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 current 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.

📌 Deputy Manager (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka