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 recent 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 o

📌 Senior Manager (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka