Kopran

Role & responsibilities 1. Preparation of DMFs for regulated (US, EU) & ROW markets. 2. Preparation of lifecycle management submissions (amendments / revisions) for the filed DMFs. 3. Preparation of response to deficiencies from regulatory authorities & customers. 4. Review of the data for DMF preparation received from mfg. site and R&D and ensuring required corrections. 5. Coordination with cross functional teams for data / documents. Review of the DMFs & other submissions prepared by the team. Preferred candidate profile 1. Candidate should be M.Sc. Chemistry with 6-8 years experience OR B.Sc. - Chemistry with 8 years plus relevant work experience in a reputed pharma industry, preferably in API RA. 2. Should possess good knowledge of ICH guidelines and regional regulatory requirements for US, EU, Brazil & other ROW markets. 3. Should have individually handled DMF & deficiency response submissions. Should have strong analytical & interpersonal communication skills.

Role & responsibilities: 1. Preparing order processing 2. Preshipment documentation 3. Post shipment documentation 4. Bank documents - letter of credit, CAD, DA, Advance Payment 5. Preparing Proforma invoice 6. Certificate of origin / AIFTA 7. Insurance certificate 8. MIS reports

Strategic sourcing mainly of API Domestic and imported CEP / DMF grade of API RLD (Reference listed products) for generic new product development-Domestic as well as imported Well verse of all formalities like import licenses etc Project management –interface between R&D. Prepare and issue purchase orders. Monitor inventory levels and place orders for replenishment. Collaborate with suppliers to negotiate favorable terms and conditions. Manage supplier relationships and ensure timely delivery of goods. Conduct regular price comparisons to identify cost savings opportunities. Coordinate with internal departments to ensure smooth product transfers from suppliers to warehouses. Maintain accurate records of all purchases and related expenses.

Role & responsibilities Must be capable of managing a regulatory team consisting of 10 to 15 individuals. Compile and submit regulatory documents, applications, and reports to regulatory authorities such as those in the UK, EU, and Canada. Convey regulatory requirements and guidelines to internal departments, such as research and development, manufacturing, and quality assurance. Serve as a point of contact between the organization and regulatory bodies, participating in meetings and addressing inquiries. Formulate and execute regulatory approaches for product development, approval, and post-market monitoring. Gather, evaluate, and oversee data related to regulations, encompassing clinical trial information and post-market monitoring data. Perform risk evaluations concerning regulatory compliance and create strategies for mitigation. Review and approve regulatory-related documentation, including labeling, marketing materials, and user manuals.

Role & responsibilities 1. Manage and oversee store operations at the formulation plant. 2. Ensure compliance with Good Manufacturing Practices (GMP) in all store activities. 3. Maintain accurate inventory records using computer systems; strong computer knowledge is essential. Lead, guide, and supervise the stores team for efficient workflow and coordination.

Role & responsibilities 1. Oversee the procurement of all types of packaging materials. 2. Analyze costing data for effective purchasing decisions. 3. Possess strong negotiation skills to ensure cost efficiency. 4. Must have experience in procurement within a formulation unit. 5. Identify, evaluate, and select suppliers, negotiate contracts, and manage relationships to ensure quality, reliability, and cost-effectiveness. Negotiate contracts and deals with suppliers to secure favorable terms and pricing. Preferred candidate profile Candidate should be from Pharmaceutical Industry with diploma Institute of Packaging

QC Role & responsibilities : Handling of QC instruments, Such as HPLC, GC, UV, FTIR, Dissolution Apparatus, Melting point, Karl Fischer apparatus, Auto titration, Analytical weighing Balance, Polari meter, Disintegration Apparatus, pH Meter etc. Analysis of In process, validation, Hold time study, finished products and stability samples according to related specifications Daily as well as monthly calibration of analytical balance of instrumentation section To maintain the daily logs adhering to the Good Laboratory Practices. Daily standardization of Karl Fischer reagent. Daily temp recording of instrumentation room, chemical room & refrigerator. Daily preparation of 0.4% NaoH for discarded penicillin sample deactivation. Regular, online analysis of cleaning (Rinse & swab) samples. QA Role & responsibilities : Execute and review Equipment Qualification protocols (IQ, OQ, PQ) in compliance with regulatory requirements. Prepare, execute, and review Cleaning Validation protocols and reports. Participate in the design, execution, and documentation of Computer System Validation (CSV) as per GAMP 5 guidelines. Coordinate and support Process Validation activities, including preparation and review of protocols, execution, and final reporting. Ensure that all validation activities are compliant with cGMP, regulatory guidelines, and internal SOPs. Perform gap assessments, risk assessments, and deviation handling related to validation. Collaborate with cross-functional teams including production, engineering, QC, and IT for validation planning and execution. Assist in internal audits, regulatory inspections, and prepare responses to audit observations. Maintain and update validation master plans and SOPs regularly.

Role & responsibilities Operate and maintain QC instruments, including HPLC, GC, UV, FTIR, Dissolution Apparatus, Melting Point Apparatus, Karl Fischer Apparatus, Auto Titration, Analytical Weighing Balance, Polarimeter, Disintegration Apparatus, pH Meter, etc. Perform analysis of in-process samples, validation, hold-time study, finished products, and stability samples as per relevant specifications. Conduct daily and monthly calibration of analytical balances in the instrumentation section. Maintain daily logs and ensure adherence to Good Laboratory Practices (GLP). Perform daily standardization of Karl Fischer reagent. Monitor and record daily temperature readings of the instrumentation room, chemical room, and refrigerator. Prepare 0.4% NaOH solution daily for the deactivation of discarded penicillin samples. Conduct regular and online analysis of cleaning (rinse & swab) samples Preferred candidate profile Hands-on experience with laboratory instruments and analytical techniques. Knowledge of GLP, GMP, and regulatory guidelines. Strong documentation and record-keeping skills. Ability to work in a fast-paced, compliance-driven environment. Attention to detail and problem-solving skills.

