Farhan Gulab Shaikh

Responsible for compliance with all SOP’s and Operational manual issued by the client organization.  Resolution of service complaint, ensure proper documentation. Inanition’s to Client Company.  Ensuring infrastructure is well maintained-including but not limited to -A/C Temperature Monitoring equipment, Pest control etc. & report to CWH director and CWH Manager in case of any issue.  Ensure Validity of annual maintenance contracts.  Preparation of training matrix & responsible to conduct training on monthly basis to employee’s.  Liaising to Novartis H.O. for any issue/queries.  Approval controlling of all master & authorized documents.  Self-inspection & Audits.  To review temperature mapping & temperature monitoring report.  Verification of Indent.  Monitoring Cold chain packing.  Vendor Assessment.  Complaint Handling.  Deviation.  Change Control.  CAPA.  Incident Handling.  Verification of Finished Goods.  Safety Checks.  Support to other department.(Regulatory/ Complaint/NCQ team)

Preparation all cGMP/GWP documents inclusive of SOPs, Manuals related to Quality system as well as individual departments/operational activities of the company.  Implementation of quality assurance standards, processes, controls and cGMP throughout the facility.  To conduct vendor audits and internal audits.  To face global and external quality audits.  Ensuring adherence to training schedule and impart training to employees / Vendor on SOPs, GDP & GWP.  Preparation of the validation protocol and reports (areas, equipment).  Conducting Validation activity for all the equipment’s like cold rooms, deep freezers etc. and their AMC.  Preparation of investigation reports, deviation or incidence reports.  Handling change controls with its impact assessment.  Handling Deviations.  Handling of Quality audits, assessment of CAPA for audit observation and its follow-up.  Communicating with the QA personnel of principal companies.  To prepare compliance report for external audits with co-ordination with differentdepartments.  Perform root cause analysis with direct correlation to audit findings with focus to improvethe overall QMS.  Monitoring the calibration activity done by external vendors and review of calibration certificateof the same.  Monitoring all warehouses for quality compliance.  Responsible for documentation related to quality system guidelines.  Gather, analyses and manage quality related data and report on timely basis to Head QA.  Review of batch packing records (BPR).  In process quality checking (IPQC).  Reconciliation of batch after completion of repacking activity.  Preparation of batch packing records.  Monitoring repacking facility for quality compliance  Release of imported consignments by evaluating temperature data.  Handling issues for excursion during transit.  Handling destruction activity.

Sales and Marketing

Sales and Marketing