Operations cGMP Compliance Coordinator

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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 Operations cGMP Compliance Coordinator to their team:

1) Serve as cGMP Subject Matter Expert (SME) for the applicable production areas and packaging processes
2) Oversee day-to-day document compliance activities for cGMP operations
3) Review and edit documents for consistency with company policies and SOPs
4) Review operations log books
5) Obtain corrections for log book entries to be in compliance with cGMP
6) Monitor events to establish necessary training for repeat non-compliant entries
7) Monitor tasks assigned to temporary cleaners for cGMP areas; collaborating with contracted company and ensuring separation of non-employee designation remains distinct
8) Ensure temporary cleaners documentation complies with cGMP and FDA requirements
9) Collaborate with continuous improvement projects assuring FDA desire for documented continuous improvement
10) Support the completion of internal compliance assessments and reviews
11) Support the development and effective implementation of CAPAs to address audits, assessments, and inspections
12) Perform document, BPR - SOP review, improvement, and control activities with minimal guidance from management

CRITICAL REQUIREMENTS

  • 1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the pharmaceutical industry is strongly preferred
    4) Preference will be given to candidates with recent experience in operations

    If you are qualified and aspire to work for an excellent, established company whose employees believe in teamwork and make great contributions to the industry, then this could be a golden opportunity for you. 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:
  Clinical Research / Affairs,  Manufacturing,  Engineering
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: