SUMMARY:

Supervise the activities of the calibration (Metrology) group in the performance & validation of all new and existing analytical equipment according to a set schedule and current Patheon Standard Operating Procedures (SOPs), Good Manufacturing Practices, Good Laboratory Practices (GLPs) and corporate quality standards. Provide support in monitoring business process performance measures and advise management of potential quality or regulatory issues that may affect product quality of regulatory compliance.

EDUCATION:

Minimum Bachelor of Science (B.Sc.) in Chemistry or a science related to pharmaceutical analysis

EXPERIENCE:

Proven experience in quality control/analytical development within the pharmaceutical industry
Previous Supervision and/or leadership and training experience
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.

KNOWLEDGE, SKILLS AND ABILITIES:

Previous method and analytical instrumentation validation experience in the pharmaceutical industry. Possesses a highly developed quality, regulatory and production attitude including an appreciation for client service and contract manufacturing. Excellent knowledge of Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge. Well organized and detail oriented. Strong interpersonal and communication skills (both oral and written). Demonstrated leadership skills. Ability to read, analyze, and interpret technical procedures and governmental regulations. Experience with Microsoft Office Applications. Proficiency in the English Language.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally

• Supervises a Team of 4-6 Scientists who are responsible for the execution of laboratory instrumentation preventative maintenance, qualification and validation activities.
• Ensures instruments are calibrated and preventative maintenance is performed as scheduled.
• Assigns tasks within the group to ensure completion.
• Performs routine calibration and validation of all equipment according to schedule.
• Assigns tasks within the group to ensure completion.
• Updates calibration, performance verification and preventative maintenance SOPs to keep current with Good Manufacturing Practices requirements.
• Coordinates external outside calibration and preventative maintenance services, if required.
• Performs Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) on all new equipment.
• Maintains the calibration and preventative maintenance schedules for each new and existing piece of analytical equipment.
• Sets up systems to continually improve the metrology, lab assistants and QC laboratories to ensure increasing effectiveness of service.
• Performs and completes performance appraisals throughout the year.
• Selects, develops and evaluates staff to ensure the efficient operation of the function. Works with and advises staff on administrative policies and procedures.
• Performs alternating or rotating shift work (as required)