QA Compliance Associate
3 weeks ago
**Pharma Medica Research is a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are always looking for top talent to join a growing company committed to making a difference We are currently looking for a **Quality Assurance Compliance Associate** to join our Mississauga team**:
The QA Compliance Associate I is responsible for assisting in and performing corporate compliance activities of the Quality Assurance Department at Pharma Medica Research Inc. (**_PMRI_**). This position reports to the Director, QA and/or designate.
**Duties and Responsibilities**:
- Train **_PMRI_** staff on regulatory compliance and **_PMRI_** compliance procedures (i.e., Quality System, Privacy Polices).
- Assist in the development, maintenance and implementation of **_PMRI_** corporate compliance training programs.
- Audit the **_PMRI_** computerized system validation documentation, equipment qualification and departmental (i.e., IT) documentation and activities.
- Assist in the development and revision of SOPs; perform SOP reviews.
- Administration of the vendor qualification program; maintain vendor qualification documentation.
- Act as a compliance resource by collaboratively interacting with applicable departments to create a positive and effective attitude towards regulatory compliance.
- Maintain and control archive material (i.e., documents, study retention drugs, electronic media) including submissions, retrievals, storage, and disposal. Maintain the archive database.
- Additional duties as required.
**Qualifications**:
- B.Sc. degree, Post-Secondary Diploma in scientific, healthcare, or pharmaceutical field, or equivalent combination of education and related experience
- 1-3 years related experience (combined or equivalent) in quality assurance and/or related regulatory role
- Knowledge of applicable regulations (i.e., GLP, GCP, Privacy, 21 CFR Part 11).
- Excellent communication and interpersonal skills
- Possess enthusiasm and effective training capabilities
- Work effectively independently and as a team member
- Effective organizational skills
- Must be proficient in and willing to stay current with regulatory requirements and other appropriate governing body regulations and guidelines
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