| Reference Number: 92 |
| Location |
Belleville Ontario |
| Reports To: |
Director of Quality Assurance Manager |
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| Description |
Overall Job Summary
The QA Specialist is responsible to monitor the facility for GMP compliance by maintaining specific GMP support programs related to activities at the Belleville site.
Specific Accountabilities
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Ensures continued GMP compliance for the Belleville facility. This will include completing all annual internal GMP audits as per approved schedule, maintaining audit records and documenting follow-up from audits.
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Assists the QA Analysts to ensure investigations and documentation of quality deviations and inventory reconciliation issues are recorded, addressed and resolved
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Ensures customer complaints and corrective actions are recorded, addressed and resolved.
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Develops and delivers GMP training to employees, maintains on-going training records and ensures staff receive annual GMP updates.
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Provides support to the maintenance of the Returned Goods Program, Pest Control Program and systems for Product Quality Review, Corrective Actions and Product Destruction.
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Provides support to the Director of QA in ensuring control and documentation management systems are current to meet GMP and Technical requirements. Counsels staff regarding the appropriate GMP aspects as issues arise.
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Responsible to complete batch record reviews and final sign off
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Investigates and prepares annual IRF reviews, product quality reviews, and additional reviews as required
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Works with interdisciplinary teams in the investigation and resolution of special projects resulting from IRFs, CPA’s, Recalls, Customer concerns, etc.
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Provides back-up to ensure Quality Assurance production requirements are met. This includes issuing required production documents, providing QA line clearance, on-line inspection and final review of completed manufacturing and packaging documents.
Education, Work Experience & Competencies
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BSc. required
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Three years experience in a manufacturing environment with minimum one year in a Quality Assurance role
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Preference will be given to candidate with a pharmaceutical background who has had compliance auditing experience and a strong knowledge of GMPs
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Technical skills include above average report writing and computer skills
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Excellent communication skills required to ensure information is freely exchanged by and expressed to incumbent
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Professional attitude in sharing information to encourage cross-departmental collaboration to solve problems and achieve mutually dependent goals
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Strong attention to detail required to ensure complete accuracy of information
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Ability to work independently with a minimum of supervision
Working Conditions
This position will be split between a production and office environment. There will be a moderate to high level of mental effort to support the needs of the manufacturing and quality organizations and to react positively to the control of GMP issues as they arise.
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Exposure to odors
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Exposure to chemicals
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Expose to biohazards
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Exposure to high levels of noise
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Personal protective equipment required
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Must be able to wear full and/or partial face masks
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Work requires fine detail reading
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Extensive computer use required
Conclusions
The Job Description outlines the Key Accountabilities of the position and should not be considered a detailed description of all requirements that may be inherent in the job.
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Be sure to include the reference number of the position and attach your resume.
