302 Cgmp Jobs - Page 2

Division Department Sub Department 1 Job Purpose Execute the production operations in line with safety and GMP requirements to meet the manufacturing targets in shift, Key Accountabilities (1/6) Operate the equipment efficiently without error and deviation as per SOP to meet shift targets Perform unit operations as per SOP and unit processes as per batch manufacturing record Optimize the utilization of available resources for achieving production in shift Maintain equipment, facility and block premises as per SOP for audit readiness Key Accountabilities (2/6) Provide suggestions for optimization of processes to manufacture quality product Identify the deficiency in area and errors in documents and rectify them as per requirement Propose and implement new idea to enhance production, optimise the use of consumable goods and maximum utilization of resources Key Accountabilities (3/6) Execute and update online documentation to meet cGMP requirements Maintain online documentation and timely entries in BMR and supporting documents Check documentation before submission to ensure data integrity Key Accountabilities (4/6) Deliver training to workmen and adhere cGMP and safety guidelines in production process to ensure smooth operations Conduct training related to cGMP, equipment operation, safety and housekeeping for workmen Optimize the use of resources in housekeeping Ensure good housekeeping and sanitisation as per the guidelines Ensure usage and maintenance of PPEs by workmen during shifts Report any near-miss to officer in-charge in time Key Accountabilities (5/6) Key Accountabilities (6/6) Major Challenges Meeting shift targets due to unavailability of adequate resources Overcome by efficient work load distribution and resource optimisation Meeting production targets due to lapses in knowledge transfer between shifts Overcome by bridging gaps between inter-shift communication Key Interactions (1/2) Engineering & Utility for system and equipment related queries (Daily) Safety for safety rounds and PPE (Weekly) Formulation Technical Support for troubleshooting in products (Case Basis) Formulation Tech Transfer for support in new products (Project Basis) Key Interactions (2/2) Equipment manufacturer for troubleshooting in machine (Case Basis) Dimensions (1/2) Number of dosage forms : 2 Number of tech transfer supported per month : 2 Number of batches executed per month : 35-40 Achieve internal OTIF more than 90% Meet percentage utilisation of plant as per the plan 0% errors in documentation Zero reportable accidents / incidences during manufacturing Achieve 0% failures / deviations target 100% compliance to SOP Dimensions (2/2) Key Decisions (1/2) Scheduling house-keeping activities Key Decisions (2/2) Equipment Selection to Section Head Modification in plant and equipment to Production Officer Education Qualification Diploma in Pharmacy / Mechanical Relevant Work Experience 0-2 years of experience in a manufacturing organisation preferably in pharmaceutical industry Show

Division Department Sub Department 1 Job Purpose To execute the activities that are related to microbiology laboratory, Key Accountabilities (1/6) Involvement in all quality related activities Maintenance of all the area and the equipment, To ensure and monitor compliance with GLP and cGMP as per requirements of the respective authority, Key Accountabilities (2/6) Environment monitoring Monitoring of area to be carried out as per allocated schedule, Release and transfer within the timeframe mentioned in SOP, Follow the written procedure for Execution of aseptic process validation and testing of Aseptic process validation sample, Involvement in process Simulation, Key Accountabilities (3/6) III Media, PST management Stock of media and presterilized items to be maintained, Issuance to be done as per requirement Key Accountabilities (4/6) Water and MLT Water Analysis to be carried out as per schedule MLT to be carried out as per planning, Pathogen Continuation and releases should be on time Should ensure completeness of entries of all the tests performed and compilation of relevant data before submission for review, Disposal of balance samples after completion of analysis and review Key Accountabilities (5/6) Training To be present in any arranged scheduled training by the trainer, LMS training to be caried out before due date, Key Accountabilities (6/6) Major Challenges Releases of all the activities carried out should be on time, Maintenance of stock in the laboratory, Decontamination of material should be on time, Key Interactions (1/2) Internal Interaction with team members for all related activities including handover during shift changeover, Key Interactions (2/2) External Interaction with service engineers during AMC and laboratory visits, Interaction with external party during external calibration and validation of equipment, Dimensions (1/2) Should have basic knowledge of microbiology and relevantly qualified, Dimensions (2/2) Key Decisions (1/2) Decisions Suggestions and ideas for work simplification, Connecting with external Subject Matter Experts/ senior leaders within Cipla, Key Decisions (2/2) Education Qualification Educational Qualifications Post Graduate in Microbiology Relevant Work Experience Relevant experience: 2 5 years in pharma, microbiology, Good Knowledge about pharma process 2-5 years (Quality section) Good knowledge about computer (Excel, PPT and word file) Show

