Posted: May 27th, 2021
Closing Date: June 15th, 2021
PSYGEN LABS INC. (PLI) aspires to be a global leader in synthetic and biotechnological manufacture of psychedelic medicines. Our mission is to provide access to psychedelic APIs and drug products for clinical research and therapeutic applications.
Psychedelic drugs are experiencing a renaissance in the clinical treatment of a wide variety of conditions that have eluded widespread successful treatment. Psygen is actively developing commercial infrastructure for the large-scale synthesis and distribution of psychedelic drugs. This is a unique opportunity to be part of a historical transformation in the mental health and addictions treatment sectors.
Psygen provides a competitive compensation and benefits package with solid opportunities for personal growth.
The successful candidate will lead the internal audit program and be responsible for Psygen Operations, supplier audits and supplier control. The position requires high proficiency in establishing an auditing system and working under tight timeframes.
Reporting to the Director of Quality and Compliance, the successful candidate will support team operations in Psygen’s state-of-the-art, 600m2 R&D and commercial scale manufacturing labs at Psygen’s headquarters in Calgary, Alberta.
- Independently prepare, plan, lead and conduct GxP quality audits of Operations, suppliers; prepare and distribute audit reports
- Assist in preparation, planning, and conducting internal audit/self inspection program; prepare and distribute audit reports
- Review and approve external and internal audit response and CAPA plans
- Prepare and maintain supplier audit schedule
- Maintain working knowledge of applicable regulations and standards
- Lead initial and ongoing supplier qualification
- Assist in review of trends and report significant supplier investigation/deviation issues and system deficiencies to senior management, as appropriate
- Creation, review and approval of documentation including supplier control and auditing policies and standard operating procedures (SOPs), compliant to applicable standards (e.g. 21CFR Part 11, GUI-0001, GUI-0004, etc.)
- Actively improve audit system, as well as suggest new audit techniques/approaches
- Lead efforts to ensure readiness for audits and inspections, work with QA team to maintain internal audit program
- Other duties as designated by Quality Assurance Management
- BA/BSc in life sciences, chemistry, pharmaceutical sciences or similar
- Quality Audit Certification (CQA) from an accredited institution preferred
Skills and Experience
- 2+ years experience in quality related role in the pharmaceutical industry, with Aseptic fill experience preferred;
- 2+ years of hands-on supplier quality auditing experience
- Experience with pharmaceutical manufacturing, packaging, testing, calibration, validation, GDP
- Knowledge/experience in ICH and global regulations (e.g. FDA, EMA) and international standards (e.g. ISO, WHO)
- Self starter capable of working with minimal oversight
- Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities
- Excellent oral and written communication skills
- Strong attention to detail
Only candidates selected for an interview
will be contacted.
Psygen is an equal opportunity employer.