Role & responsibilities Execute and review Equipment Qualification protocols (IQ, OQ, PQ) in compliance with regulatory requirements. Prepare, execute, and review Cleaning Validation protocols and reports . Participate in the design, execution, and documentation of Computer System Validation (CSV) as per GAMP 5 guidelines. Coordinate and support Process Validation activities, including preparation and review of protocols, execution, and final reporting. Ensure that all validation activities are compliant with cGMP, regulatory guidelines , and internal SOPs. Perform gap assessments, risk assessments , and deviation handling related to validation. Collaborate with cross-functional teams including production, engineering, QC, and IT for validation planning and execution. Assist in internal audits, regulatory inspections , and prepare responses to audit observations. Maintain and update validation master plans and SOPs regularly. Skills & Competencies B. Pharm / M. Pharm / M.Sc. in relevant field. Minimum 4 years of hands-on experience in QA validation functions in a regulated pharmaceutical manufacturing environment. Strong understanding of equipment and utility qualification, cleaning validation, CSV, and process validation . Familiar with guidelines such as GAMP 5, 21 CFR Part 11, ICH Q8-Q10 , and applicable regulatory standards. Good documentation and analytical skills. Proficient in MS Office , knowledge of QMS software is an advantage. Strong communication and coordination skills.

Role & responsibilities Operate and monitor tablet coating machines (Auto Coater/Conventional Pan) as per batch manufacturing records (BMR). Perform coating processes (aqueous/organic) ensuring uniformity and quality standards. Set and monitor machine parameters (spray rate, pan speed, inlet/outlet temperature, atomizing pressure, etc.). Carry out equipment cleaning, calibration, and preventive maintenance. Record all operational details in BMR, logbooks, and related documents. Coordinate with QA/QC for in-process checks and ensure compliance. Report deviations, breakdowns, and abnormalities immediately. Maintain proper stock of coating materials and consumables. Follow cGMP, GDP, safety, and EHS guidelines strictly. Preferred candidate profile Hands-on experience in coating operations (auto coater/manual). Knowledge of coating polymers, suspension/solution preparation, and coating defects. Strong understanding of cGMP, GDP, and regulatory standards. Ability to troubleshoot coating process issues. Good documentation and communication skills.

Role & responsibilities Operate and monitor tablet compression machines (e.g., Cadmach, Fette, Korsch, or equivalent). Set and adjust machine parameters (RPM, compression force, weight, thickness, hardness, etc.) as per BMR. Ensure proper tooling installation, changeover, and maintenance of punches & dies. Perform in-process checks (IPC) like weight, thickness, hardness, friability, and appearance. Record all operational activities in BMR, logbooks, and other documents as per GDP. Ensure line clearance, cleaning, and preventive maintenance of machines. Report deviations, breakdowns, and abnormalities to supervisors/engineering. Adhere strictly to cGMP, GDP, EHS, and safety guidelines during operations. Coordinate with QA/QC for quality checks and ensure compliance with standards. Preferred candidate profile Hands-on experience in operating high-speed compression machines. Knowledge of punch & die handling, tooling maintenance, and compression defects. Strong understanding of cGMP, GDP, and regulatory guidelines. Troubleshooting skills for machine and product-related issues. Good documentation and communication skills.

Role & responsibilities Operate RMG, FBD, Multi Mill, and related granulation equipment as per BMR and SOP. Carry out wet granulation, drying, sizing, and blending processes. Set machine parameters and monitor process conditions (impeller/chopper speed, inlet/outlet temperature, drying time, etc.). Prepare and handle binder/solution as per production requirement. Ensure proper cleaning, line clearance, and preventive maintenance of equipment. Record production activities in BMR, logbooks, and other documents as per GDP. Coordinate with QA/QC for in-process checks (LOD, particle size, etc.) and implement corrective actions. Report any deviations, equipment breakdowns, or abnormalities promptly. Follow safety, EHS, and cGMP guidelines strictly during operations. Preferred candidate profile Hands-on experience in RMG, FBD, Multi Mill, and Blender operations. Knowledge of granulation process parameters and troubleshooting. Understanding of cGMP, GDP, and regulatory guidelines. Good documentation and communication skills. Ability to work in a team and meet production timelines.

Role & responsibilities Plan, execute, and review Validation Protocols and Reports (Process, Cleaning, Analytical Method, and Computer System Validation). Execute and review Equipment Qualification activities (IQ/OQ/PQ, Re-qualification). Support preparation and maintenance of Validation Master Plan (VMP) . Ensure compliance with cGMP, FDA, MHRA, WHO, and other international regulatory guidelines. Coordinate with cross-functional teams (Production, Engineering, QC, R&D) for smooth execution of validation activities. Conduct risk assessments and gap analysis for equipment, utilities, and processes. Review and maintain SOPs, protocols, and technical documentation related to validation. Handle deviations, CAPA, and change controls related to validation/qualification. Participate in internal and external audits, providing necessary validation and qualification documents. Ensure timely execution of periodic re-validation and re-qualification activities . Preferred candidate profile Strong knowledge of cGMP, ICH, FDA, and other regulatory guidelines . Hands-on experience in equipment qualification (IQ/OQ/PQ) . Good understanding of cleaning validation, process validation, and computerized system validation . Strong documentation and technical writing skills. Excellent analytical, problem-solving, and communication skills. Ability to work collaboratively in cross-functional teams.