QA Auditor Ii

4 weeks ago

Mississauga, Canada Cliantha Research Ltd. Full time

**Roles and Responsibilities**:
**1) **Prepare and conduct routine internal audits of projects conducted as scheduled. These audits are intended to assess Cliantha Research site’s compliance with Good Regulated Practices (GxP), Cliantha Research Quality System Documents (such as SOPs), study protocols, pertinent industry regulations and guidelines; they include, but are not limited to, the following:
**i. **Pre-study (documentation) audits

**ii. **In-process (procedures and documentation) audits

**iii. **Post-study (documentation) audits

**iv. **Statistics and/or pharmacokinetics audits

**v. **Clinical study reports audits

**vi. **Data management audits

**vii. **CDISC audits

**viii. **Trial Master File audits

**ix. **Validation reports

**2) **Review protocols, informed consent forms, source document templates/logs and other project-specific documentation not otherwise reviewed formally in an audit.

**3) **Prepare and conduct external audits for clinical trial projects to ensure compliance with SOP, Protocol, ICH GCP, quality system and applicable regulatory requirements

**4) **Prepare and conduct routine process/system audits, as well as audits of validation and/or qualification of computerized systems and facilities.

**5) **Prepare and conduct qualification audits of 3rd party vendors that provide goods and/or services that support GxP activities at Cliantha Research.

**6)**

**7) **Keep QA Management up to date with findings and follow up on corrective actions.

**8) **Analyze and evaluate available data and timely prepare written Audit Reports of findings and observations to be shared with site and senior management as per SOP requirement.

**9) **Perform adequate and timely follow-up of audits, and issue Quality Assurance statements/certificates for audits conducted.

**10) **Maintain various QA trackers/logs (deviations, change control, audits etc.) up to date.

**11) **Assist the site and QA management in the identification of quality process improvement opportunities and in the development of new processes, documentation and other tools.

**12) **Work with the Quality Assurance group in the development/revision and implementation of Standard Operating Procedures as required.

**13) **Ensure compliance with appropriate Cliantha Research SOP’s, GCP and ICH guidelines.

**14) **Keep personal training file updated on a regular basis.

**15) **Work in a safe manner that does not endanger yourself or co-workers.

**16) **Uphold the company mission statement and conduct yourself at all times in a respectful and business-like manner. Be a positive role model for all staff and interact with colleagues in a collaborative way.

**17) **Assist with the archiving of study documents, as needed

**18) **Execute other duties as may be required by QA Management and other members of the Management team as training and experience allow.

**_Any Additional responsibility given by Head of the Department / Management_**

**Qualifications**:

- Minimum of Bachelor Degree in a related field or sufficient equivalent relevant training and experience as judged by the site QA management.
- Minimum of two years’ experience in quality review of documents and processes in various phases of clinical trials.
- Practical knowledge of, and remaining current with, regulatory requirements pertaining to clinical &/or pre-clinical research (HPFB, FDA, EMA, MHRA, GxP, etc.).
- Attention to detail and the ability to spot inconsistencies a must.
- Ability to understand and follow basic scientific research protocol and procedure.
- Well-developed analytical and problem solving skills, and have the ability to analyze and interpret scientific data. Proactively identifies problems and helps others with problem solving.
- Decisive, good decision making skills, able to provide leadership to others in response to situations and to escalate more critical decisions when relevant.
- Effective customer service and conflict resolution skills.
- Strong analytical and problem solving skills
- Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
- Excellent interpersonal skills
- Strong written and verbal communication skills

Schedule:

- 8 hour shift

Ability to commute/relocate:

- Mississauga, ON: reliably commute or plan to relocate before starting work (preferred)

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- reviewing clinical trails documents: 2 years (preferred)

Shift availability:

- Day Shift (preferred)

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