Greetings From 3g hr services !!!! Role: Quality Control Manager Job Location: Medchal Qualification: BSc /B.Pharma/ MSc/M.Pharma Experience: 6+Years in the Pharma Industry Roles and Responsibilities: Allocated Tasks: - a. Daily / Regular - Forward all QC purchase requisitions to the Site Quality Manager and ensure that all the Chemicals and consumables are available in QC. - Review Analyst proficiency and requirements for qualification in new methods & training. - Lead the Lab during audits by Principals and Regulatory bodies. - Responsible for training the Lab chemists for the usage of the right specifications, test methods, and reports. - Responsible for timely release /Reject all Raw Material, Packing Material, Intermediates, bulk products, and FG Products. - Responsible for GLP to be maintained in the LAB. - Responsible for preparing the SOPs related to QC. - Responsible for review of AMC for all critical types of equipment in the Lab and follow up with Service engineers for necessary servicing and maintenance of all the types of equipment in the lab. - Responsible for review of batch records and analytical reports and submit to QA for final release. - Daily meeting with the chemists to review the previous day\'s v/s plan. - Responsible for reviewing and approving the change control, Deviation lab incidents OOT/OOS, etc. - Responsible for investigating the deviation OOT/OOS/Market Complaints. - Responsible for reviewing the analytical data and audit trails. - Review and Approve the Reference/ working standard data. - To review and approve analytical qualification data and approve the analyst. - Co-ordinate the external Lab/ Service personnel for analytical data/calibration data purposes. - Review the stability protocol and tracking sheet. - Responsible for reviewing the OOS/OOT and Investigation data. - Responsible for analytical method development and method transfer. b.Weekly : - Weekly meeting with the Site Quality Manager to update the status c.Monthly: - Review key performance and update the monthly scorecards/reports. - Update the data for the monthly meeting presentation. d.Annual - Provide the required Data for the preparation of the Annual product review. - Provide the data for the Mock recall exercise. - Calibration of equipment: Preparation of annual calibration plan for Lab equipment and make sure that lab should follow the same. -\xe2\x80\x98 Preparation of stability protocols for Commercial products, Trial products, or when any changes are executed in RM/PM (either in Master batch or Material /Container /Supplier process). -\xe2\x80\x98 Stability protocols for accelerated studies for new initiatives or existing products as & when there are changes due to the above reasons. e.Cost& Resource Control c. -Effective planning in the utilization of Lab chemists. d. -POP Report f.Quality& Systems.- - - Key support on validations on the site or any Trials for Raw Materials /Packing Materials /Formulation changes. - Use the right specifications, right methods, right equipment, and Qualified chemists in testing. - Is responsible for compliance with the following SOPs \xc3\x98 All QA SOP\xe2\x80\x99s \xc3\x98 All QC SOP\xe2\x80\x99s \xc3\x98 VVRM SOP\xe2\x80\x99s i.e.VVRM-001,010,012,017,018,020,023,027. \xc3\x98 VINM SOP\xe2\x80\x99s i.e. VINM-001,006. \xc3\x98 VVRP SOP\xe2\x80\x99s i.e. VVRP-009,010,011, 018,019. \xc3\x98 VINP SOP\xe2\x80\x99s i.e. VINP-001,004. \xc3\x98 WH SOP\xe2\x80\x99s i.e. WH-001,003,009,010,013,015,019,020. \xc3\x98 UTY SOP\xe2\x80\x99s i.e. UTY-019. \xc3\x98 ADM SOP\xe2\x80\x99s i.e. ADM-002 to 010,013,017,019,020. \xc3\x98 IODP SOP\xe2\x80\x99s i.e.IODP-003,009,011,017,020, 021. \xc3\x98 IODM SOP\xe2\x80\x99s i.e. 001,007,014,016,022,023. \xc3\x98 BRP SOP\xe2\x80\x99s i.e.001 to 004. Key Roles to be handled in the absence of the Superior Manager (Quality)Key Roles:

• Approve Deviations, Change Control, CAPA, and, Complaints.
• Approve Closure status on Plant Deviations/Exceptions
• Approve / Release or reject them, starting materials, packaging materials, intermediate, bulk, and finished products.
• Approve specifications, sampling instructions, test methods, and other Quality Control procedures
• Check the maintenance of the QC department, premises, and equipment.
• Review & approve reworks of RM/PM or FG if needed.

Key Roles to be handled in the absence of the Subordinate executive (QC)Packing Material Key Roles

• Forward all QC purchase requisitions to the Site Quality Manager and ensure that all the Chemicals and consumables are available in QC.
• Review Analyst proficiency and requirements for qualification in new methods & training.
• Lead the Lab during audits by Principals and Regulatory bodies.
• Analytical support (If required) for consumer and regulatory complaints.
• Responsible for collecting the stability data and forward to the Site Quality Manager for both accelerated and long-term stability samples.
• Responsible for training the Lab chemists for the usage of the right specifications, test methods, and reports.
• Responsible for timely release /Reject all Raw Material, Packing Material, Intermediates, bulk products, and FG Products.
• Responsible for GLP to be maintained in the LAB.
• Responsible for preparing the SOPs related to QC.
• Responsible for review of AMC for all critical Equipment in the Lab and follow up with Service engineers for necessary servicing and maintenance of all the equipment in the lab.
• Responsible for reviewing batch records and analytical reports and submit to Site Quality Manager for final

Chemist Key Roles

• Ensure that the required initial and continuing training and chemist qualification of QA/QC of the department personnel is carried out and adapted according to need.
• Monitoring of the activities of the in-process chemist and workload distribution to ensure online batch documentation.
• Daily meeting with chemists to review the previous day\'s v/s plan.
• Monitor reworks of RM/PM or FG when required.
• Monitor closure status on plant Deviations
• Monitor closure status on Complaints and change controls.

Updation on the deviations, change controls, and complaints to the in-process chemists Job Types: Full-time, Permanent, Fresher Pay: Up to 500,000.00 per year Schedule:

• Day shift
• Fixed shift
• Morning shift

Work Location: In person