About this role
We’re hiring a Quality Assurance Associate for our client, a global pharmaceutical company, to join their team. This is a 10-month contract opportunity concluding in September 2021.
- Assessing the content of regulatory dossiers and comparing the information with operational documents (SOPs, SWIs, BPRs, etc.) and identify potential gaps
- Categorizing identified gaps in partnership with IA/SQO/Regulatory CMC
- Liaising with IA, SQO and Regulatory Affairs as required to verify the identified gaps and ensure appropriate documentation of gaps in addition to remediation plans
- Proposing the gap resolution actions concerning the update of the industrial practices and documentation.
- Authoring (if appropriate, depending on the organization per site), reviewing and approving the LC documentation including relevant protocols and report(s).
- Bachelor’s degree in life sciences
- Technical writing experience and the ability to write clear GMP documentation
- Candidate to be familiar with cGMP requirements (US FDA, Europe and Canada)
- 1+ years of Quality Assurance experience would be an asset, preferably in biologics
- Ability to work in a group setting and independently; good teamwork skills
- Ability to adjust to changing priorities and to manage multiple priorities efficiently
- Detail orientation is critical for this role, given the required depth of required assessments.
- Strong interpersonal and communication skills, both verbal and written
- Strong organizational and time management skills
- Results oriented
- Ability to project and maintain a professional and positive attitude
- Strong planning abilities where potential issues are anticipated and communicated early enough to allow timely resolution
- Experience working with basic computer software, including MS Word, Excel, and PowerPoint, in addition to Cloud-based platforms, required.
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- Certifications (optional)
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Maria Camanag is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Toronto
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