Quality Control Manager

Kumar Organic Products; Dahej; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Kumar Organic Products in Dahej, Gujarat, seeks a Quality Control Management professional with pharma industry background to lead QC activities and ensure GMP compliance. You will coordinate analyses, handle investigations (OOT/OOS/ Deviations), support calibration, method validation, and CAPA implementation while maintaining ERP entries and cross‑functional collaboration.

The role requires preparing QC SOPs, training new chemists, participating in internal audits, and ensuring high quality

Qualifications

• Pharma industry background is required.

Responsibilities

• Overall responsible for Dahej QC activities.
• Ensure 21 CFR Part 11 compliance and contemporaneous entries.
• Coordinate analysis of incoming materials with cross functional teams.
• Oversee calibration, stability studies, method validation with teams.
• Investigate quality management system incidents, deviations, OOT & OOS.
• Investigate customer complaints to identify root causes and CAPA implementation.
• Prepare and revise QC SOPs, manuals and document control.
• Equipment qualification, preventive maintenance and IQ/OQ/PQ cycles.
• Review QA/QC processes, cleaning, sampling, analyzing and documenting.
• Review and approve analytical reports, calibration and qualification reports.
• Enter data in ERP as required.
• Coordinate with external laboratories and service providers.
• Review qualification and preventive maintenance documents.
• Train new chemists per HR/Training schedules.
• Participate in internal audits and address audit observations.
• Ensure compliance to internal and external audits for QC lab.
• Ensure analyses meet specifications; maintain QMS documents.
• Review certification standards and their validity; update specs periodically.
• Review and approve calibration schedules and PM schedules.
• Maintain safety practices in the QC area.
• Communicate departmental activities to CQO daily.
• Evaluate vendor development samples and share with Purchase/QA.
• Prepare change controls for QA support with justifications.
• Adhere to GMP and ensure QC activities follow procedures.
• Follow EHS aspects, policies and procedures.

Skills

Pharma Industry

Job description

Quality Control Management

Candidate should be from Pharmaceuticals and API Industry Back ground.

• 1 Overall responsible for Dahej QC activities.
• 2 Ensuring the requirement of 21 CFR part 11 and implementation in the work area. Ensure contemporaneous entries as per procedure.
• 3 Coordination for analysis of incoming raw materials, packing materials, Intermediates, Finished products in coordination with all cross functional team.
• 4 Coordination for non-routine activities, calibration, and stability studies, method validation, in coordination with all cross functional team.
• 5 Investigation of the quality management system : Laboratory Incidents, Deviations, OOT & OOS
• 6 Customer complaints: Investigation of customer complaints to identify the root cause and CAPA. Implementation of CAPA .
• 7 Preparation and revision of QC SOPs, manuals and document issue control
• 8 Equipment qualification (Design, installation, operation and performance), preventive maintenance.
• 9 Review of the quality management system like cleaning, sampling, analyzing and documenting the process.
• 10 Review and approval of analytical report, calibration reports, qualification reports.
• 11 Entries in ERP as per requirements.
• 12 Coordinate with external laboratory and service provider.
• 13 Review of qualification documents (Design, installation, operation and performance), preventive maintenance documents, calibration documents and etc.
• 14 On job Training to the new chemist as per the training schedule provided by the HR department / Training department.
• 15 Participating in Internal audit and to complete the audit observation and compliance.
• 16 Compliance to internal audits & external audits related to Quality control laboratory.
• 17 Ensuring the analysis as per the specification.
• 18 All QMS documents are to be prepared and review, related with Quality Control department.
• 19 Review of certified reference standards and working standards documents and ensuring the validity.
• 21 Review of Specification and related documents in periodic basis and updating of the same where ever required.
• 22 Review and approval of calibration schedule, preventive maintenance schedule.
• 23 Ensuring the safety practices in the quality control area.
• 24 Departmental activities communication to CQO on daily basis.
• 25 Vendor development samples analysis and sharing the evaluation of samples to the purchase / QA.
• 26 Change control to be filled and submitted to QA for further assistance with proper justifications and documents.
• 27 Adherence to GMP, ensure that QC activities were carried out in line with laid down procedure.
• 28 Follow the EHS Aspects, policy and procedure.