97 Parenteral Jobs

Please share you cv in below email ID with updated cv on renu.kumari@adecco.com Watsapp :8758695449 To supervise all activities in parenteral department, Visual inspection area, external vial washing and freeze dryer technical area activities. To supervise all activities in oncology parenteral department, Visual inspection area, external vial washing and freeze dryer technical area activities. Roles and Responsibilities To ensure cGMP compliance in the department. To ensure area, equipment and line clearance and cleaning of equipment before startup of the operation. To ensure that after completion of operation line closure activity should be performed in accordance with SOPs. To ensure that deviation, change control, CAPA is generated as and when required. To maintain the area cleanliness and arrangement before and after completion of activities. To provide technical support relating to equipment utilized in the area by repairing, maintaining and modifying production equipment utilizing technical expertise, technical manuals, precision tools and test equipment. To provide the versatility training and development of the team members. To prepare the SOPs related to area and contribute to revision of SOPs. To prepare MPCR and to ensure the production operations are followed as per the MPCR. Responsible for completion of all documentation in a timely manner and to ensure that all the

Role & responsibilities Lead formulation and development projects from concept through commercialization Design and optimize formulations to meet product specifications and regulatory requirements Manage and mentor a team of formulation scientists and technicians Collaborate with cross-functional teams including QA, QC, regulatory, and manufacturing Ensure timely completion of project milestones and deliverables Prepare technical reports, presentations, and documentation Stay updated on industry trends, regulatory changes, and best practices Qualifications Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or related field Minimum of 2-3 years of experience in formulation and development Proven track record of successful product formulations Strong understanding of regulatory requirements and guidelines Excellent project management and leadership skills Strong analytical and problem-solving abilities Fluent English International Travelling - Targeted Country - Ghana, Africa, Nigeria, Ethiopia, Uganda, Kenya, Myanmar, Thailand etc. Skills Formulation development Project management Analytical techniques Regulatory compliance Team leadership Technical writing Problem-solving Benefits Yearly Bonus Provide PF, ESIC, PT Benefits Medical Insurance Travelling Allowances Yearly Increment

Titlle : Manager 1 Engineering Educational Qualification : B Tech/BE Electrical/ Electronics & Instrumentation Engineering Experience: 14 years & above Requirement : 1. To ensure prompt attention and resolve issues of all operational and breakdown maintenance activities related to Utilities, HVAC System, and Water System. 2. To ensure timely execution of Preventive Maintenance of Utilities, HVAC System, Water System & Process Machineries performed as per the SAP schedule and maintain accurate record of the same. 3. To provide Technical assistance & Support for efficient operation of ETP. 4. Review and approve QMS related activities in EDMS & Trackwise systems to ensure compliance and documentation Integrity. 5. Responsible for Compliance of Internal & External Audits. 6. Tracking WBS code for all, CAPEX, Projects & Aspire Projects 7. Conduct Monthly review of MTTR, MTBF & KPIs 8. Following up with OEM, third Party service s & AMC to ensure timely service delivery and issue resolution. 9. Maintaining and ensuring Safety and discipline for all engineering related work and personnel of Engineering. 10. To provide Training to Subordinates to enhance their operational efficiency. 11. To performed any other duties assigned by HOD.

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.

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.

Good knowledge of cGMP, documentation practices, and regulatory requirements. Experience with visual inspection, labeling, sealing, and secondary packaging.

Job Title: Production Manager Department: Production Production Manager Injectables with full manufacturing knowledge including formulation, filling, sterilization, and packaging. Strong technical knowledge of sterile/injectable manufacturing. Supervise and manage day-to-day production activities for injectable formulations. Prepare and review production plans, BMRs, SOPs, and validation protocols. Key Responsibilities: Formulation / Compounding Filling & Sealing Sterilization Visual Inspection Packaging Team Management & Training

Multiple Positions open for Officer/Manager Role & responsibilities : Managing the production line with end to end responsibility for Quality and Quantity. Also required to complete requisite documentation and MIS as desired by management. Preferred candidate profile: S cience Graduate with 3-11 years of experience in managing Filling Lines/Batch Manufacturing/Packing operations in the pharmaceutical industry. Preference will be given to candidates with Injectable operations experience. Should be able to handle 6-10 supervisors Perks and benefits : Best in Industry salaries, growth opportunities within the organization and a fair minded organization which respects individuals as contributors.