Role & responsibilities Knowledge of Operation & Maintenance of Instrumentation like HMI, PLC,SCADA in Pharmaceuticals (OSD) manufacturing facility and equipment upgradation. Basic knowledge on PLC (Programmable Logic Controller) and Computerized System (SCADA). Designing requirement in accordance with contract specification & desired performance. Ensure compliance to cGMP & Audit requirements. Leading a team of Electrical, Instrumentation & Software Engineers working in multiple projects. Note : Candidate who can Join Immediately are preferred and willingness to work in Shift basis. Candidate should have experience in Pharmaceutical Formulation - OSD - Tablets Manufacturing facility

As a Sr. Executive / Assistant Manager Quality Assurance (QA) at SAVA Healthcare Limited, Surendranagar Plant, your primary responsibility is to ensure the implementation and maintenance of cGMP practices, quality systems, and compliance with regulatory requirements. You will oversee QA activities including documentation, validations, audits, and shop floor compliance to uphold product quality and regulatory adherence. Your key responsibilities will include ensuring compliance with cGMP, SOPs, and regulatory requirements on the manufacturing floor, reviewing and approving batch manufacturing records (BMRs) and batch packing records (BPRs), handling deviations, change controls, CAPA, and quality risk management activities, conducting self-inspections, and supporting external/internal audits. You will review and approve SOPs, protocols, and reports related to validation, qualification, and quality systems, monitor and support validation activities, oversee document control, ensure timely closure of audit observations and CAPA implementation, and coordinate with various departments to ensure overall GMP compliance. Additionally, you will participate in training programs and provide QA training to cross-functional teams. SAVA Healthcare Limited (SHL) is a diversified pharmaceutical company committed to delivering quality-driven pharmaceutical solutions globally. Established in 2003, SHL has a strong presence in International Business, Animal Healthcare, Herbal Products, and Contract Research & Manufacturing Services (CRAMS). The ideal candidate for this role should have a B.Pharm / M.Pharm / M.Sc. degree with 4 to 7 years of experience in QA in a regulated pharmaceutical formulation plant. You should possess a strong understanding of GMP guidelines, quality systems, validation practices, and regulatory audits. If you are passionate about maintaining high-quality standards, ensuring regulatory compliance, and contributing to the success of a leading pharmaceutical company, we encourage you to apply for this exciting opportunity at SAVA Healthcare Limited, Surendranagar Plant, Gujarat.,

The role offers you the opportunity to complete product quality checks under close supervision. You will be responsible for conducting routine testing and analysis of production work, ensuring accuracy in quality checks and documenting quality control issues as needed. Your essential functions will include timely analysis of samples under test, coordinating with production for quality-related issues, sampling and analyzing RM/Intermediate/Finished Goods, ensuring compliance of ATR, assisting in ISO implementation, and possessing knowledge of calibration, standard preparation, standardization, and relevant documentation. Furthermore, you will need to have expertise in handling HPLC, GC, and wet analysis. As part of your department-specific and ongoing functions, you will be required to provide timely reports to SAP for result recording, fill and update all relevant documents, maintain zero accidents in quality operations, achieve batch-wise timelines, quantity, and quality, train and supervise operators in your department, participate in the Emergency response team, and maintain ISO 9001:2008 and ISO/IEC 17025:2005, SAP, and other Quality systems. To qualify for this position, you must hold an M. Sc. in Chemistry and have 3-4 years of experience in Quality, including cGMP, ISO, and regulatory audits, as well as laboratory safety. Preferred skills and qualifications include knowledge of Quality Control in Fine Chemicals and pharmaceutical companies and experience of cGMP. Desired skills and competencies for this role include willingness to learn, being a team player, and possessing good communication skills. Please note that the above statements are a general description of the nature of work performed in this classification and are not exhaustive. Avantor is an equal opportunity employer committed to diversity and inclusion. Join our global team of 14,000+ associates at Avantor and make a difference in people's lives through life-changing science. Dare to go further in your career, contribute your talents, learn new skills, and grow with us. Apply today and be part of a culture that supports your career growth and success. If you require a reasonable accommodation during the employment process, please contact us at recruiting@avantorsciences.com to discuss your needs. Requests for accommodation will be considered on a case-by-case basis. By submitting candidates without a formal assignment or contract from Avantor, you forfeit any fee, as per our 3rd Party Non-solicitation Policy. Avantor engages with recruitment agencies based on its needs and does not accept unsolicited solicitations.,

