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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
Konnekt: Established in 2007, Konnekt has grown into Malta's leading job agency. Our team is here to simplify your job search by presenting over 400 career options across various fields. We have robust connections with top employers in Malta, making us the ideal choice for anyone considering a career change.
At Konnekt, we believe in straightforward actions and staying true to our values. This commitment has been the driving force behind our success. Whether you're seeking new opportunities or exploring a different career path, we are your reliable partner throughout the process.
Our website provides more insights into our approach and the array of services we offer. Take a moment to explore and discover how Konnekt can be instrumental in shaping your professional journey.
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
Konnekt: Established in 2007, Konnekt has grown into Malta's leading job agency. Our team is here to simplify your job search by presenting over 400 career options across various fields. We have robust connections with top employers in Malta, making us the ideal choice for anyone considering a career change.
At Konnekt, we believe in straightforward actions and staying true to our values. This commitment has been the driving force behind our success. Whether you're seeking new opportunities or exploring a different career path, we are your reliable partner throughout the process.
Our website provides more insights into our approach and the array of services we offer. Take a moment to explore and discover how Konnekt can be instrumental in shaping your professional journey.