Quality Manager



Not ready to apply?

Quality Manager

The main purpose of the Quality Manager position is to assure the consistent quality of the Medisca products and compliance with the regulations (FDA, Health Canada, cGMPs).

MEDISCA is a fast paced global pharmaceutical company working in a niche market for over 25 years. We offer a great benefit package along with competitive wages and unlimited growth opportunity.

For more information please visit our website at: www.medisca.com

Join our Talent Network: http://www.jobs.net/jobs/medisca/en-us/join

Are you looking for a career in the pharmaceutical industry?

See below for the main functions of the Quality Manager.

Please submit your resume in Word format to facilitate the delivery of your application.

JOB DUTIES:

  • Host all Regulatory Inspections
    • Primary person responsible for hosting all MCA regulatory inspections
    • Provide inspection details at the end of each inspection day for review
    • Discuss observations and implement corrective actions

  • Review and Approval of Quality Events
    • Approval of deviations, NCMRs, Customer Complaints, CAPAs
    • Establish necessary Corrective and Preventive Actions related to all Quality Events
    • Perform complete risk assessment and root cause analysis using 3 legged 5 why and/or Ishikawa Diagram

  • Review and Approval of MEDISCA's Standard Operating Procedures
    • Collaboration and Approval of Standard Operating Procedures
    • Ensure Standard Operating Procedures are aligned with external regulations that govern the compounding industry

  • ISO 9001 and ISO 13485 Management Representative

  • Internal Audits
    • Schedule yearly internal facility audits
    • Conduct cGMP internal audits against industry regulations and MEDISCA Standard Operating Procedures
    • Initiate Corrective and Preventive Actions based on internal audit results

  • Document Control
    • Oversee creation and approval of companywide documentation
    • Ensure Certificates of Analysis, Safety Data Sheets, Specification Sheets, MEDISCA labels meet industry standards

  • Supplier Qualification
    • Review and Approval of Quality Agreements between MEDISCA and suppliers/manufacturers
    • Oversee supplier qualification process

  • Quality Projects and Continuous Improvement Initiatives
    • Assist with all Quality Project Initiatives and apply LSS methodologies

TRAVEL: One (1) month per year to perform laboratory audits and attend meetings

Required Skills:
  • Knowledge of cGMPs, 21 CFR Part 211, GUI-0104, GUI-0069; ICH Guidelines, ISO 9001:2008; CDSA regulation.
  • Previous experience in supervision and/or management
  • Very good command of Microsoft Office (Word, Excel, Outlook)
  • Excellent communication skills required; fluent English (oral & written)
  • Leadership, time management, analytical and decision making skills

Required Experience:
  • Bachelor of Science
  • Minimum of five (5) to seven (7) years in regulatory affairs and quality systems

If you feel that you have the skills required for this Quality Manager position and would like to join the pharmacy compounding industry, apply now:

https://medisca-en.silkroad.com

Join our Talent Network: http://www.jobs.net/jobs/medisca/en-us/join

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.


 

Company Overview


MEDISCA Pharmaceutique Inc is an FDA (Food and Drug Administration) registered supplier of fine chemicals, which include: - Active pharmaceutical ingredients (APIs) - Excipients in the form of bases, oils, colors, and flavors - Reusable and disposable devices for compounding pharmacists across the United States, Canada, Australia, and Europe. MEDISCA Pharmaceutique Inc is committed to bringing to the pharmacy compounding community the highest quality fine chemicals, compounding supplies, compounding solutions, and training.

MEDISCA Pharmaceutique Inc's trusted partner and educational arm, MEDISCA Pharmaceutique Inc NETWORK supports ACPE-Accredited pharmacy compounding training programs: Certificate Programs in Pharmacy, workshops, and symposiums. MEDISCA Pharmaceutique Inc NETWORK's Technical Support Services Department provides customized and on-line formulas, along with a customer service help line to answer compounding-related questions regarding compounding equipment, compounding scripts, and compounding medications.


Not ready to apply?

Almost there!

Submit your email address to begin the application process for the Quality Manager job. .

Email is invalid Email address is needed

By applying to a job using CareerBuilder.com you are agreeing to comply with and be subject to the CareerBuilder.com Terms and Conditions for use of our website.