Role & responsibilities Physical checking of RM/PM Material with verification documents & labelling.To check the material is Received from Approved Vendors.Arrangement of Materials at proper designated areas.To Prepare GRN in SAP for Received of incoming material.To intimate Q.C. Department for Material sampling and after that the materials to be shifted on approved or rejected area.Material requirement Received from Production Department & Issue as per that, also issued material weight verify as per issued requirement.To maintain Physical Stock of RM/PM.To maintain all log books.To maintain Cleaning Record & supervision of all dispensing location with logbooksTo prepare stock valuation every month.Corresponding with Head office.Maintain narcotics, MA-I, RS-II stock & record.GRN for Received of RM/PM in SAPCo-ordinate with Production, Purchase, QA-QC and Other Department.To Raise Purchase Requisition as per Production planning and to ensure availability of material on time.Co-ordinate with cross functional teams & purchase as well with management for smooth operationsMaterial receiving, warehousing, distribution and maintenance operations.Ensure that the store is kept clean and organizedTo maintain of SOP trainings, CAPA, Deviation and Change Control.To maintain standards of health, hygiene, safety and security.To maintain stock control and reconcile with SAP.

Roles and Responsibilities Responsible for Analytical Method Validation.Responsible for HPLC/GC instrument handling.Responsible for Daily review of Analytical balance and Daily Temperature monitoring.Responsible to follow analytical procedures and generate online raw data.Responsible for Stability Studies and Analysis.Responsible to operate and analyze of raw materials, In Process, cleaning samples, samples for vendor qualification, Stability samples, standard and Finish product Samples and instrumental method (HPLC / UPLC / GC) and to perform analysis of process validation.Responsible for Daily verification of analytical balance and daily temperature monitoring. Online entry in logbooks of instrument, column, working standard, chemical inventory whenever use.Responsible for in process data review in night shift.Finished product sample receive, entry taken in register and maintain daily status.Responsible to follow all the Standard operating procedures, to give Instructions for housekeeping, cleaning and maintaining the laboratory area.Responsible to follow all the analytical procedures and generates online raw data, Chromatograms, calculation sheets and charts with reviewer signature.Responsible to control and maintain records like protocols, Specification, Standard test procedure, Analytical work record, Standard operation procedure, In- process analysis records, usage log books and status labels during day to day Analysis.Responsible to perform calibration and maintain its records.Responsible to Prepare and maintain record of finished product.Responsible to maintain record of chemicals, glass wares and other lab items of department.Responsible for cleaning, maintenance, and daily calibration of specified instruments.Responsible to maintain records and qualification of primary standards, reference standards and working standards.Responsible for reporting to senior if any abnormality observed during analysis and perform for the out of specification and to investigate the OOS (Out of specification) or OOT (Out of trend)if found and Responsible for maintaining QMS related documents.Responsible to follow various EHS (Environment Health and safety) guideline and use appropriate PPEs (Personal protective equipments). .Desired Candidate Profile Candidate Should be from Pharma backgroundCandidate Should have excellent knowledge of ICH GuidelinesPrefer Who can work in a shift and willing to relocate in Navsari, GujaratCandidate should have Work Accuracy.

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 CommunicationWilling to Relocate in Navsari, Gujarat,Willing to Work in a Shift.

Role & responsibilities Job Description/Responsibility for 5-7 Years Experience candidate (Designation: Sr. Research Executive-SRE)Candidate must have throughout experience in Peptide process developmentMust be familiar with the designing of peptide drug substances route of synthesis Sound knowledge about the capping/cyclization of peptide chainKnowledge about protection and Deprotection of amino acidsKnowledge about global deprotection of peptide form Peptidyl resinMust be familiar about the isolation of crude peptide Knowledge about the critical process parameters of solid phase Peptide synthesis Basic knowledge about purification techniques for crude Peptide9.Able to handle 100 mm DAC as on requiredMust be familiar with peptide synthesis process scale upJob Description/Responsibility for 2-3 Years Experience candidate (Designation: Sr. Research Associate-SRA or Research Executive-RE)Candidate must have experience in Peptide process developmentAble to perform experiment as suggested by team leaderKnowledge about protection and Deprotection of amino acidsKnowledge about global deprotection of peptide form Peptidyl resinMust be familiar about the isolation of crude peptide Knowledge about the critical process parameters of solid phase Peptide synthesis Basic knowledge about purification techniques for crude PeptideJob Description/Responsibility for– 2-4 Years Experience candidate (Designation: Sr. Research Associate-SRA or Research Executive-RE)Responsible for Column packing and un-packing activity for purification trialsResponsible for Column Performance Test (CPT)Peptide & API Purification method development on preparative HPLC Perform downstream-Purification of Crude Peptide on 100 mm DACDefine pooling strategy/control strategy for Purification methodPreform salt exchange activity on 100 mm DACGenerate report for Design of Experiment (DoE) for Purification Co-work for solid phase up-stream synthesisPerform and optimization of global deprotection of Peptidyl resin

