Quality Assurance Specialist

3 weeks ago

Markham, Canada Shields Pharma Inc. Full time

Shields Pharma Inc. is looking for qualified and experienced employees to join the successful team. We currently have the following full time positions available for Markham, Ontario:
**Quality Assurance Specialists**

**Reports To: Manager of Quality**

Outstanding opportunity for Quality Assurance professionals to join our company based in Markham as Senior Quality Assurance Specialists. As the Quality Assurance Specialist you will be responsible for the maintenance of the QA function and ensuring compliance according to GMP (Good Manufacturing Practice), and will perform activities to assure compliance with applicable regulatory requirements by conducting audits, supporting training programs, data and documentation reviews and analysis.

**Overall Responsibilities**:

- Manage the GMP Documentation, Change Control, CAPS, OOT, OOS, Training Record systems.
- Review and approve CoA and other quality documentation
- Review validation activities
- Assess regulations
- Develop quality policy
- Perform timely data review with a high focus on data quality to ensure accuracy and completeness of analytical testing documentation.
- Oversee Quality Control documentation to enforce good documentation practice to improve accuracy, GMP compliance and neatness of analytical documentation
- Verify calculations and documented information such as reagent expiry, instrument calibration, logbook entries, control charts etc are present and complete and accurate.
- Review internal logbooks for incoming samples, standards, reagents, equipment etc.
- Issue and reconcile Quality Control laboratory workbooks and other GMP documentation.
- Audit and inspect laboratory equipment daily use logbooks
- Ensure analysis performed are as per client’s specification
- Track tests in progress and issue periodic status reports
- Support training initiatives by implementing training program, including monitoring effectiveness of program and ensure training records are compliant
- Implement Quality Policies and Procedures for on-site test activities
- Develop, implement and update QA Manual, QA Supplement Manual and standard operating procedures
- Prepare, review and approve Standard Operating Procedures (SOPs)
- Coordinate documentation activities to ensure compliance with GLP and GMP
- Archive and retrieve quality control data
- Audit and inspect laboratory operation and activities
- Audit and review data for accuracy, completeness and regulatory compliance
- Detailed audits of draft reports for compliance with SOP’s and GLP regulations
- Participate in client audits and inspections
- Oversee the laboratory investigation
- Perform Annual Internal Audit, and work with Analytical Lab personal to ensure follows up and corrective actions are completed.
- Periodic review of training records, SOPs, Change Control implementation, Deviation and OOS investigation
- Data-review and data-verification activities
- Maintaining and issuing controlled numbers in support of site-wide document control
- Tracking document requests and ensure completion of outstanding items
- Conduct QA investigation with regard to Out-of-Specifications, Exceptions and Corrective Action. Monitor effectiveness of corrective and preventative actions.
- Assist in the review and approval of GMP documents such as SOPs, and associated forms, and initiate revisions.
- Evaluate laboratory results and keep trending of Shields Pharma Inc. Stability studies and write assessment reports of these programs annually.
- Any other tasks assigned by the Shields Pharma Inc. senior management

**Education and Experience**:

- University Degree in Science - preferably in Chemistry coupled with experience in the review of raw material, finished product, stability and analytical method validation documentation.
- Have experience in a Quality Assurance leadership role with minimum of 3 yrs quality experience in a regulated pharmaceutical environment, within QA, QC, and/or Regulatory Affairs disciplines.
- Have expert experience of GMP Thorough understanding of pharmaceutical QA Systems, US, EU, and Canadian GMP regulations
- Knowledge of GMP, GLP, Compendia, analytical techniques
- You should have excellent verbal and written communication skills, interpersonal skills and you should be extremely results driven and organized
- You must demonstrate good written and oral communication skills in English

**General Skills**:

- The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Must be willing to work in a team-based environment
- Must have solid math skills
- Must be able to work with limited direct supervision
- Must have good problem solving/organizational skills
- Must have excellent computer skills
- Must have strong writing and communication skills in English
- Must have the ability to analyze data
- Must be attentive to detail
- Must have excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, an

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