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Deputy Manager Job in Cadila Pharmaceuticals Ltd at Dholka

featured-job FEATURED JOB

Deputy Manager

Cadila Pharmaceuticals Ltd
experience-icon 0 Years
salary-icon Not disclosed
location-icon Dholka
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Posted: 23 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. • 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 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. To perform the in process checks for control on production for the process / product being manufactured. To ensure Quality and cGMP compliance of the products being manufactured. Parenteral Manufacturing : •To give Area /Equipment clearance i.e. checking and approval of all manufacturing & filling. To verify environmental condition i.e. Temperature, Relative Humidity & Pressure Differential condition in all for said areas are within acceptable range at all the time during operation throughout the shift. To ensure daily verification of weighing balance with standard weights. To ensure sterilization cycles completion as per loading pattern & SOP. To ensure lyophilization cycles completion as per MMD-I & SOP. •To perform filled volume & weight method and leak test as per MMD-I & SOP. •To perform sampling of bulk and finished product for each batch at the end of the batch as per SOP entry into sampling log and submit the samples to QC for analysis. •To review the Batch Manufacturing Records for on line entries at each stage. To review sequential log of machines. To review environmental condition records. To review of area cleaning logs. •To release the batches for further processing. • To review and checking Batch Manufacturing Records for reconciliation, correct entries, completeness, affixing of release status labels. •Reporting to shift in charge to address the observations under Deviations, unusual observation Daily report of total activities performed Parenteral Packing : •To give line clearance i.e. checks and approval of all packing. •To perform checking and approval of overprinting details on printed packing material like blisters, cartons, labels etc. As per Batch Packing record. •To verify the correctness of primary and secondary packing materials of product being packed as per CMOF and MMD-II. •To perform periodic checks of overprinting details, number of units per pack, absence of empty pocket etc. •To perform spot-checking on inspected ampoules/ vials SOP. •To verify challenge test for brevity inspection machine. •To review the Batch Packing Records for on line entries at packing stage. To review sequential log of machines. To review of area cleaning logs. •To co-ordinate with packing supervisor in relation to the issue related to packing. •Any job assigned time to time. Intermediate & final Release of Finished Product in SAP

Job Particulars

Education Any Graduate
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id2928928
Locality Address
Country India

About Company

Cadila Pharmaceuticals Ltd
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