Title: Block Head (Parenteral Production) Job Grade: G8 Deputy General Manager Educational Qualification: B.Pharm / M.Pharm Location: Baska, Gujarat Experience: Knowledge of parenteral manufacturing operations Understanding regulatory guidelines Leadership & Team Management Skills Problem Solving & Decision-Making Proficiency in handling production documentation & compliance Min. 15 years of experience working in sterile manufacturing plant or Block In-charge experience Position Summary Responsible for plant operations from material procurement to product dispatch along with operational activities, manufacturing actions, lean management, training, regulatory compliance, cross functional coordination, new product projects, new CAPEX projects, safety and administrations. Monitoring and control of the manufacturing environment, plant hygiene, compliance to requirement of current Good Manufacturing Practice, EHS, local and international regulatory norms. To coordinate for external/regulatory GMP audits at plant and to ensure timely compliance of audit observations. Optimum utilization of man, material and machinery of pharmaceutical products and assuring adequate resource arability with focus of safety and quality first. Ensuring lean management, operation excellence, GEMBA, yield improvement and waste reduction etc. with action plan and its implementation. Responsible to review and approve the qualification related documents as URS, DE, FAT, SAT, IQ, OQ, PQ etc. To coordinate with FDD/PDD (R&D)/ MSTG for execution of trial/ exhibit/ process validation batches and trouble shooting. Implementation of effective control on budgetary provisions and cost reduction measures. Supervision of proper production planning, plan execution as per schedule and ensure that products are produced and stored according to appropriate safety, cGMP requirement. Ensuring protection of the product from contamination and maintain quality as required. Participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.

Titlle : Manager 1 Engineering Educational Qualification : B Tech/BE Electrical/ Electronics & Instrumentation Engineering Experience: 14 years & above Requirement : 1. To ensure prompt attention and resolve issues of all operational and breakdown maintenance activities related to Utilities, HVAC System, and Water System. 2. To ensure timely execution of Preventive Maintenance of Utilities, HVAC System, Water System & Process Machineries performed as per the SAP schedule and maintain accurate record of the same. 3. To provide Technical assistance & Support for efficient operation of ETP. 4. Review and approve QMS related activities in EDMS & Trackwise systems to ensure compliance and documentation Integrity. 5. Responsible for Compliance of Internal & External Audits. 6. Tracking WBS code for all, CAPEX, Projects & Aspire Projects 7. Conduct Monthly review of MTTR, MTBF & KPIs 8. Following up with OEM, third Party service s & AMC to ensure timely service delivery and issue resolution. 9. Maintaining and ensuring Safety and discipline for all engineering related work and personnel of Engineering. 10. To provide Training to Subordinates to enhance their operational efficiency. 11. To performed any other duties assigned by HOD.

1. Preparation, review and revision of SOPs, GTPs and Work sheets. 2. Execution of analytical method validation protocols for product samples. 3. Testing and review of product / Miscellaneous samples for AET. 4. Operation and maintenance of laboratory Instruments. 5. Monitoring of temperature, DP and RH of the Microbiology laboratory. 6. Involve in the execution of Media fill validations. 7. Cleaning, verification of laboratory cleaning and glassware cleaning in the Microbiology laboratory. 8. Receipt, storage, preparation, sterilization and maintenance of sterile media and reagents. 9. Performing the isolation, identification and confirmation tests for test organisms and Isolates. 10. Responsible for Growth promotion, inhibition test of Microbiological culture media. 11. Responsible for Biological indicator qualification, usage and testing. 12. Culture maintenance in Microbiology department. 13. Preparation and usage of disinfectants. 14. Review of outside COAs. 15. Review, checking and verification of all types Microbiology laboratory documents. 16. Responsible for implementation activities related to resource manager and sample manager of Laboratory information management System #40;LIMS#41;. 17. Verification of cleaning in the Microbiology laboratory. 18. Responsible for compliance to cGLP.