As a Section Head - API Production in the Manufacturing department, your main responsibility will be to control manufacturing activities within your section. Your goal is to ensure that all activities are performed in compliance with cGMP and safety standards to achieve quality and manufacturing targets within the specified time frame. Your key accountabilities will include monitoring and controlling planned production on a daily basis to meet targets and quality standards, overseeing maintenance activities to optimize the use of manufacturing consumables, preparing and updating GMP documents to ensure regulatory compliance and product quality, managing manpower availability across shifts for uninterrupted production, monitoring employee and workplace safety, and implementing initiatives for continuous improvement and manufacturing excellence. To qualify for this position, you must hold a B.E/B.Tech degree in Chemical Engineering and possess 10-12 years of experience in API Manufacturing. You should have a strong understanding of manufacturing procedures, cGMP, systems, and related documentation. Key competencies and skills required for this role include the ability to collaborate effectively, innovate for excellence, perform with accountability, lead with empathy, act with agility, demonstrate strong domain knowledge, and effectively manage people. This permanent position is located at Kurkumbh Unit 2, and the shift hours will be as per the manufacturing schedule.,

Responsible for leading production operations, coordinating production staff and equipment, ensuring product quality and profitability, and overseeing and managing the production operations involved in injectable products.

Role & responsibilities Production chemist and QC chemist Preferred candidate profile HPLC,GC wet lab,BPR,BATCH PLAN,REACTORS,ANALYSIS,WET LAB,INSTRUMENTATION, Perks and benefits As per company norms

As a highly motivated scientist joining our dynamic research team, you will be required to have an educational qualification of M.Pharm / M.Sc. (Chemistry) and possess extensive basic knowledge of modern analytical techniques. Your role will involve analyzing raw materials, in-process, and finished products while generating analytical data with accuracy and adequacy. You will be responsible for the preparation of reference, working, and impurity standards, ensuring the timely completion of assigned training modules, and maintaining the availability of consumables for experimental activities. Your expertise in handling analytical techniques such as Spectroscopy (UV-Vis, FT-IR), Chromatography (HPLC), and other instruments like Potentiometric titrator and KF will be vital for this role. Additionally, you should have knowledge of method development, stability analysis, cGMP, GLP, and GDP procedures. Understanding development activities and processes in the pharmaceutical industry is essential, along with maintaining accurate records of research activities and results. You will play a key role in maintaining a safety and quality culture, participating in lab activities to ensure compliance, and following appropriate safety practices in the workplace. It is important to actively contribute to achieving team goals, communicate information clearly and impartially, and enforce safety requirements related to your job function. This position is based on-premise, and Pfizer is an equal opportunity employer that complies with all applicable equal employment opportunity legislation. If you are a motivated scientist with a background in pharmaceutical research and the required educational qualifications and experience, we encourage you to apply to be part of our Research and Development team.,

