Company Description Immacule Lifesciences is a leading manufacturer of liquid and lyophilized injectables, known for its quality, innovation, and excellence. The company operates in strict compliance with Good Manufacturing Practices (GMP) and prioritizes environmental protection and workplace safety. With a global presence and dedicated research focus, Immacule Lifesciences is a preferred partner for pharmaceutical companies worldwide. Role Description This is a full-time on-site role for an Engineering QMS at Immacule Lifesciences located in Baddi. The role will involve tasks related to communication, analytical skills, project management, and expertise in manufacturing and mechanical engineering. Qualifications Strong Communication and Analytical Skills Experience in Project Management Knowledge of Manufacturing Engineering and Mechanical Engineering Demonstrated ability to work in a regulated manufacturing environment Bachelor's or Master's degree in Engineering or related field Certifications in Quality Management Systems (QMS) are a plus Show more Show less

Job Description 1. Responsible for overall activities performed in the Quality Control Department. 2. Implementing and monitoring of cGLP norms in the Quality Control Department. 3. Responsible for internal/Customer/Regulatory Audits and Preparation of Reports. 4. Implementation, Compliance and Maintenance of Quality Control SOPs. 5. Responsible for Document Management System for Raw Material, In-Process Samples, Packing Material, Finished Product and Stability Samples. 6. Managing Deviations, Change Control, Incidences with Investigations and associated CAPA. 7. Investigation of OOS,OOT & OOE in the Quality Control Department and associated CAPA. 8. To review and approve the Validation/Qualification protocol and report of the equipment installed in the Quality Control Department. 9. Arrangements of Analytical Method Transfer, Analytical Method Validation of Chemical and Micro sections. 10. Accomplishing QC Human Resources objectives by Recurring, Selecting, Training, assigning, counseling and discipline employees. 11. Meet QC financial objectives by estimating requirements. 12. Involving in self inspection, CFT meeting and functional review meeting. 13. Achieving QC operational objectives by contributing information and analysis to strategic plans and review. 14. Review and approval of analytical documents w.r.t. Data Integrity. 15. Release/ reject of Raw Materials, Packing Materials, Stability,In-Process and Finished Products. 16. To impart trainings to the subordinated and participate in the training programs organized by the company. 17. To ensure that prescribed safety precautions are being taken by the subordinates while performing analysis Show more Show less

🔧 Position: Officer / Executive 🎓 Qualification: Diploma / B.Tech (Instrumentation/Electrical) 📅 Experience: 2 to 7 Years 📍 Location: Immacule Lifesciences, Nalagarh 🔢 Vacancies: 5 Job Description: Responsible for the Preparation, Review of Standard Operating procedure Related to Engineering department. Handling and tracking of Deviation, Incident and change control. CAPA implementation, monitoring the effectiveness and its timely closure. Responsible for the investigation and finding root cause. Responsible for tracking and maintaining of all engineering related documents. Responsible to carry out the breakdown maintenance of all equipment installed in the facility. Responsible for scheduling and execution of preventive maintenance of all equipment installed in the facility. Co-ordinate for calibration activity of instruments as per calibration planner. Responsible to carry out installation of new equipment in coordination with the vendor. Responsible for all Engineering documentation, validation and Qualification. Responsible to co-ordinate re-validation activities of equipment installed in plant premises. Responsible to update the log books after completion of activities. Systematic approach to problem solving and reporting to immediate supervisor. Maintain safe and clean work environment by following current good manufacturing practices (cGMP) and standard operating procedures. Ensure proper cleaning of the area and equipment. Responsible for implementing Good Engineering practices. Implementing/following safety work permits and ensure safety activities at engineering. Responsible to execute the other activities assigned by Head Engineering. Required Skill Set: Candidates must have hands-on experience with injectable filling lines such as: B+S, Bosch, Groninger, Optima, Tofflon, Steriline, Truking, IMA, etc. Show more Show less

