ManagerJobs Opening in Cadila Pharmaceuticals Ltd at Dholka
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.
Job Particulars
Education Any Graduate
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id2845450
Job Category Manufacturing
Locality Address
State Gujarat
Country India
About Company
Cadila Pharmaceuticals Ltd
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