1. Operation and maintenance of Instruments. 2. Receipt, storage and usage of microbiological dehydrated media and other microbiology laboratory consumables. 3. Reconciliation and maintenance of sterile media. 4. Preparation of dilute disinfectants, cleaning, reagents solutions / indicator solutions. 5. Responsible for handling of Bio-waste in Microbiology department. 6. Monitoring of temperature, DP and RH of the Microbiology laboratory. 7. Preparation, sterilization and maintenance of sterile media and reagents. 8. Review, checking and verification of all types Microbiology laboratory documents. 9. Verification of cleaning in the Microbiology laboratory. 10. Responsible for compliance to cGLP. 11. Performing the isolation, identification and confirmation tests for test organisms and Isolates. 12. Responsible for Growth promotion, inhibition test of Microbiological culture media. 13. Responsible for Biological indicator qualification, usage and testing. 14. Culture maintenance in Microbiology department. 15. Preparation and usage of disinfectants. 16. Any job allotted by Department head.

1. Following GMP, safety practices in production facilities and work place. 2. Responsible for buffer preparation activities Area drains cleaning and documents updation. Verification and receiving of material required for buffer preparation activities. Execution of Buffer preparation activities. Preparation of area, equipments before batch activities. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Updation of room / equipment status labels. Arrangement of sterile material. 3. Handling of documents Updation of log books. Updation of BMRs and protocols/reports 4. Responsible for operation of following production equipments Mixing systems Conductivity meter Weighing balance Peristaltic pumps Walk in Cold room Freezer room Magnetic Stirrer pH meter Heat exchanger 5. Attending training on SOP's / GMP as per schedule

• Communicate and collaborate with subordinates on goals. • Ensure complete strategy/system implementations as per directives • Induct new employee as per companys policy, ensuring no deviation while practicing policies and code of conduct • Guide team members to resolve issues, dealing with stockist & chemist. • Prepare and submit the tour programme for self and team as per the guidelines • Monthly analysis of Primary/ Secondary sales, customer coverage etc • Build business relationships with key customers • Brief sub-ordinates on the incentive scheme • Ensure Annual target Achievement of all HQ • Ensure achievement of all New Launches If Interested and have relevant experience, requesting you to share your CVs on : narendra.nathani@zuventus.com

• Communicate and collaborate with subordinates on goals. • Ensure complete strategy/system implementations as per directives • Induct new employee as per companys policy, ensuring no deviation while practicing policies and code of conduct • Guide team members to resolve issues, dealing with stockist & chemist. • Prepare and submit the tour programme for self and team as per the guidelines • Monthly analysis of Primary/ Secondary sales, customer coverage etc • Build business relationships with key customers • Brief sub-ordinates on the incentive scheme • Ensure Annual target Achievement of all HQ • Ensure achievement of all New Launches If Interested and have relevant experience, requesting you to share your CVs on : narendra.nathani@zuventus.com

• Communicate and collaborate with subordinates on goals. • Ensure complete strategy/system implementations as per directives • Induct new employee as per companys policy, ensuring no deviation while practicing policies and code of conduct • Guide team members to resolve issues, dealing with stockist & chemist. • Prepare and submit the tour programme for self and team as per the guidelines • Monthly analysis of Primary/ Secondary sales, customer coverage etc • Build business relationships with key customers • Brief sub-ordinates on the incentive scheme • Ensure Annual target Achievement of all HQ • Ensure achievement of all New Launches If Interested and have relevant experience, requesting you to share your CVs on : narendra.nathani@zuventus.com

Business Development GIFT City Branch Department BMU Location Gandhinagar Number of Positions 01 Reporting Relationships VP GIFT City Position Grade M5 (AVP) Kotak Mahindra Bank Gift City Branch is the International Financial Services Center Banking Unit [IBU] set up in Gujarat International Finance Tec - (GIFT) City. It deals with non-individual entities across the globe for their funding (Non INR) requirements; extending ECBs to Indian corporates, Trade and other transaction banking products. Business development Liaising with various business groups in KMBL for lead generation Liaising with various banks globally for borrowing / lending Liaising with various product teams / subsidiaries of KMBL to explore permissible business opportunities Documentation, negotiation and Conclusion of transactions Product structuring Understanding client requirements Liaising with compliance, risk and product teams Setting up process flow for the product Keep the business teams updated with the regulations and products availability. Salary Budget- 19 LPA to 23 LPA Experience Required- 10 to 12 Years Reporting- SVP/ EVP