You will be responsible for liaising between various departments such as Planning, Production, Technical Services, Marketing, and Exports. Your roles and responsibilities will include the preparation, review, and implementation of SOPs and STPs. You will be checking all QC related records like analytical reports and logbooks. Additionally, you will be involved in planning and distributing samples for the analysis of Raw Materials, Intermediates, and finished products. You will design and conduct Stability studies as per ICH Guidelines and develop and validate analytical testing methodology used to control raw materials, production intermediates, and final products. Your tasks will also include the preparation and maintenance of working standards with documents, as well as the operation and calibration of laboratory instruments like HPLC, GC, and Spectrophotometer. You will review and approve Raw material, finished product, and Packaging material specifications. Furthermore, you will be responsible for handling customer audits and regulatory authority audits and preparing compliance reports. Troubleshooting of HPLC, GC, and other instruments will be part of your responsibilities. You will manage the laboratory and work towards analytical laboratory improvement, cGMP and GLP compliance, and problem resolution. As the QA/QC Manager, you will be solely responsible for exports and quality-related issues for the unit. You will supervise QC chemists to ensure the smooth working of the department and to guarantee the best quality of products from the production. This is a Full Time position located in Byrathi, Bangalore.,

You should have a minimum of 5 years of experience in the packing department within the pharmaceutical, healthcare, or food processing industry. Your experience should include familiarity with Lean, OEE, and similar KPIs, as well as hands-on experience with UK MHRA or US FDA procedures. Additionally, you should have experience in equipment procurement, installation, startup, validation, and trial production run of a new WHO GMP compliant packing facility. As a part of your duties and responsibilities, you will be required to manage the packaging processes, ensure and control packaging activities, monitor yield losses during the packaging process, and ensure cost-effective packing material consumption on commercial batches. You will also need to initiate plans and processes to minimize manufacturing costs, complete and review batch records and documents online, prepare and review SOPs related to packaging activities, provide on-the-job training to executives and technicians regarding packaging, coordinate with QA and QC for validation and in-process checks and approvals, and maintain and monitor cGMP standards throughout the entire process activity. The office location for this position is in Surat. To apply for this job, please click the button below and provide your full name, gender, university name, and attach your CV. In the title section, clearly state the position you are applying for. We look forward to hearing from you soon!,

As the Microbiology Head at Sun Pharmaceutical Industries Ltd in Dewas, your primary responsibility will be to manage the overall site microbiology department. This includes overseeing sampling, testing, planning, qualifications, media fill program for sterile manufacturing, compliance, and upgrades of facilities and procedures. Your role will involve conducting effective reviews of the team and portfolio, providing direction and guidance to ensure product quality is maintained in adherence to GMP norms and timelines. You will be required to provide leadership and direction to achieve quality goals, organize timely microbiological sampling, testing, and release of raw materials, finished products, stability samples, water and utility samples, as well as environmental monitoring of various areas within the manufacturing blocks and warehouses. Additionally, you will be responsible for managing microbial cultures, laboratory investigations, and participating in internal, external, and regulatory inspections of microbiology operations. Ensuring compliance with GxPs, cGMPs, and safety standards in the microbiology laboratory is crucial, along with training microbiologists on techniques, aseptic practices, quality management skills, and personnel development. You will also be involved in preparing annual budgets for the microbiology section and liaising with the Corporate Micro team to implement microbial risk assessment programs. The ideal candidate for this position should be a Microbiology Graduate or equivalent with a minimum of 15 years of experience in microbiology work. Key success attributes include knowledge of regulatory requirements, compliance, collaboration, accountability, customer service orientation, planning, prioritization, attention to detail, people connect, emotional control, effective communication, and problem-solving skills. Additional responsibilities may be assigned as required.,

Hiring For EHS Head Location - Jammu (sambha) Exp. - 10- 15yrs Candidates Industry preference - Pharma API Only Interested candidates share resume on meenakshikandpal@tdsjobs.com 9815675900

Roles and Responsibilities Ensure compliance with GLP guidelines, including investigation of OOS/OOT events and vendor qualification. Maintain accurate records of GLP documents, instruments, and equipment through preventive maintenance schedules. Conduct calibrations on instruments according to CGMP requirements and perform spares management tasks. Implement LIMS system for effective inventory control and HPLC analysis. Perform CAPA activities as needed to resolve quality issues. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Organic Chemistry from a recognized university. Minimum 10-15 years of experience in pharmaceutical industry with expertise in GLP practices. Strong understanding of instrument calibration procedures under cGMP regulations. Proficiency in maintaining IQ, OQ, PQ documentation for laboratory equipment.

