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Manager – Quality Assurance and Control
The vacancy has expired
- LocationMumbai
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IndustryPharma, Biotech, Healthcare & Medical Devices
Job Description
Job Purpose
- Improve, establish, and implement the inspection and quality system.
- Implementation of quality assurance plan and follow the activity done according to QAP at vendor site as well as in a factory.
Key Responsibilities
- Coordinate with Production, Purchase, and Design Department to analyse and resolve customer complaints and identify and fix the root causes.
- Monitor Analysis of supplier rejection & monitor effectiveness of CAPA implementation at Supplier with documented SCAR, 8D, FMEA, and 5 why analysis.
- Ensure priorities job to be scheduled & delivered on time as per requirements repairing/Presentation the Data report of the department.
- Worked on minimizing on repetition of issues by collecting data of machines. To develop SOPs and checklists to improve quality by minimizing quality points during final inspection/FAT.
- Checking FAT DQ / IQ/OQ as per General Assembly Diagram of all machines.
- Define Departmental objectives & assessment parameters for all the departments based on organizational goals.
- Monitor & manage the processes of finished good testing and Dispatch QA. Impart training to inhouse & Supplier engineers and operators
- ISO 9001:2005 implementation and its QMS requirements.
- Maintaining records of Calibrated instruments and calibration history charts.
- Preparation of Weld plan/Weld Map, Welder cards, monitoring of welder’s performance and updating welder qualifications and conduct welder procedure qualification / Welder performance qualifications as per ASME Code.
- Inventory management and operational excellence.
Reports to: EVP - Engineering.
Compensation: Competitive, and negotiable based on experience
Mandatory Qualifications/ Skills
- Bachelor of Engineering, Mechanical (First Class or Distinction).
- 10- 12 years of working experience in Quality Assurance and Quality Control Department.
Preferred Skills/ Qualifications
- Experience in Pharma Equipment's /Machinery/Pressure Equipment
- Comprehensive Knowledge of National and international codes ASME Sec II Part A, SEC VIII DIV I, Section IX, Section V.
- Implementation of ISO 9001.
Job Requirements
- Full-time position based out of Thane, Maharashtra.
- Ability to use ERP software.
- Working in a fast-paced corporate environment.
- Detail oriented and meticulous.
- Ability to develop strategies and organize tasks
- Leadership and interpersonal skills