Project Management experience including planning, execution, project close-out, and change management. Coordination with R&D, Manufacturing, and Supply Chain team for new product development, scale-up, and plant fitment. Constant interaction with Functional heads and head of Operations for resolving the open Critical issues & resources for delivering the projects on time for targeted filings of each Financial Year. Maintain an OTIF (On time and in full) target of > 95% for all projects. Conducting meetings with the Senior management for updating the progress of the Projects. Build a Project Management Office within the company and ensure that all projects follow a standard methodology of execution, review, and closure. Build a strong team with the scientific capability to ensure that the organization is able to manage its ever-expanding portfolio of programs and products. Managing the Projects running at external partners, involving the key Functional Heads, and managing all Communications. Hire and retain best-in-class talent within the function with a view to building long-term org capabilities. Ensure business and tech transfer projects are effectively and efficiently managed, including a clear understanding of timelines, costs, and service level. Ensure all commercial business and project activities are done in compliance with Manufacturing Supply Agreements and concurrence with clients. Apply established processes and procedures and proactively suggest areas for continuous improvement to existing processes. Escalate project issues in a timely manner to management, and personnel issues to Functional management. Show more Show less

To ensure and maintain the work discipline on shop floor. Planning and execution of monthly manufacturing/packing plan and other manufacturing/packing activities. Responsible for production related tasks including production planning and process control and troubleshooting for achieving the planned periodic schedules. To ensure effective compliance of quality management system as per cGMP and international regulatory requirement in production and ancillary areas. Responsible for implementation of systems, processes and procedures to facilitate smooth functioning of overall operations. To ensure the execution of validated status of the injection facility. To ensure effectiveness of all standard operating procedures, batch document, master documents of production and compliance to documents. Assuring that the department is in compliance with cGMP/regulatory requirement. Co-ordination for new product transfers and thereafter support for process validation Co-ordination with QA for self- inspection and compliance to the audit observation. Responsible for improvement in product yield and productivity. Proper utilization of man and machine and to ensure compliance for documents as per cGMP requirement. To prepare and review capex, user requirement specification etc. To prepare and review MIS report and other related documents of production department as per requirement. To ensure that initial and continuing training of production persons has been performed as per schedule. To confirm the training matrix, training reports of new and existing employees. To ensure scheduled validation of the equipment, calibration of devices and maintenance of equipment. Responsible for planning and implementation of preventative and predictive maintenance schedules. Overseeing the recruitment, performance of subordinates, mentoring/motivating them to improve their contribution levels. Responsible for man management and administrative functions and new Project management. Responsible for implementation of system, processes and procedures to facilitate smooth functioning of overall operations enhance operational efficiency and cost optimization. Market compliant investigation jointly with QA. To comply and ensure the implementation of safety practices. To report that entire daily schedules and executions to the management. Responsible to self Inspection. Review and approval of QMS elements and process documents through Ample logic and EDCS system. Review and approval of RM, PM, consumable and other dispensing activities through ERP system. Show more Show less

Responsibilities: Equipment Design Reviews Plant Layout reviews and verified PFD & P&ID Finalization Piping Design Piping Isometrics Design philosophy Reviews Project Cost & Time Estimation Planning and Scheduling of Project Activities Budgeting Material Procurement Inspection Erection & Commissioning Managing the installation & commissioning of machines & equipments as part of project & coordination with clients for execution of projects Coordinating activities including work scheduling monitoring progress of work to ensure timely completion without any cost & time over run Checking, verifying and recording the received bills from the vendor Planning and effecting preventive maintenance schedules of Mechanical, Utility, electrical, electronics & pneumatic instruments to increase machine up time/ reliability; thereby accomplishing production targets Executing cost saving and energy saving techniques/ measures and modifications to achieve Substantial reduction and work within the budget Drive various projects for enhancing productivity, improving quality, reducing downtime, enhancing safety and energy saving as per plan Maintaining all relevant records as per ISO, WHO & cGMP standards To carry out preventive maintenance as per schedule Analyzing the breakdown cause of the machine and find out the proper remedies to eliminate it Performing the inventory for the spares Maintaining minimum spare stock in order to run smooth operation of the plant Conducting training programs for improving the technical and personnel skills in down the level staff and workers Checking daily routine work and Maintenance, Operation of BMS, Water System, HVAC System, Boiler and all other utilities To ensure the proper functioning of EHS and also perform various activities held in EHS department

