant operation. Review & coordinate for finalization of agreements. • Preparation/Review/Training of SOP, Preventive Maintenance, Break down Maintenance, Schedule, Planning. • Knowledge of plant safety & cGMP requirements. Audit & Statutory Compliance. • Coordination with user departments & plan for Preventive/Breakdown maintenance. • Ensure smooth operation of plant & machinery to avoid breakdowns & production loss. • Plan for required spare parts inventory & AMC. • Shift scheduling, Manpower planning & reporting. • Computer skills including Auto CAD, Microsoft Projects. • Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ. • Goal settings to team members & annual review. Providing the same to department head for review & approval. • Responsible for handling of controlled documents such as SOP’s, logbook and qualification protocol etc., • Responsible to ensure preventive maintenance of the equipment is completed as per schedule and review the preventive maintenance schedule as per SOP. • Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ including EDMS documentation

QC Chemist Executive Min 2-3 Experience Salary: 15K-25K Location: Vadodara Gujrat

Quality Control Dept, ensuring Timely testing & quality check of Raw Materials and Finished Products. Analysis on equipment like HPLC, FTIR, GC etc, all other Q.C. related matters Required Candidate profile Experience in handling HPLC, FTIR, GC etc, for 3 to 7 yrs, Experience in Quality Control dept. of Pharma Company. FDA Approval Required. Perks and benefits Apply with Salary Drawn & Expected Salary

1.Responsible for batch record issuance. 2 Responsible for issuance of change control 3.Resposible for implementation of ISO & Quality Management System 4. Responsible for calibration & validation of Equipements & Instruments 5. Responsible for inprocess Quality Checks 6.Resposible to implement CGMP 7. Responsible to monitor product activity 8. Responsible for issuance & retrival of control document 9. Resposible for dispatch verification 10. resposible to prepare process validation proyocal & record

1. To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical Report for raw material, finish product and packing material. 2. Assistance in preparation of SOP of various departments/ preparation of draft SOPs. Required Candidate profile To review manufacturing, store, QC activity. To prepare approved vendor list and maintain vendor qualification. To Attend QR meeting as per schedule Call/ Whatsapp : 91-9327657730 / 9724346949

Qualification: Regular M.Sc. (1st class is mandatory) - 60% Throughout in All Streams Work Experience: 6– 12 Years (In the field of QA in Pharma/Chemicals/Agrochemicals)

• Responsible for Defining and Implementation of Quality Management system and Quality Assurance processes across OSD and CMO/ CRO locations. • Ensuring compliance with all cGMP requirements in line with global and Indian regulatory requirements • Handling all Regulatory audits, Client Audits, Internal Audits • Responsible for Qualification /Audit of CxP Vendors and CxP service providers • Responsible for GxP Training • Responsible for providing all documentation and other necesary support for Regulatory for product registrations and life cycle management • Responsible for providing all documentation and other necessary support for Business / Marketing, Customers • Responsible for management of Deviations, OOS, Complaints, Changes, Qualifications, Validations • Responsible for Licenses, Certifications and compliance (Indian FDA / CDSCO)

This position is based at our Sun Pharma, Baska plant . We are looking for dynamic professionals from Pharmaceutical background, having 10+ years of experience in end-to-end supply chain planning activities. Position : Manager Supply Chain (PPIC) Department : Supply Chain Location : SPML Baska, Vadodara Sun Pharma Experience : 10-15 Years of Total Work Experience Preferable Skills : Good knowledge of SAP, APO, XLS, and good communication and presentation skill Education : B. Pharm/M. Pharma, BE/ME, Masters (MBA, MS) or equivalent degree in Supply Chain No. of Vacancies: 1 Job Role : The role will be responsible for end-to-end Supply planning activities at formulation plant Key Responsibilities: Ensure continuous improvement in key Metrics like DvsC and CvsS, Sufficiency, Back orders, Inventory optimization, Capacity utilization etc. Own monthly planning cycle. Take end-to-end responsibility of plant Supply planning including Production Planning, Commits, Improve DCS, run MRP, RM/PM availability and Inventory Control for sterile operations Baska formulation plant. Evaluate RFC (Rolling Forecast) every month with current and forward looking (along with new product launching across all market) in terms of value, volume, capacity & material availability etc. Based on which participate in production planning along with respective stake holders and confirming commitment against market demand to various businesses. Based on market priority, manufacturing and execution plan, pre-commits (M1 to M3 month) to be prepared and share with market. Post commit release ensure S&OPs / commit alignment calls with each market demand planning team & capture the suggested changes in final commit release MRP run and PR validation post MRP and transfer PR from APO to SAP. Master data management. Pre-MRP APO hygiene including recipe and missing master data update. Co-ordination with respective stake holders (Stores, QC, QA, Microbiology etc.) at plant for timely release of RM/ PM and FG and ensure maximum utilization of resources. Daily performance dialogue with respective stake holders for avoid delay / issue resolutions Co-ordination with procurement team for availability of optimum RM/ PM in time Inventory control for excess, non-moving & expired inventory. Ensure optimization of an inventory with NIL shortages against production plan and appropriate implementation of buffer norms. Proactive procurement initiation at time of need based on risk assessment. Review and timely cleaning of Non-Moving and expired inventory thru destruction, plant to plant transfer, Code to Code transfer or sale off with coordination with SLOB team /commercial team / ware house. Regular review, validate & updating of safety stock norms, MOQ, Lead time, GR time etc. for effective material planning & Inventory management. Coordinating for plant functional activities in plant and outside plant including commercial, Central Supply Chain, Demand Planning, Marketing, Regulatory, PDD, MSTG, R&D and ADD take place in coordinated and productive manner for achieving desired outcome. Preparation of DCS, S&OP, executive S&OP, Sufficiency review, monthly/ quarterly review data with right reasoning as per management requirement. Interface with different functions at various level of detail, with the ability to Draft presentations, summarize and highlight issues to Executive Level management Ensuring continual improvement, training, following cGMP as per various regulatory and patient safety requirement. Ensuring team development and attrition control. Apart from this any other tasks/responsibilities provided by management and/or reporting managers. Effective management of Change notification in RM / PM, Artwork changes with close co-ordination between corresponding stakeholders.