Quality Assurance & Control: Develop, implement, and maintain quality control systems and procedures. Ensure adherence to Good Manufacturing Practices (GMP) and relevant regulations (e.g., FSSAI, Aarush). Oversee the testing of raw materials, in-process materials, and finished products to ensure quality and safety. Review and approve Standard Operating Procedures (SOPs) and other quality-related documentation. Conduct or oversee investigations into quality issues and implement corrective and preventive actions (CAPA). Manage customer complaints related to product quality. Team Management: Lead and motivate the QC team, providing training, guidance, and performance feedback. Recruit, onboard, and manage QC personnel. Ensure effective communication and collaboration within the QC department and with other departments. Regulatory Compliance: Stay up-to-date on relevant regulations and industry standards. Ensure that the company's quality management system is compliant with regulatory requirements. Prepare and maintain documentation for regulatory audits and inspections. Documentation and Reporting: Maintain accurate and complete records of QC activities. Prepare and present reports on QC performance and trends to management. Continuous Improvement: Identify areas for improvement in QC processes and implement changes to enhance efficiency and effectiveness. Participate in continuous improvement initiatives. Other Duties: Assist in the development of new products and processes. Collaborate with other departments, such as Production, R&D, and Regulatory Affairs. Perform other duties as assigned. Qualifications and Skills: Bachelor's degree in a relevant scientific field (e.g., Chemistry, Pharmacy, Biology). Experience in quality control within the nutraceutical or pharmaceutical industry. Strong understanding of GMP, regulatory requirements, and quality management systems. Excellent analytical, problem-solving, and communication skills. Leadership and team management skills. Proficiency in QC software and tools. Meticulous attention to detail and a commitment to quality.

The Quality Assurance (QA) Executive API (Bulk Drugs) role based in Savli, Gujarat requires a candidate with 2-5 years of experience and a qualification of B.Sc / M.Sc. As a QA Executive, your responsibilities will involve ensuring compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing. You will be responsible for preparing, reviewing, and controlling SOPs, BMRs, BPRs, change controls, deviations, and CAPAs. In addition, conducting in-process checks for manufacturing and packaging activities, handling investigations for deviations, OOS/OOT results, and supporting root cause analysis are key components of this role. You will also be involved in participating in internal audits, regulatory audits (USFDA, EU, WHO, etc.), and vendor audits. Maintaining documentation for batch release, validation protocols, and quality systems, ensuring adherence to data integrity and good documentation practices (GDP), and supporting qualification and validation activities are crucial aspects of this position. Collaboration with cross-functional teams such as Production, QC, and R&D is essential for ensuring smooth operations. This is a full-time, permanent position with benefits including health insurance and Provident Fund. The work schedule is day shift with additional perks such as performance bonus and yearly bonus. The work location is in person.,

Cyano Pharma Pvt Ltd is a leading pharmaceutical organization in INDORE (MP) focused on quality, compliance, and innovation. We are looking for a highly skilled professional with strong expertise in Quality Management Systems (QMS) and Validation & Qualifications to ensure compliance with international regulatory standards (WHO, USFDA, EMA, MHRA). Key Responsibilities: Quality Management System (QMS): - Implement, maintain, and continuously improve the site Quality Management System in line with global regulatory guidelines (WHO, USFDA, EMA, MHRA). - Prepare, review, and update SOPs, quality manuals, and quality policies. - Manage change control, deviation, incident reporting, and risk management systems. - Coordinate and support internal, external, and third-party audits, ensuring timely CAPA implementation and closure. - Monitor and analyze quality metrics to drive continuous improvement initiatives. - Provide training and awareness programs for QMS procedures and GMP compliance across teams. - Act as a key contact for regulatory inspections and customer audits. Validation & Qualifications: - Prepare and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, facilities, and systems. - Lead process validation, cleaning validation, and computer system validation as per regulatory requirements. - Develop and maintain the Validation Master Plan (VMP). - Ensure periodic requalification and revalidation activities are performed according to schedules. - Review and approve all validation-related documents, including protocols and reports. - Ensure all validation activities comply with cGMP, data integrity, and documentation requirements. - Work closely with cross-functional teams (engineering, production, QC) to ensure smooth validation and qualification processes. Qualifications & Experience: - M.Pharm with 9-10 years of experience in Quality Assurance within the pharmaceutical industry. - Strong hands-on experience in QMS implementation and validation/qualification activities. - In-depth knowledge of global regulatory requirements (WHO, USFDA, EMA, MHRA). - Strong communication, documentation, and audit-handling skills. - Proficiency in MS Office (Word, Excel, PowerPoint) and quality documentation systems. - Location: Indore Benefits: - Competitive salary and performance-based incentives. - Opportunity to work on global compliance and regulatory projects. - Exposure to international audits and career advancement opportunities.,