Role & responsibilities (Production): Assist in manufacturing operations of parenteral dosage forms (sterile injections) as per SOPs and GMP guidelines. Monitor and record process parameters during manufacturing and filling operations. Ensure compliance to cGMP, documentation and data integrity norms. Support continuous improvement initiatives in production efficiency and compliance. Role & responsibilities (Engineering): Assist in preventive maintenance and breakdown handling of production equipment Support engineering team in equipment qualification and calibration activities. Monitor Utility systems Maintain proper documentation as per GMP norms. Follow safety protocols and support new initiatives Preferred candidate profile Basic knowledge of sterile/aseptic manufacturing / pharma production equipment Interest in plant maintenance Willingness to work in shifts & controlled environment Good documentation and communication skills Attention to detail and compliance mindset Good observations and analytical skiils

Role & responsibilities Responsible for Pre-formulation studies for lab formulation development trials of solid orals, Oral Liquid, injectable, products, and Nutraceuticals product. To design strategy for projects through literature surveys. Respective API characterization, excipients characterization, drug and excipient study and its ratio. Worked on different manufacturing strategies for the development of products. To evaluate product for stability in manufacturing, monitor and review the stabilized batches. To study on existing formulations. Responsible for co-ordination, execution and monitoring of scale up activity, Responsible for Trial batches, Scale up batches, Optimization batches, Exhibit batches. Co- ordination with all cross-functional teams. TT sites and LL Sites To design/assist/support/ review for documents such as SOP, LNB, QQ, Risk assessment, PDR, MFR, Scale up BMR, stability protocol, qualification, validation documents, change controls, deviations, investigations and CAPAs etc. Preferred candidate profile pharma THANKS YOU REGARDS MILAP RATHOD (7486829377) any time call me or whtup HR DEPARTMENT OPES HEALTHCARE PRIVATE LIMITED

Role & responsibilities 1. Follow the instruction & procedure given in Entry- Exit SOP (Standard Operating Procedure) of Grade C, decartoning area and Grade B’ area. 2. Responsible a procedure for proper functioning or behaviour in aseptic area. 3. Follow the personnel hygiene practices in factory premises. 4. Follow the GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) as per given in SOP. 5. Responsible for monitoring of temperature, relative humidity and differential pressure. 6. Responsible for monitoring of differential pressure of laminar air flow units and pass boxes. 7. Responsible for handling of material movement in production area. 8. Responsible for maintain the document as per GDP and area as per cGMP. 9. Responsible for to maintain day to day records. 10. Responsible for training to new joining chemist, workers and operators for their respective job. 11. Carrying out the line clearance before starting the operation. 12. Responsible for planning of manufacturing as per availability of RM and PM. 13. Responsible for supervision of preparation and filtration of cleaning/ disinfectant solutions and fogging solutions. 14. Responsible for supervision of equipments/ machines and utility readyness before batch manufacturing. 15.Responsible for supervision of operation and cleaning of steam sterilizer, compounding vessel and holding vessel, vial washing machine, sterilization and depyrogenation tunnel, washing and drying and wrapping of garments and pass box and laminar air flow. 16. Responsible for supervision of handling of filters, filter integrity testing apparatus, silicon tubing, decartoning area and hose pipes and cleaning and wrapping of glassware, auxiliary items and machine parts. 17. Responsible for supervision of operation of pH meter and stirrer. 18. Responsible for supervision of aseptic process stimulation, post media fill cleaning and sanitization of machine and area as per procedure. 19. Responsible for destruction of media filled vials. 20. Responsible for supervision for general area cleaning and sanitization of grade ‘C’ and ‘D’ area and fogging activity of respective area. 21. Responsible for verification of load cell. 22. Responsible for verifying the handling of waste generated in production area. 23. Responsible for non viable particle count (online and offline) monitoring. 24. Recording the operation and cleaning details in batch manufacturing record and equipment uses log book. 25. Responsible for handling of equipment like homogenizer, rota evaporator, magnetic stirrer, ultrsonicator, pH meter and fogger. 26. Follow the procedure for dispensing room and responsible for RM and PPM dispensing and additional materials issuance. 27. Responsible for all data entry for batch manufacturing process in pharmacloud system. 28. Responsible for audit preparation and execution. 29.To undergo periodic medical checkup arranged by the company. 30.Performing the task assigned by the supervisor. 31. Reporting regarding unsafe act/ unsafe condition/ accident/ incident to supervisors. Preferred candidate profile Candidate Should have Exposure of Pharma Injectable Plant. Candidate Should well familiar with Pharma Guidelines. Candidate should have good Verbal and Written Communication Willing to Relocate in Navsari, Gujarat, Willing to Work in a Shift.

