Quality and Compliance Manager - QP (Pharmaceutical)

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.

• 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

• 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

• Health Insurance
• Attractive Bonus and Salary