As a Manufacturing Supervisor for Active Pharmaceutical Ingredients (API), you will be responsible for overseeing and enhancing the production processes to ensure top-notch quality, operational efficiency, and compliance with regulatory standards. Your main focus will be on driving operational excellence and supporting scale-up activities within a dynamic production setting. Your key responsibilities will include managing the entire API production process, starting from handling raw materials to delivering the final output. It will be crucial for you to maintain strict adherence to cGMP, EHS, and various regulatory norms such as ICH and CDSCO. Collaboration with R&D, QA/QC, and engineering teams will be essential for successful tech transfers and continuous process improvements. You will also be tasked with monitoring key performance indicators such as yield, batch records, equipment efficiency, and the accuracy of documentation. Additionally, providing training and guidance to staff on standard operating procedures (SOPs), safety protocols, and production practices will be a significant part of your role. To excel in this position, you should hold a Bachelor's or Master's degree in Pharmacy, Chemical Engineering, or a related field, along with a minimum of 5 years of hands-on experience in API manufacturing. Proficiency in process control, instrumentation, and documentation systems is required, as well as possessing strong leadership qualities, analytical skills, and the ability to troubleshoot effectively.,

newmark is looking for Analyst 1 - Gerald Eve to join our dynamic team and embark on a rewarding career journeyCollect, analyze, and interpret data from various sources to support business decisions and strategy development.Prepare detailed reports, dashboards, and visualizations that highlight trends, patterns, and actionable insights.Collaborate with cross-functional teams to understand data requirements and deliver accurate analytical solutions.Use statistical methods and data modeling techniques to solve business problems and improve processes.Validate data integrity and ensure accuracy in all analyses and reports.Monitor key performance indicators (KPIs) and provide regular updates to management with recommendations.

Envirocoats is looking for R&D Chemist (Powder Coatings) to join our dynamic team and embark on a rewarding career journeyDispense prescription medications and other health-related products to customers.Maintain accurate and complete records of customer transactions and medications dispensed.Ensure that medications are stored and dispensed in compliance with all applicable laws and regulations.Excellent customer service skills.Good organizational and communication skills.

Experience in Sterile injectable, specifically in vial washing and tunnel areas Sound knowledge of cGMP, aseptic operations, and production documentation. communication and team coordination. Maintain production documentation and logbooks accurately.

Execution & documentation of cleaning validation Protocol review IQ/OQ/PQ Swab & rinse sampling Regulatory audit support Coordination with cross-functional teams

