Team Leader, QA

4 weeks ago


Ajax Ontario LH, York region, Canada Colgate Full time
Job Title: Team Leader, QA

Job Purpose:
Position is responsible for Quality Control Program. He will work in the Analytical/Chemical lab & will ensure Input material, WIP & Finished goods are sampled, tested & approved timely and in compliance to CP Standards/guidelines & applicable local regulatory requirements. He is also responsible for qualification & maintenance of lab equipment. He will drive continuous improvement in the areas of Quality, Good Manufacturing Practices, Good laboratory Practices & EOHS.

Job Context:

  • TL quality has to follow and ensure compliance for physical and chemical sampling/testing program for Raw materials, Work-in-process (WIP) & Finished products at the facility based on Quality Standard expectations & local regulatory requirements.
  • Ensures Lab equipment/instruments Qualification (DQ,IQ,OQ,PQ), Calibration Verification & Maintenance Program as per the defined procedures & protocols. Understands equipment Basic Operation & performance evaluation & assists in equipment breakdowns & trouble shooting.
  • Understands Hazards associated with Lab Equipment, Lab Chemicals, Lab Operations.
  • Implements effective & efficient lab safety program. Partners with site EOHS program & drives key aspects of Site EOHS program applicable to laboratories.
  • Participates in Internal audits and External audits (Contract manufacturers and Labs, Suppliers, etc.) Functions as part of the Plant GMP and Quality Team.
  • The Team Leader is an effective and valuable member of the Management team to ensure delivery of business results in his area. This position requires having a high degree of interface with Making, Finishing, and Materials.

Key Accountabilities:

Ensuring RP/PM Quality , WIP & FG:

  • To follow physical and chemical sampling and testing program for raw materials, work-in-process (WIP) & finished products at the facility.
  • This must be in compliance to QS 024 and local regulatory requirements.
  • Timely testing and release of RM/WIP/FG to support plant KPIs of AU & UPDT

Ensure use of corporate lab methods, IQ/OQ/PQ of Lab equipments, Calibration Documentation:

  • Ensures all testing is performed according to corporate methods, laboratory requirements, applicable regulatory requirements, and policy.
  • Maintain laboratory quality assurance system that covers analyst qualification as well as equipment IQ/OQ/PQ, calibration, maintenance and use of analytical reference standards.
  • Ensures that the reporting of data and maintenance of records is documented. Also, that the interpretation of the data is correct and that the results are effectively communicated to appropriate individuals including management.
  • Participates in internal audits and external audits (contract manufacturers and labs, suppliers, etc.) Functions as part of the Plant GMP and Quality Team.

Continuous improvements:

  • Integrates and applies CI tools to drive KPI improvements
  • Exploits data and information to identify and measure potential improvements

FP&R & EOHS

  • Understanding the technical requirements of EOHS, Product Safety, Regulatory, and Quality and Microbiology in factories, laboratories, and research facilities.
  • Takes corrective actions in a timely manner to mitigate potential EOHS or Quality incidents
  • Abides by facility safety and GMP requirements and sets the example
  • Proactive in self-assessing against corporate EOHS and Quality standards and governmental regulations
  • Follow FP&R laid down standards applicable to the area.

Compliances:

Adherence to policies & procedures of the company, production processes and systems/SOP’s & regulatory requirements.

Cost Reduction:

Identify, recommend and implement manufacturing cost reduction program, execute new technology in the area.

Communication:

Coaching & Feedback, DBS

Experience: Minimum of 3-4 years of laboratory experience in a regulated environment, having good skills on analytical instruments HPLC, GC, AAS, FTIR, UV-VIS spectrophotometer, NIR, NMR, pH meter etc. Adequate communication & presentation skills required.

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