RESPONSIBILITIESCoordination with the customer to compile the dossier as per current registration regulations in SEA & East Africa markets.Coordination with the customer at various registration stages to obtain approval.Analyze the molecule and determination for need of Bioequivalence or bio waiver studies.Life cycle management of product license by filing renewals and analyzing the type of variation needed to be based on the proposed changes to DMF, formulation, packaging, or excipients.Review and approve the artworks as per Brazil and Canada market regulations.Interpretate deficiencies received compile and submission responses within the stipulated time frame.Maintenance of tracker for submission and deadline for responses and coordination with stakeholders to submit responses within stipulated deadlines. DESIRED SKILLSGood knowledge of Registration requirements in ROW market.Experience in submission of generic medicine dossiers to the ROW market.Good technical knowledge, review skills and understanding of regulatory submissionsStrong knowledge of CTD/ ACTD requirements for submission of dossiers to SEA , ME & AFRICA markets.Good analytical and problem-solving skills.Ability to try new approaches when faced with challenges.Should have a good analytical and learning attitude.Proactive to submission of response to any queries.Good communication skills.

Job descriptionRESPONSIBILITIESEnsure that quality control laboratory is ready all time for any regulatory inspection. To ensure this by continuous monitoring of GLP practices.Co-ordinate for internal & external calibrations of QC instruments.Ensure analyst validations are as per the SOP.Co-ordinate with service providers for breakdown and preventive maintenance of instruments.Calibration of QC instruments as per defined schedule.Analysis of finished products and raw material samples.Perform analytical method verification / validation of finished product samples.Prepare working standards. Reference & working standard issuance / discard / maintenance (reconciliations, procurement, and validity check of reference standards).Ensure compliance to good documentation practices & good laboratory practices.Comply and ensure the implementation of safety practices. WORK RELATIONSInterfaces: InternalQuality Assurance, Quality Control, EHS, HRA, Warehouse, EngineeringInterfaces: ExternalExternal Vendors.DESIRED SKILLSMust have experience in Quality Control department in reputed pharma organizations.Should have hands on experience of Instrument HandlingStrong knowledge of operating HPLC, GC, KF, IR, pH Meter etc.One Should Manage day to day PlanningOne should Timely review of logbook entries & daily monitoring activities.

RESPONSIBILITIES Preparation and review of master batch records / batch manufacturing records, qualification documents (URS, DQ, IQ, OQ, PQ, volumetric calibration, surface area calculation etc.) & QMS documents.Preparation and review of standard operating procedure.Preparation and review of organogram, job responsibility, training needs & list of list. Preparation and review of training matrix & training plan.To ensure online documentation related to all CGMP activities including data integrity.Initiate, review & complete required change control, deviations, investigations & CAPA impact.Reviewing & maintaining all logbooks in the manufacturing area and plant. Operation of primary and secondary water treatment plant as per standard operating procedure and look after operations in solvent recovery plant.Responsible for performing validation & qualification activities in the plant (equipment qualification, process validation, cleaning validation).Responsible for the execution of validation & scale up batches for all the products to be manufactured.Proper utilization of available manpower (no contract people) & manufacturing facilities to enhance productivity.Ensuring timely manufacturing schedule as per production planning & maintaining quality & safety parameters. DESIRED SKILLS Must have experience in API production in reputed pharma organizations. Should have hands on experience of Manpower Handling Strong knowledge of operating DCS (Distributed Control System)One Should Manage Shift PlanningHandling of Water System OperationHandling of Process Equipments like Reactor, Centrifuge, RCVD, RVPD, FBD, Bin Blender, Co-mill, etcGood Knowledge of preparing BMR and BPR.Should have sound knowledge of drafting and reviewing of SOP’s.Good Communication and problem solving skills. Should be assertive, proactive, and self-driven.Ability to work in dynamic environment.

RESPONSIBILITIES Responsible for review of In process, Raw materials, Intermediates, Recovered materials, Finished products, Tech transfer samples and Cleaning verification / validation samples using current Specification, STP,GTP and associated wet chemistry and instrumental techniques as appropriate.Prepare and review specifications, sampling instructions, test methods, analytical work records and other QC procedures.Responsible for review of instrumental analysis as per the Matrix of analyst / microbiologist validation.Preparation and review of training matrix & training plan.Prepare and review cleaning validation / verification, Method validation, Method verification, Method transfer protocols and reports.Prepare and review study protocol and report for Quality control activitiesPreparation & review various quality documents such as SOPs, validation protocols and reports. Responsible for review of calibration of QC instruments like HPLC, Analytical Balance, Ultra Micro Balance, pH meter, Conductivity meter, UV spectrophotometer and refractometer etcResponsible for preparation, review, tracking of yearly calibration schedule, monthly calibration planner & preventive maintenance schedule.Ensure the tracking and follow up for the Method Validation, Verification & Analytical Method Transfer Activity.Planning and Execution of Method Validation, Verification & Analytical Method Coordinate with service engineer during preventive maintenance and breakdown of QC instruments.Responsible for verification of Laboratory chemicals, Reagents and Indicators.Review of logbooks in Quality Control Department and Responsible for monthly audit trial review for instrument.WORK RELATIONS Interfaces: InternalQuality Assurance, Quality Control, EHS, HRA, Warehouse, Engineering Interfaces: ExternalExternal Vendors.DESIRED SKILLS Must have experience in Quality Control department in reputed pharma organizations. Should have hands on experience of Instrument Handling Strong knowledge of operating HPLC, GC, KF, IR, pH Meter etc.One Should Manage day to day PlanningShould review method validation, Verification & Analytical Method Transfer Activity.One should timely review of calibration / verification of instruments.Ensure timely review preventive maintenance of instruments.Should review of records of QC testing.One should Timely review of logbook entries & daily monitoring activities.

RESPONSIBILITIESCompilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU, UK and AUS-NZ. Publishing in eCTD format and submission to respective Regulatory Agencies.Compilation and submission of variation applications for EU, UK and AUS-NZ.Review of documents related to compilation of dossiers and query responses.Up to date knowledge of regulatory guidelines and requirements. DESIRED SKILLSMust have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycleShould have handled initial MAA submission & Variations for EU.Good technical knowledge, review skills and understanding of regulatory submissionsStrong knowledge of CTD /eCTD requirements for modules 2 and 3 is mandatory.Hands on experience with compilation of module 1 and portal submissions would be preferable.Ability to try new approaches when faced with challenges.Should have good analytical and learning attitude.Good communication (written and oral) and inter-personal skills.