Senior Manager Job in Cadila Pharmaceuticals Ltd at Dholka
FEATURED JOBSenior Manager
Cadila Pharmaceuticals Ltd
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Posted: 22 Jul 26
Job Description
• 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.
• 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 of change controls related to Pack F&D, packaging materials, artworks and packing process in LIMS.
• Responsible for review and approval of MMD II in system.
• Carryout packaging material vendor qualification and vendor audit.
• Communication with packaging development, regulatory affairs and customer on artwork development and any new pack development for smoothly execution of work at shop floor.
• Involve in packaging material QC activities like specimen approvals.
• Advice on technical and other limitations related to artwork, advice on solution during artwork creations.
• To prepare and revise the departmental SOP and ensure its training.
• Take part in CFT meetings related to packaging materials issues
• Involve in investigation of market complaint relevant to packaging material quality
• To assist for fulfill of audit observations related to packaging materials.
• To assist for any other jobs assigned from time to time.
• Ensure the client approvals on any significant change in any MMD II.
• Quality improvisation of exiting pack without shacking existing costs.
• 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 perform vendor management activity to assure that vendors are complying with Cadila procedure on vendor management and GMP requirements in order to source quality materials and products.
• To perform self-inspection activity to assure that the facility remains in the state of cGMP compliance, to evaluate and identify gaps for future needs and to regularly review the effectiveness and applicability of the quality assurance system.
• Responsible to assist for handing of day to day activities related to Vendor Approval.
• To assist for evaluation of vendor documents and maintain current status.
• To assist for preparing vendor grading of RM/PM based on rejection of supply from vendors on yearly basis.
• To assist for providing required documents of vendor to cross functional team.
• To assist for transfer of RM/PM stock in SAP, due to on-line rejection.
• To assist for submission of the vendor samples to QC and maintain log of Sample Register.
• To assist for intimation of RM/PM rejection to purchase department for CAPA and maintenance of RM/PM rejection tracking Sheet.
• Responsible to assist for create & update of Raw Material & Packing Material vendors in SAP.
• To perform vendor audits for vendor qualification as per requirement of RM/PM.
• To maintain quality agreements with manufacturers and contract manufacturing parties.
• To prepare and review of Site Master File and Quality Manual.
• To prepare and review of excipients risk assessments.
• Handling of Quality Management system (QMS).
• To co-ordinate and perform the Self-inspection activity at the Site.
• To prepare auditors list for self-inspection activity and conduct training program for auditors.
• To prepare audit report, review compliance report, logbook updation, follow-up for the CAPA and to ensure effective implementation of CAPA.
• Preparation, Review, Issuance, Revision, Control and Retrieval of SOP pertaining to functioning of the department.
• To assist for any other jobs assigned from time to time by HOD.
• 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.
• Participation in GMP Audits (Audit Checklist Compilation, Compliance Report Preparation etc.), to co-ordinate the Self-inspection activity, Quality Risk Assessment, implementation of Serialization applicable to all manufacturing block, to investigate Market Complaints & Deviations with cross-functional team.
• To co-ordinate the GMP audits on the site, Audit Checklist execution, follow up for the CAPA, preparation of compliance report and to ensure the effective implementation of CAPA
• To co-ordinate the self-inspection activity, follow-up for the CAPA and to ensure effective implementation of CAPA.
• To conduct monthly Quality Review Meeting and follow-up the proposed CAPA for its effective implementation.
• Prepare and review of Quality Risk management related to equipment, process, utilities etc.
• Responsible for investigation to find the actual root cause of Market Complaints and Deviation along with cross-functional team and implementation of identified CAPA.
• Responsible for initiation, review, assign number, tracking of Deviation, Change Control and CAPA.
• Implementation of Serialization activity, conduct QA testing for integration of Client server and Cadila server for all part of world and provide necessary support for execution.
• Responsible for review and approval of Master Data of the client and product in VeriShield and Rfxcel.
• To perform the qualification & Validation activity of new as well as existing equipment’s, area, utilities and critical activities or processes and preparation, compilation and review of qualification and validation protocols & reports.
• Responsible for any other jobs assigned from time to time.
• 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.
Job Particulars
Role head quality
Education Any Graduate
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id2928361
Job Category Quality Control
Locality Address
State Gujarat
Country India
About Company
Cadila Pharmaceuticals Ltd
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