Manager
Job Description
• Planning and Execution of all MMD-I & BPR preparation activity pertaining to Main Pharma Block, Cephalosporin Block, Penicillin Block & Rifampicin Block of Dholka, as well as Contract Manufacturing & Herbal.
• Preparation and review of MMD-I & BPR of
• Main Pharma Block
• Cephalosporin Block
• Penicillin Block
• Rifampicin Block
• Contract Manufacturing
• Herbal
• Initiate and review of change control, deviation & CAPA.
• Preparation of SOP pertaining to functioning of the department.
• Preparation of MMD-I & BPR of ANDA market.
• Intra as well as inter department co-ordination with respect to preparation, review & approval of MMD-I & BPR.
• To create ZFRT codes for Export market (Dholka, Jammu & Jammu2) in Master Data Management (MDM).
• To create ZHLB code for Export & Domestic market (Dholka, Jammu & Jammu2) in Master Data Management (MDM).
• To create & update BOM of ZHLB & ZFRT codes for Export & Domestic market in Master Data Management (MDM).
• To co-ordinate with Production, SCM, QC, RA, Tax, Purchase, Finance & IT departments for SAP/MDM related issue.
• Any other jobs assigned by Head QA.
• Validation of computerized system as per regulatory requirement
• Data integrity of computerized system
• Prepare/Review/Revise SOPs related to computerized system validation.
• Prepare/Review/Revise master validation plan for computerized system validation.
• Prepare/Review/Approve validation deliverable related to CSV.
• Periodic review of all GxP computerized system.
• Monitoring User Account Management of GxP System.
• Monitoring Data Backup, Archival and Restoration of GxP System.
• Monitoring Inventory Management of GxP System.
• Monitoring Information security Policy of GxP Systems.
• Monitoring of PLC and Spreadsheet validation activity.
• Monitoring activity related to IT SOPs.
• To participate in Internal (Self inspection) and External audits.
• To assist for any other assigned jobs from time to time.
• To conduct the self-Inspection/ Date Integrity inspection of different departments.
• Retain sample management and executed batch document
• To ensure terminal Inspection of finished goods for export market dispatched from Dholka.
• Responsible for Terminal Inspection of finished goods for export market dispatched from Dholka.
• Responsible for terminal inspection of all LL products.
• Responsible for sampling of all LL products for QC testing and retain sampling for LL Products.
• Responsible for Retain sample management for MPB, Rifampicin, Herbal, and LL Products.
• Responsible for executed BMR management.
• Responsible to prepare Certificates of Conformance, Declaration and Approval letters as per requirement.
• Responsible for timely perform periodical observed of retain sample.
• Responsible to send BMR/BPR as per requirement of country wherever required.
• Any job assigned time to time by seniors.
• To look after smooth and proper functioning of the assigned job responsibilities.
• To ensure for proper handling, issuance, retrieval, distribution and archival of quality documents, SOPs etc.
• To ensure the PQR is prepared, reviewed and approved within the stipulated timelines.
• To ensure cGMP related training program for all concerned manpower.
• Responsible for assigning appropriate job responsibility to subordinate and train them for completion of activity in compliance with cGMP.
• To assign JOB role/ TNI of subordinates in TIMS.
• To generate final completion certificate for new joiners after completion of their training.
• To review Change Control, Deviations and CAPA in LIMS.
• Any other jobs assigned by Head QA.
• Responsible for review, tracking and closing of deviation, change control and CAPA in LIMS.
• Responsible for participating in investigation along with cross functional team to find out actual root cause of incident or deviation.
• Responsible for review and assign number to Deviation, Change control, CAPA when required supporting documents is available in system.
• To ensure the completion, closing and effectiveness of CAPA given to the different regulatory and customer audit.
• Responsible to take follow up with cross functional team to approval & closing of deviation, change control, CAPA.
• To check the effectiveness of implemented change control and CAPA as required.
• Responsible for review of manufacturing investigation.
• Responsible for handling of Market complaints. Perform investigation and report preparation.
• Responsible for review of manufacturing investigation.
• Responsible for preparation and review of Risk assessment.
• Responsible for logging of conversion note.
• Responsible for preparation of Trend analysis report for QMS records as per SOP.
• Responsible for review change control, deviation and CAPA logs from system.
• Responsible for handling of recall procedures.
• To prepare and revise the departmental SOP and ensure training to all concerns.
• To perform mock recall and documented all the activity within timeline as mention in the schedule.
• To assist for any other jobs assigned from time to time.
• Responsible for FAR handling and sharing investigation report for register market complaints.
• To Perform Vendor Audits for Vendor Qualification as per requirement of RM/PM.
• Perform effective self-inspection as per schedule and ensure timely closing with proper CAPA or justification for the noncompliance found during self-inspection.
• To participate in all internal and external audits.
• To prepare compliance report of different customer and regulatory audits.
• To make sure that internal and external audit compliance report is prepared within given timeline.