RESPONSIBILITIES Preparation and review of master batch records / batch manufacturing records, qualification documents (URS, DQ, IQ, OQ, PQ, volumetric calibration, surface area calculation etc.) & QMS documents. Preparation and review of standard operating procedure. Preparation and review of organogram, job responsibility, training needs & list of list. Preparation and review of training matrix & training plan. To ensure online documentation related to all CGMP activities including data integrity. Initiate, review & complete required change control, deviations, investigations & CAPA impact. Reviewing & maintaining all logbooks in the manufacturing area and plant. Operation of primary and secondary water treatment plant as per standard operating procedure and look after operations in solvent recovery plant. Responsible for performing validation & qualification activities in the plant (equipment qualification, process validation, cleaning validation). Responsible for the execution of validation & scale up batches for all the products to be manufactured. Proper utilization of available manpower (no contract people) & manufacturing facilities to enhance productivity. Ensuring timely manufacturing schedule as per production planning & maintaining quality & safety parameters. DESIRED SKILLS Must have experience in API production in reputed pharma organizations. Should have hands on experience of Manpower Handling Strong knowledge of operating DCS (Distributed Control System) One Should Manage Shift Planning Handling of Water System Operation Handling of Process Equipments like Reactor, Centrifuge, RCVD, RVPD, FBD, Bin Blender, Co-mill, etc Good Knowledge of preparing BMR and BPR. Should have sound knowledge of drafting and reviewing of SOP’s. Good Communication and problem solving skills. Should be assertive, proactive, and self-driven. Ability to work in dynamic environment.

Sr. Manager - Projects ( Injectable) Domnic Lewis has been mandated to hire forSr. Manager - Projects ( Injectable) We are seeking a highly skilled Senior Manager to lead and manage our Green Field, Brown Field, and Capacity Expansion projects for our Injectable pharmaceutical operations. This role requires expertise in handling projects from conceptual design through to commissioning, with a strong focus on ensuring compliance with cGMP and international regulatory standards. Key Responsibilities: Project Management: Independently manage and oversee Green Field, Brown Field, and Capacity Expansion projects from concept through to commissioning. Develop and prepare Capex budgets for Mechanical, Electrical, and Plumbing (MEP) services, including Black and Clean Utilities, HVAC systems, and associated cost estimations. Prepare detailed Bills of Quantities (BOQ) with technical specifications and create comprehensive project execution plans in collaboration with the Project Lead. Equipment Planning and Sizing: Plan and size equipment for injectable facilities, including Vial and Ampoule Filling Lines, Lyophilizers, Pre-Filled Syringe (PFS) Machines, Manufacturing Vessels, Autoclaves, Packing Equipment, and Cold Rooms. Oversee the utility equipment requirements including Boilers, Air Compressors, Chillers, Fire Hydrant Systems, and Effluent Treatment Plants (ETP) Sewage Treatment Plants (STP). Compliance and Documentation: Ensure adherence to cGMP audit requirements and compliance with EU, WHO, and MHRA documentation standards, including URS, DQ, IQ, OQ, and PQ. Project Coordination: Manage project planning, design coordination, and both front-end and detailed engineering activities. Facilitate technical and routine coordination with interdisciplinary engineering teams, consultants, OEMs, and suppliers to ensure project completion within budget and on schedule. Implement alternate strategies to resolve conflicts and monitor and control site operations for safety and quality. Technical Skills and Software Proficiency: Proficient in AutoCAD (Mid-Level User) and scheduling software such as MS Project. Experienced with SAP PS and MM modules. Knowledgeable in ISO 14001, ISO 45001, Six Sigma, Factory Act, MIDC Norms, PWD Norms, MPCB, and NBC Codes. Skills and Qualifications: Proven track record in managing complex pharmaceutical projects with a focus on injectables. Strong understanding of cGMP and international regulatory requirements. Excellent project management skills with the ability to coordinate and lead cross-functional teams. Proficiency in relevant software tools and technical standards.

- 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