1. Ensure the Compliance to laid standards of the current Good Manufacturing Practices.2. Planning, Execution and Implementation in Warehouse.3. Responsible for handling of deviations, incident, change control and preparation of SOPs & maintain GMP documents.4. Supervise warehouse employees and oversee daily operations5. Investigation of Deviation at shop floor for identification of RCA & CAPA.6. To co-ordinate for calibration/preventive maintenance for all equipment and instruments with engineering/QA & outside agencies.7. Conduct all types of GMP training8. Check the availability of Raw material and Packing material for Production Planning.9. Responsible for good organization and communication/team management skill.10. Dispensing of RM PM as per SOP.11. Manpower handling and utilization of manpower in working areas of Warehouse.12. Responsible to supervise and perform receipt of raw materials and packing materials as per procedure.13. Monitoring the temperature, RH and differential pressure of Warehouse Department.14. Handling rejection return to vendor and destruction of reject and expired material.15. Responsible for all in-process checks during movement and storage of materials.16. Responsible for all entries regarding activity in respective software.17. Responsible to handle other works assign by the superior.

Job descriptionHaving technical knowledge/ experience in dossier compilation (CTD ACTD) for European, CIS, ASEAN countries.Awareness of regulatory guidelines (EU) & Pharmacopoeia. Controlling the whole process of registration product from beginning till the end.Evaluation of Bioequivalence.Having knowledge of ICH guideline.To be flexible for travelling and meeting with manufacturing plant representatives, which located out station (if required)?Must have excellent communication skillsMust have excellent in analyzing skillsExcellent in accuracy and focusSelf-motivated and enthusiasticRoles and ResponsibilitiesDossier Compilation & Review of both Finished Product and API (CTD, eCTD, ACTD) and reply of Subsequent Queries Independently.Maintained & update the regulatory documents /records. Follow up from plant R&D Team for AMD, AMV, Tech Transfer, Stability Charging Date, AMV timelinePreparation of all technical document of dossier like package inserts, rationale, drug-drug interaction.Review of artwork for submission.Prepare CTD, ACTD Dossiers and file regulatory submissions.Perform assessments of new or revised products.Manage complaint documentation (including investigation and closure).Respond to inquiries from regulatory bodies.Should be technically well versed with requirements for medicines with fare knowledge about medicines, food supplement.To coordinate with relevant department for arranging documents.To prepare / compile dossier for allocated products / countries.To coordinate with courier agency for dispatches of dossier /samples.To make timely entries of submissions / dispatches.Excellent communication skills.Should be aware about Microsoft office [word / Excel/ PPT] - Good in data management.Should be well versed in the process of Contract Drafting.Hands on experience and knowledge for drafting Non-Disclosure Agreements.Help the company for resolve the regulatory matters.

1. Responsible for all day to day operations In- process Quality Assurance activity.2. Responsible for IPQA activity in Dispensing, Manufacturing, Packaging and Dispatch stage.3. Check and ensure that area/ equipment are visually cleaned.4. Ensure the area is free from previous product, unwanted material and rejected labeled/container.5. Ensure the availability of BMR/BPR filled up to stage.6. Responsible for sample collection in manufacturing area and packing area at required stage.7. Preparation of Sampling plan and execution of process validation batch.8. Checking packing material requisition slip before dispensing of material.9. Follow the standard operating procedure applicable to the functions.10. Actively participate in the training activities and documentation.

To ensure the implementation of cGMP by the help of Standard Operating Procedures, Standard Test Procedures, Specifications, Validation protocols, Stability protocols, Master Batch Production records etc.Approval of SOPs, Protocols, Formats, reports and other GMP documents for all functions viz. QA, QC, Maintenance and Engineering, Production, and Warehouse.To implement good documentation practices.To release the finished products and to ensure the completeness of batch manufacturing and packaging records.Market complaint investigation in accordance with company guidelines and external regulatory requirements.To ensure appropriate disposition of incidents / OOS / OOT and approval of deviations.Review and approval of the Validation Master Plan, Site Master File, Annual Product Quality Review, annual planners and other documents related to QAD.To develop, implement, and manage processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.To ensure the handling of non-conformity as per defined procedure.To approve and maintain the artworks and shade cards.To ensure the handling of quality management system as per defined procedure.To ensure the thorough investigation of deviations and conclusion in accordance with cGMP. Review deviation reports and ensure that corrective and preventive actions (CAPA) are implemented satisfactorily.To ensure that all necessary documentation is completed accurately, in a timely manner, and in compliance with regulatory requirements.To conduct regular internal audits and planning of self-inspections of the manufacturing facility to ensure that the facility meets the required quality standards. Also handle the external audit and its compliance.To ensure that products are released only after they have met the required specifications and are deemed safe and effective.To approve aseptic process simulation study protocol and report.To approve all qualification / re-qualification protocols and reports.Involved in qualification process of new manufacturer / supplier / vendor meant for raw material, primary packing material or secondary packing material.To assign responsibilities and tasks to the assigned persons as per their qualification, experience and competency.

