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Observe established escalation process for laboratory issues that impact established production-related Service Level Agreements (SLAs) and/or the fulfillment of production goals.

Participate in deviation investigations.

Author documents that ensure cGMP compliance, such as laboratory investigation, deviations, change controls, change notices, analytical test methods; analytical test method development reports; method validation protocols; method transfer protocols and reports; method verifications protocols and reports; and instrumentation qualification documentation (URS/IQ/OQ/PQ).

Seek process innovation and continuous process improvement and perform quality improvement initiatives in the laboratory to meet site production goals.

Support and adhere to established processes and productivity targets.

Recognize and report to immediate supervisor any issues or deviations from accepted standards.

Provide status updates on own activities and productivity challenges according to defined procedures.

Complete and conform to all training requirements for job role, including company-required and job role-specific training.

Requirements

A third level qualification in Chemistry or related Science, preferably a bachelor’s degree with 6 months + GMP experience with relevant Quality Control experience.

Experience in pharmaceutical manufacturing facility.

Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.

Demonstrate competency in the operation, calibration and qualification of common analytical instrumentation e.g. HPLC, Dissolution, GC, FTIR, Electro Chemistry (DME), UV/Vis and other USP instrumental and Wet chemistry technologies used in pharmaceutical Quality Control Laboratory.

Demonstrate strong analytical laboratory skills and laboratory troubleshooting abilities.

Demonstrated success in making effective and persuasive presentations on complex topics to upper management.

Qualifications

Bachelors Degree , Third Level Qualification in science , Degree in science or chemical engineering

Skills

Communication Skills
Management Skills
Quality Assurance
Quality Control
Quality Improvement
Analytical Skills
Strong leadership Excellent communication Problem solver Analytical focus Strong listening & interpersonal skills

Experience

6 months

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