Role & responsibilities 1. Drive product robustness for all products in area of responsibility and lead the third party operation team. 2. Lead and manage all TPO Process activities and process validation for products developed and manufactured at outside contract facilities. 3. This includes, providing product stewardship by ensuring the performance of all products are monitored and maintained in a validated state, supporting root cause investigations by providing Technical intelligence to deviations, technical complaints, OOS & CAPAs. 4. Identifying and executing continuous improvement opportunities, leading New Product Launch third party teams and leading technical activities related to transfers of Drug Product Manufacture and Packaging. 5. Be familiar with statistical tools to analyze data. 6. Provide third party and techno-commercial leadership in the areas of production and packaging process and process optimization using pharmaceutical processes. 7. Knowledge of all pertinent technical information related to an assigned product. Detailed knowledge of the operation, maintenance, and utility of all manufacturing and/or packaging equipment for assigned projects. Thorough familiarity with cGMPs, SOP's, relevant government regulations, and current industry standards. 8. Responsible for Techno-commercial activities for all dosage form. 9. Responsible for Sourcing / coordinate with LL/TP manufacturers for product related documents. 10. Supplier Identification: • Identifying potential suppliers capable of meeting the quality, regulatory, and supply requirements for markets. 11. Supplier Qualification and Onboarding: • Developing and implementing a robust supplier qualification process to ensure that selected suppliers meet the necessary standards and regulations in coordination with quality team. Preferred candidate profile PHARMA THANKS YOU REGARDS MILAP RATHOD (7486829377) call or whtup HR DEPARTMENT OPES HEALTHCARE PRIVATE LIMITED

As a Senior Executive in Engineering and Maintenance at Syngene International Ltd., your primary responsibility will be to lead operations in the designated section, focusing on mechanical maintenance with API Pharma experience. You will play a crucial role in ensuring adherence to safe practices, development of procedures for safe operations, and compliance with quality standards. To excel in this role, you must have a BE/B.Tech in Mechanical Engineering with a minimum of 3 to 8 years of experience in shift maintenance with API process equipment. Your technical skills should include driving a corporate culture that promotes environment, health, and safety (EHS) mindset, ensuring compliance with cGMP regulations, and maintaining high-quality output from your operating unit. Your day-to-day tasks will involve breakdown and preventive maintenance of various process-related equipment, operation and maintenance of utility equipment, and ensuring the maintenance of infrastructure and facilities. You will also be responsible for qualification activities of equipment, preparation of SOPs, maintaining house-keeping standards, and managing the supply chain for required materials and spares. In addition to your technical skills, you are expected to demonstrate strong behavioral skills such as dedication to work, a result-oriented approach, self-drive, and team coordination. Your role at Syngene International Ltd. will be instrumental in contributing to the overall success and growth of the organization. Syngene International Ltd. is an equal opportunity employer where your skills and contributions will be valued and recognized.,

You should have over 15 years of experience in Warehouse operations, including at least 7 years in a supervisory role within injectable manufacturing. Your role will require a strong understanding of regulatory requirements, cGMP, and industry best practices. You should possess proven leadership abilities and excellent communication skills to effectively work cross-functionally and resolve quality-related challenges efficiently. Previous experience in successfully facing regulatory audits, including USFDA, EU-GMP, and ANVISA is mandatory. In terms of Material Receipt and Storage, you will be responsible for ensuring that all materials are stored and handled in compliance with cGMP and regulatory requirements. Regular recording of temperature, RH, and DP in designated logbooks is essential to maintain optimal storage conditions. Warehouse Maintenance and Cleanliness will also fall under your purview. You must ensure the cleanliness and organization of the warehouse at all times. Your duties will also involve Material Handling and Dispensing, where you will be required to dispense raw materials and issue packing materials following the FIFO (First In, First Out) system. Proper handling, storage, and distribution of materials in alignment with company procedures and safety standards are vital. Compliance and Documentation are key aspects of the role. You will need to ensure compliance with cGMP standards and regulatory requirements in all warehouse operations. Maintaining up-to-date inward registers, following good documentation practices (GDP), and participating in audits and compliance assessments are crucial responsibilities. Safety and Hygiene protocols must be strictly adhered to. This includes ensuring that safety protocols and hygiene standards, including personal hygiene and gowning procedures as per SOPs, are followed by the warehouse team during work operations. Quality Risk Management is another critical area where you will be involved. Handling rejected materials, coordinating their disposition, participating in Quality Management System (QMS) activities, and conducting regular quality risk assessments are all part of maintaining quality standards in warehouse processes. Your role will require you to ensure that warehouse processes, documentation, and operations are audit-ready at all times.,