1. Handling of quality management system (Change Control system, Deviation, Incident & other related documents).2. To follow and implement good documentation practices.3. To prepare the Validation Master Plan, Site Master File and other documents related to QAD.4. To prepare and review validation protocols, execution of the activity and reports summarization.5. Preparation & implementation of SOPs related to the QAD.6. To investigate market complaints and to maintain market complaints investigation records.7. To issue, control, review and retrieval of Formats, Log books, Batch records & Protocols etc.8. To verify dispensing of materials and In-process quality control, online entries in BMR & BPR of product at manufacturing site.9. To give line clearance before starting of the activity related to batch.10. To ensure the handling of non-conformity as per defined procedure.11. To plan the internal audits and self-inspections of the manufacturing facility to ensure that the facility meets the required quality standards as per the procedure.12. To prepare and review qualification / re-qualification protocols and reports.13. To review the artworks and shade cards.14. To execute documentation as per procedure for approval of new manufacturer / supplier / vendor meant for raw material, primary packing material or secondary packing material.15. To obey any task assigned by reporting manager.

Analysis and review of raw materials, packaging materials, in-process samples, stability samples, finished goods, analytical method validation and analytical method verification. Calibration of equipments / instruments as per the planner.Review, preparation and maintenance of documents of raw materials, packaging materials, in- process samples, finished goods, stability and AMV samples as per the statutory requirements.Effective implementation of practices like GLP in QC Department.To prepare SOP’s and training outlines.Sampling of raw material and packaging material timely.To prepare and maintain the working standards & documentation.To maintain and control inventory of reagents, chemicals /glass wares, plastic wares & spare of other instrument.Reporting of Change Control, OOS, OOT, Incident, and Deviation as per requirement.Prepares and review of analytical reports and certificates of analysis.To perform analyst qualification.To ensure data integrity.Analysis & reporting of process validation samples, customer complaint and investigational samples.Preparation and standardization of volumetric solutions.Good communication skills demonstrated within team.

To provide analytical support to the concern department.Releases / Rejection of all raw materials / Packaging material / In-process samples and other samples as per statuary requirement.To organize the availability of resources.Effective implementation of GLP in Quality Control Department.Ensure the updation of Master Specification for RM/PM/FG/SFG/In-process.Ensure the sampling of incoming Raw materials, Packaging materials and Microbiological sampling as per current SOPs.Ensure that the testing of Raw materials, Packaging materials, In-process samples, finished good samples and other samples as per STP.Ensure the calibration of Instruments is completed as per SOP.Ensure the analysis of Rinse (wash water) and swab samples as per plan.Ensuring of documents of Raw Materials, Packaging Materials, In-process samples and Finished Goods as per the statutory requirements.Ensure that all training activities are completed as per SOP.To provide training to the new joiners in QC and other employees.To organize the preparation, maintenance of reference standard & working Standards and documentation as per SOP.To ensure sampling, analysis, and reporting of raw materials, packing materials, finished products, intermediates, in-process, stability, water and routine analysis as per current version of documents. To ensure availability of working standard and ensure the qualification.To ensure Analytical Method Validation and Analytical Method Verification.To ensure availability of current specifications in the laboratory and all the obsolete versions shall be sent back to QA for retrieval.To ensure analyst qualification.To ensure audit trail review in the system.Timely submission of analytical data to QA for the further release of batches.To ensure data integrity throughout the whole process of analysis and reporting.To ensure availability of adequate media, reagents and other necessary requirements for lab and their timely procurement.To ensure the record microbiologist test results in template and verification of the data before its release.To ensure the disposal of tested samples and used media for analysis.To ensure to ensure the environment monitoring of the area (including production area) exposed directly to the product as per their defined frequency and reporting the results.Ensure documentation of preparation and sterilization of media.To ensure that there are personnel with appropriate training and experience in microbiology and knowledge of the process to support the design of the manufacturing process, environmental monitoring regime and any investigation assess the impact of microbiological linked events to the safety of products Review and verify the documentation of OOS, OOT, Laboratory Incident, Deviation, and Change Controls for finished goods, raw materials, In-process, stability, packaging and other materials.Co-ordination with Internal and External agencies for technical support.Ensure the Preparation and Standardization of volumetric solutions / Working Standard is completed on time.To ensure effective implementation of the Quality Management System (QMS) in Quality Control Department with respect to laid down procedures and systems.To ensure that the critical equipments used for analysis are qualified and in calibrated status.To carry out self-inspections and ensure compliance to the audit observation.To ensure the compliance to the current Regulatory requirements and Guidelines. Any other work will be assigned to him as per need.