Overview We are seeking a highly organized, proactive, and detail-oriented Executive Assistant to support our Senior Vice President (SVP). This role requires a high level of professionalism, discretion, and the ability to anticipate needs while managing a wide range of administrative and executive support tasks in a fast-paced environment. Responsibilities Manage and optimize the SVPs calendar, scheduling meetings, appointments, and travel arrangements. Prepare, review, and organize correspondence and other confidential documents. Coordinate internal and external meetings, including logistics, agendas, and follow-ups. Serve as a liaison between the SVP and internal/external stakeholders. Handle expense reports, invoices, and budget tracking as needed. Maintain strict confidentiality and discretion in all interactions. Taking care of all activities related to SVPs office. Visa processing. Maintaining & Updating tracking tracker. Qualifications Bachelors degree preferred; equivalent experience considered. Minimum of 5 years of experience in an executive support role, preferably supporting C-level or SVP executives. Exceptional organizational, time management, and multitasking abilities. Strong verbal and written communication skills. Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); familiarity with collaboration tools like Teams and Concur is a plus.

Novo Nordisk Global Business Services (GBS) India Department GCM DP RoW Job Location Hyderabad Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global healthNovo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you''ll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). ! The Position As a Manufacturing Specialist (SME), you''ll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top-tier quality with our Contract Manufacturing Organizations (CMO) partners. Your key responsibilities will include: Lead cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMOs) partners as the receiving Unit. Act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards. Provide training, share best practices, and review and approve validation documents to safeguard compliance. Offer oversight and support during the planning and execution of validation and qualification activities. Define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers. Drive problem-solving initiatives and provide scientific and technical solutions within tight project timelines. Qualifications Bachelor’s /Master’s degree in engineering. Possess 10+Years experience and relevant 5 years of manufacturing experience, especially in an international, multicultural environment. Expertise in aseptic manufacturing processes is non-negotiable. Capable of communicating naturally and effectively with stakeholders at all levels with adept at finding solutions and motivating stakeholders to achieve ambitious goals. Possessing a strong mindset, a focus on continuous improvement, and keen attention to detail. Demonstrates the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment. About the Department GCM DP RoW Projects is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity. With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, you’ll join a diverse and dynamic team committed to making a difference.

Novo Nordisk Global Business Services (GBS) India Department: GCM DP RoW Location Hyderabad, India Are you an experienced aseptic manufacturing project manager with a strong technical background and a passion for making a direct impact on patients'' livesDo you thrive in an international environment where cultural awareness is key to your successIf so, this could be your dream role! ApplyNow! The Position As a Project Manager in Aseptic Manufacturing, you will lead and mentor cross-functional teams, including both Novo Nordisk and our Contract Manufacturing Organisation (CMO) partners. It includes, Ensure the seamless Technology Transfer and manufacturing of our commercial products, always upholding Novo Nordisk''s stringent quality standards and adhering to cGMP and regulatory requirements. Lead and manage aseptic manufacturing projects, specifically leveraging your expertise in areas like Formulation/Compounding, Filling, Washing & Sterilisation, Environmental Monitoring, or Clean Utilities. Developing and managing detailed project plans and timelines and communicating effectively with steering groups and key stakeholders. Monitoring progress and proactively securing necessary resources. Developing project risk grids and identifying mitigation strategies with both Novo Nordisk and our Contract Manufacturing Organisation (CMOs). Qualifications Bachelor’s or Master’s degree in engineering. Possess experience of 5-12Years of project management experience with a proven track record of successful project delivery in a highly regulated environment, especially internationally. Aseptic manufacturing experience is a must, and experience with Technology Transfer of biologics is a significant advantage. Professional experience balancing individual drive with effective stakeholder involvement. Proficiency in project management software (e.g., MS Project, Smartsheet, Jira, or equivalent). Demonstrated fluency in written and spoken English is essential. About the Department GCM DP RoW Projects is a dedicated team committed to providing life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department strives to make a meaningful impact on the quality of life for patients living with diabetes and obesity. Our projects are tailored to meet the unique requirements of each country, offering exciting growth opportunities. With a steadfast commitment to innovation and problem-solving, we work to overcome challenges and navigate complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Join us in making a difference.