The Manager Human Resource is responsible for Recruitment, employee induction and on boarding, PMS, HR Systems, Change Management, Talent Management, employee engagement and site culture management. Essential Duties and Responsibilities:New joinee Induction and onboarding: To fill all open position in defined time lines.To ensure all positions have attractive job descriptions.To provide exceptional onboarding experience to new joinees.Seek feedback after one month and six months from new joinees and initiate corrective action, if needed.HR Systems: Ensure HR systems - HRMS are efficiently used to reduce / eliminate human interference. Ensure employees use these systems optimally to invest time productively.Talent Management, Succession planning and leadership development: Develop and implement succession planning process at site.Identify potential successor for key positions and people.Identify and develop high potentials Take appropriate steps to retain and develop them for higher roles. Performance Management: To ensure all positions have job descriptions.To roll out PMS effectively to create a performance driven work culture that is based on merit, talent, performance and adherence to company vision and values. Training and Development: Identify behavioral training needs of individual employees and organization as a whole.Organize appropriate trainings/ workshops.Organizational Culture: Develop performance oriented agile workforce that initiates, embraces change in line with fast changing business environment. Develop work culture of merit, understanding,

QC Manager/ Sr. Manager Job ResponsibilitiesTraining to staff for following practices as per standard operating procedure, Good Laboratory Practices and Pharmacopoeia / in-house method of analysisTo monitor data integrity in Compliance of good laboratory practice and Compliance of GMP in the Quality Control Laboratory.To check and sign Certificate of Analysis (COA) for export as well as domestic.To review and ensure Deviation, Corrective action Preventive action (CAPA) report, Market Complain Investigation related activity and its implementation.To review risk assessment and appropriate measures to mitigate the risk and to prevent reoccurrence of risk.Ensuring effectiveness and applicability of the QA system through self-inspection and Quality audit.Improvements / revision in Standard operating procedures as per procedure and their implementation from time to time.To monitor retain samples/logs and physical observation as per standard operating procedure.To monitor stability samples, test frequency and summary results.Monitoring of necessary testing being carried out timely as per specifications and method of analysis and release of certificate of analysis.To monitor maintenance/ repairing of instruments and their annual maintenance contract from external agencies.Co-ordination with public testing labs for timely test report. Getting technical agreement with them, pay visit at time of test to monitor correct method of analysis, whenever necessary.Interdepartmental co-ordination for smooth working to reduce down time in mfg. & packing of various products.To manage for incidents for all testing related chemicals/ apparatus/ standards/ media/ accessory/ parts/ books/ stationary/ dress/ men power requirement, new machine requirement. etc, for timely testing for API/ excipients/ In-process/ finished products/ stability samples etc.Supervision, guidance and inspiration to down the line colleagues for improvement of systems with respect to quality/ data integrity/ efficiency/ correct work procedure etc.To investigate Out of Specification/Out of trend and take appropriate corrective action and preventive action as per standard operating procedure.To prepare risk analysis documents and monitor for probable risks in testing/ reporting, train staff accordingly.Active participation in technology transfer and validation exercise.Evaluation and monitoring of trend data.Monitoring soft data management.To Review and Approved Finish Product (Injection/API), Raw material, Packing material Specification, Standard Operating Procedure, Analytical Work record.To release and approved Raw material / Packing Material in SAP system along with Certificate of analysis (COA).To approved Certificate of analysis (COA) and Release the Semi-finished & Finish product in SAP system. (i.e. I1 and A1)To conduct internal audit / External Audit / self-inspection to ensure compliance to GMP and other regulatory

Role & responsibilities Responsible for defining QA strategy, approach and execution in the field of document control, IPQA, qualification/validation, GLP, training activities etc. and responsible for leading and directing QA teamTo approve SMF, VMP, quality manual and validation protocol.To conduct internal audit / self-inspection to ensure compliance to GMP and another regulatory requirement.To arrange management review meeting and escalate the outcome of quarterly report to management.To handle the Market Complaints and to participate in Product Recall.To approve quality system documents likes Change controls proposals, Deviations, Incident reports, CAPA reports, OOS and OOT, NCR, Market Complaints, product recalls and Returned goods.Responsible for review and approval of new as well as revised related Specification, Standard Test Procedure and Analytical Work Record.Responsible to design validation/ qualification strategiesResponsible for validation /qualification of processing equipments, cleaning equipments and testing equipments on time.Responsible for day-to-day validation planning and execution activity.Responsible to approve specifications, standard test procedures and analytical work records. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports.Responsible for regulatory & customer audits preparation, execution and its compliance.To approve and authorize technical agreements from customer and outside party. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department.Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing.To ensure the implementation of quality risk management procedures.Responsible to finalize training topics as per requirement and organize annual training plan with Training coordinator on cGMP and technical aspects.To ensure that processes needed for the Quality Management System are established, implemented and maintained.Responsible for investigation & review of non-conforming events including customer complaints and internal non-conforming events.Responsible for report, review, evaluation and tracking of change control, deviation, incident, market complaint, non-conformance report, product recall, corrective and preventive action.Responsible to ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of Quality Management System.Responsible to perform vendor audits and internal audits.To check audit trial and back-up verification documents.Participation in study raised through Quality Management System.