Quality and Compliance Manager - QP (Pharmaceutical) - Quality Assurance jobs in Malta - May 2024
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Quality and Compliance Manager - QP (Pharmaceutical)

Konnekt

Published on 16 May 2024

Expires in 16 days (15 Jun 2024)


Our client who specializes in the Pharmaceutical industry is looking for a Quality and Compliance Manager - QP. Your roles and responsibilities will include: 

  • Coordinated QP related activities, ensuring timelines are met effectively and efficiently
  • Prepare and periodically review standard operating procedures as required
  • Ensure that the quality system is prepared and maintained in accordance with all relevant regulatory guidance
  • Ensure that all products are manufactured and documented in accordance with the appropriate regulatory requirements
  • Ensure that an effective stability programme is in place and any Out of Trends and Out of Specification are being reported and investigated appropriately
  • Ensure that any non-conformances with procedures or cGMP is investigated, documented, properly reported and resolved according to the relevant standard procedure
  • Approve and close-out any Customer Complaint Investigations and, in case of a Critical Product Quality Complaint or potential recall, responsible for alerting higher management and/or notifying health authorities as necessary
  • Take a final decision on batch disposition and release and certify batches to be used for human consumption and IMP purposes
  • Coordinate the timely preparation of documentation for dossier submission.
  • Coordinate Regulatory Requests and provide the necessary support to address queries arising by assessors/Contract Giver during the dossier reviewing stage.
  • Coordinate and provide the necessary support for the preparation of variation packages by the Contract Giver’s Regulatory and Compliance Team
  • To be responsible or pharmacovigilance for the company’s products
  • Contribute in the execution of self-inspections and external audits as required.
Requirements
  • A minimum of two (2) years of progressive management experience or senior supervisory role and as a Qualified Person
  • Able to adhere to targets/deadline
  • Good written and oral communication skills with particular emphasis on presentation skills
  • Problem solving, leadership, conflict management, and team building skills in order to ensure a productive work environment and achievement of goals
Education and Experience
  • Bachelor’s Degree in Chemistry, Pharmaceutical Science or related field from an accredited college or university.
  • Registered as a Qualified Person with the Pharmacy Council
Benefits
  • Health Insurance
  • Attractive Bonus and Salary

time
Full Time
Job Type
experience
Senior Management
Experience Level
category
Quality Assurance
Category
industry
Healthcare
Industry



Qualified Person

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