Senior Manager Quality Assurance – Formulation Injectables Quality Assurance – Sterile Formulations Reports To: Cluster Head – QA Qualification: M.Sc / M.Pharm (Pharmaceutical Sciences / Quality Assurance / Microbiology or related) Experience: 15–20 years of experience in Quality Assurance for sterile injectable formulation manufacturing. Job Purpose: To lead the Quality Assurance function for sterile injectable formulations by ensuring effective implementation of quality systems, compliance with regulatory requirements, and oversight of batch release, documentation, validation, and all related QA activities in a cGMP-compliant environment. Key Responsibilities: 1. Quality Oversight & Team Leadership Lead QA functions across sterile injectable manufacturing lines. Allocate responsibilities and monitor performance of QA team members. Ensure adherence to cGMP, quality systems, and regulatory compliance. 2 . Batch Release & Documentation Control Review and approve Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and analytical data. Perform batch disposition (release or reject) based on thorough quality review. Ensure control and lifecycle management of documents such as SOPs, BMRs, BPRs, STPs, and specifications. 3 . Quality Management System (QMS) Develop, review, and upgrade QMS policy documents like Site Master File (SMF), Quality Manual, and Cross-Contamination Strategy. Monitor and review QMS activities such as: Change Controls Deviations CAPA (Corrective and Preventive Actions) OOS/OOT Market complaints and recalls APQR (Annual Product Quality Review) 4. Validation & Qualification Ensure execution and compliance of validation programs: Process validation Cleaning validation Equipment qualification (IQ, OQ, PQ) Facility and utility qualification Define IPQA procedures and oversee their effective execution. Review and approve validation protocols and reports. 5. Regulatory Compliance & Audit Readiness Ensure readiness for national and international regulatory inspections (USFDA, MHRA, EU-GMP, WHO). Prepare and review responses to inspection observations. Guide QA teams during internal and external audits. 6. Calibration, Maintenance & Environmental Monitoring Review schedules and compliance for calibration of instruments and preventive maintenance of equipment. Ensure compliance with environmental monitoring and microbial controls in sterile areas. 7. Electronic Systems & Quality Tools Review and approve documents generated electronically via platforms such as: DMS (Document Management System) QAMS (Quality Assurance Management System) LIMS (Laboratory Information Management System) NICHELON, CLEEN, or other enterprise QMS tools 8. Training & Continuous Improvement Identify training needs for QA staff and ensure implementation. Drive continual improvement initiatives in quality systems and compliance culture. Key Skills & Competencies: Strong knowledge of aseptic/sterile injectable formulation processes Deep understanding of global regulatory guidelines (USFDA, EMA, WHO, etc.) Excellent documentation and data integrity compliance Leadership, team management, and decision-making abilities Proficient in use of electronic QMS tools Preferred Candidate Profile: Successfully led QA functions for sterile injectable manufacturing facilities. Handled regulatory audits (USFDA, EU, MHRA, TGA, WHO). Experience in technology transfer and product lifecycle management. Ability to interface effectively with cross-functional teams (QC, Production, RA, Engineering).

Walk-in @ Indore We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned, If any of the requirement is matching your current job profile, kindly walk-in with your latest resume. *Job Location: Matoda, Ahmedabad, Gujarat. Engineering (Instrumentation / QMS / Process Equipment maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech with relevant functional experience in Calibration / Instrumentation / QMS activities QUALITY ASSURANCE QMS / Documentation / Validation and Qualification / IPQA (OSD) (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. QUALITY CONTROL (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M.Sc. (Organic Chemistry / Analytical Chemistry) B. Pharmacy / M Pharmacy MICROBIOLOGY (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M. Sc (Microbiology) Injectable Manufacturing (Executive/Senior Officer / Officer / Associate) Experience - 01 to 06 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma with relevant functional experience in injectable manufacturing/ Aseptic area operations / Visual inspection / QMS activities OSD Manufacturing (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Diploma with relevant functional experience in OSD manufacturing operations / QMS activities Time and Venue : 20th July 2025 09:30 Hrs to 18:00 Hrs ______________________________________________________ PAPAYA TREE Group of Hotels - Indore, Address: AB Road , Near Dr. Hardia Eye Clinic, Rau, Indore, MP ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. Note: Having relevant qualification only can attend the scheduled walk-in.