• 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.
