Senior Quality and Compliance Specialist

Sterling-Hoffman Executive Search Located in: Ontario
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JOB DESCRIPTION

We are seeking a driven individual with a passion for the pharmaceutical industry. One of our clients is looking to add a strong Senior Quality and Compliance Specialist to their team. Responsibilities include:

1) Perform full reviews of manufacturing records, analytical data and other associated documents
2) Identify contractors and negotiate contracts
3) Review and approve lifecycle documentation
4) Review and approve validation protocol deviations
5) Review documentation for equipment, utility and facility shutdown and startup
6) Provide assessments for change orders on direct impact systems
7) Identify qualification requirements to ensure the validated state is maintained
8) Approve change control requests for all validated systems, equipment and automation changes
9) Develop process validation protocols and prepare reports
10) Participate in compiling and reviewing data for monitoring and trending key compliance indicators

CRITICAL REQUIREMENTS

  • 1) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    2) Recent experience in the pharmaceutical industry is strongly preferred
    3) Preference will be given to candidates with recent experience in quality and compliance

    This position is critical to the team and requires a talent who is both driven and highly skilled. We are looking for real go-getters here, so if you are both qualified and ready to make an impact, please apply ASAP!

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Quality,  Compliance
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: