Rhydburg

Dehradun, Uttarakhand

Evaluate market complaint and initiate investigation. Identification of route cause (RCA).Investigate & Review OOS/OOT/CAPA .Review and ensure compliance for CAPA for both internal and external audits.To issue deviation & ensure, CAPA & RCA analysis for deviation.To provide RPN Numbers to Risk & plan CAPA as per RPN numbers as per SOP.Periodic Post Approval Review of Vendors (RM & PM) Issuance of STOP Sale Letters based on Stability Reports or Market ComplaintsPerform periodic mock recall inline with SOPIssuance of Response of Market Complaint to regulators / complainantReview of Finished Product SpecificationsCompilation of Data for Skip Testing

Responsible for the execution of Production plan and managing the use of man power for multiple shifts, coordination between various departments.Ensuring timely up keep and preventive maintenance compliance of all equipments.Monitor and manage staff to meet deadlines and commitments. Prioritize, direct and oversee work activities and schedules and communicates with cross functional teams to ensure adherence to objectives and goals.Ensures adherence to cGMP's, standard operating procedures, safety practices Ensures the safety of all through compliance with all company policies, procedures, safety rules, and regulations.Participates in external and internal audits and inspections. Appraise the management on departments performance and self-evaluate on key responsibility area. Proactively responds to audit observations and takes appropriate corrective actions.Responsible for ensuring that training and development systems of control are in place to meet future objectives of the business.Ensure quality standards and processes are used throughout manufacturing. Work constantly with Quality Assurance on continuous improvements and provide preventative and correction actions when problems occur.Supervise, regulate and manage operations of raw and packing material stores.Assist, and review Root Cause of general problems arising on day-to-day basis.Handling Visitors and Auditors, in coordination with QA for those coming to Manufacturing area.Monitoring all activities related to stores - Raw Material and Packing Material.Review Audit Reports and its compliance.

Ensure & verify the all received material on material receiving bay. Ensure the all calibration & verifications activity of weight balance as per sop. Review & Verify the all preventive maintenance of sampling booth & dispensing booth. Ensure the all Vendor approval as per their records. Review & verify the all document such as environment monitoring records, log books, calibration records, dispensing records.Ensure line clearance at the time of material sampling & dispensing. Ensure cleanliness and upkeep of storage racks, equipment, dispensing utensils, sampling utensils. Verify the all materials are labeled and stacked in an orderly.Ensure material is stored in right compartments in designated area. Verify material dispensing in record with BMPR and Requisition slip.

Understanding and implementing QMS and GMP concepts.Referring issues to senior Production staffPerforming day to day activities related to dispensing from stores and verification at different stagesResponding to other ad-hoc queries from other personnel in the company, after consultation with other production Staff.Performing supervision and manufacturing related activities at various stages.