We are seeking a seasoned Regulatory Affairs professional with extensive experience in injectable dossiers and a solid understanding of US FDA regulatory pathways. The ideal candidate will play a critical role in ensuring successful submissions and lifecycle management of injectable products for regulated markets, especially the United States. Key Responsibilities: Compile Abbreviated New Drug Applications (ANDAs) and Sterility Assurance Packages for ANDA filings. Submit timely responses to ANDA deficiencies (IRs, CRLs, DRLs). Handle labeling compilation, including SPL files and annotated comparisons vs. RLD labels. Prepare Controlled Correspondence with regulatory bodies for: Bioequivalence recommendations Inactive ingredient levels Q1/Q2 sameness evaluation during early development File supplements for post-approval changes (e.g., PAS, CBE-30, CBE-0). Oversee product lifecycle management, including change control approvals and continuity through effective supplement filings. Compile Marketing Authorization Applications (MAAs) for EU via DCP, MRP, and Centralized Procedure (Modules 1–5). Manage pre-ANDA meeting submissions for complex products with USFDA. Review Drug Master Files (DMFs), particularly for complex peptides. If this sounds like you—or someone in your network—please share your profile or connect with us at: 📧 pratik.joshi@acmegenerics.in

We are looking for an experienced Regulatory Affairs professional with in-depth knowledge of injectable dossiers and a strong understanding of US FDA regulatory pathways. As the ideal candidate, you will have a crucial role in ensuring the successful submission and management of injectable products for regulated markets, with a focus on the United States. Your responsibilities will include compiling Abbreviated New Drug Applications (ANDAs) and Sterility Assurance Packages for ANDA filings. You will be expected to provide timely responses to ANDA deficiencies such as IRs, CRLs, and DRLs. Managing labeling compilation, including SPL files and annotated comparisons vs. RLD labels will also be a part of your role. You will be responsible for preparing Controlled Correspondence with regulatory bodies on various aspects such as Bioequivalence recommendations, Inactive ingredient levels, and Q1/Q2 sameness evaluation during early development. Additionally, you will need to file supplements for post-approval changes like PAS, CBE-30, and CBE-0. Your role will involve overseeing product lifecycle management by ensuring change control approvals and continuity through effective supplement filings. You will also be tasked with compiling Marketing Authorization Applications (MAAs) for the EU via DCP, MRP, and Centralized Procedure (Modules 15). Managing pre-ANDA meeting submissions for complex products with the USFDA will be one of your key responsibilities. You will also be expected to review Drug Master Files (DMFs), especially for complex peptides. If you feel that you are the right fit for this position, or if you know someone who might be suitable, please share your profile or connect with us at pratik.joshi@acmegenerics.in.,

The ideal candidate is a motivated, organized, and creative individual who welcomes the challenges of acquiring and developing new business through sales efforts. You will build key customer relationships, identify business opportunities, and close business deals while maintaining an extensive knowledge of current market conditions. Responsibilities Lead Generation & Prospecting: Identify and qualify new business opportunities with pharmaceutical, biotech, and life sciences companies requiring CDMO services. Client Relationship Management: Build and nurture strong, long-term relationships with prospective and existing clients to understand their development and manufacturing needs. Proposal Development: Collaborate with internal technical, project management, and finance teams to develop proposals, quotes, and presentations tailored to client requirements. Contract Negotiation: Lead contract discussions, ensuring alignment between client expectations and company capabilities while maintaining profitability. Market Intelligence: Monitor industry trends, competitive landscape, and customer needs to refine BD strategy and identify growth areas. Sales Forecasting & Reporting: Maintain an accurate sales pipeline, forecast revenue, and report performance metrics to senior leadership. Cross-Functional Collaboration: Work closely with R&D, operations, regulatory, and quality teams to ensure successful onboarding and execution of new projects. Event Participation: Represent the company at trade shows, conferences, and networking events to build visibility and generate leads. Qualifications Bachelor’s degree in Pharmaceuticals (Master’s or MBA preferred). 5+ years of experience in business development, sales, or account management within a CDMO, CMO. Strong understanding of the pharmaceutical product lifecycle, from preclinical development through commercial manufacturing. Proven track record of meeting or exceeding sales targets. Excellent communication, negotiation, and presentation skills. Ability to work independently in a fast-paced, dynamic environment.