Overview

Quality Assurance Manager Jobs in San Gwann, Malta at Adalvo

Title: Quality Assurance Manager

Company: Adalvo

Location: San Gwann, Malta

At Adalvo, we're not just a company – we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, we are fast, we are always on target, we are Adalvo! 🎯 🚀

We are looking for a Quality Assurance Manager (EU QPPV) to join our dynamic team. If you're someone who thrives in a fast-paced environment and loves tackling new challenges, then this is the perfect opportunity for you.

SUMMARY OF POSITION:

The EU QPPV & QA Manager is responsible for the establishment and maintenance of the marketing authorization holder’s pharmacovigilance system, ensure training for all personnel regarding pharmacovigilance activities and supports the QA Team.

ORGANIZATION STRUCTURE:

This role will report directly to the SVP Quality.

RESPONSIBILITIES:

Primary responsibilities of this role include the following:

Detailed description of main QPPV tasks:

  • Having an overview of medicinal product safety profiles and any emerging safety concerns;
  • Maintaining and coordinating the pharmacovigilance system to ensure that all adverse events in relation to all substances from the portfolio are collected, collated and handled at a single point within Adalvo Group within the European community.
  • Having oversight of the functioning of the system in all relevant aspects, including its quality system (e.g. standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance).
  • Overview of all processes and procedures that are in place in the pharmacovigilance department Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP;
  • Ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the Agency.
  • Overview of compliance in relation to the quality, completeness and timeliness of aggregate reports.
  • Overview of compliance in relation to the quality, completeness and timeliness of ICSRs;
  • Ensuring that all pharmacovigilance documents (PSURs, PSDRs, RMPs) are prepared in time and are quality controlled.
  • Ensuring that all ICSRs received or collected are entered in the database.
  • Ensuring that all ICSRs that need to be expedited are handled and sent in a timely manner.
  • Being aware of the validation status of the database, including any failures that occurred during validation and the corrective actions that have been taken to address the failures.
  • Being informed of significant changes that are made to the database (e.g. changes that could have an impact on pharmacovigilance activities).
  • Ensuring that any request from the competent authorities in Members States and from the Agency for the provision of additional information necessary for the evaluation of the benefits and risks is answered fully and promptly.
  • Providing any other information relevant to the risk-benefit evaluation to the competent authorities in Members States and the Agency for Adalvo products.
  • Providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals).
  • Initiating variations or urgent safety restrictions, when needed.
  • Establishment of overview of aggregate reports preparation, safety surveillance, risk management evaluation, risk management plans, risk minimisation measures.
  • Being aware of and decide as needed over the content of risk management plans.
  • Being involved in the review and sign-off of protocols of post-authorisation interventional safety studies conducted in the EU (if any) or pursuant to a risk management plan agreed in the EU.
  • Having awareness of Post Authorization Safety Studies (if any) requested by a competent authority including the results of such studies.
  • Has the power to recall products for safety reasons or to initiate safety variations as needed;
  • Receiving information on new marketing authorisations, launches, withdrawals, changes in MA holders, safety related changes.
  • Having awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products.
  • Making sure that all relevant employees are trained in relation to pharmacovigilance activity.
  • Acting as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency on a 24-hour basis and also as a contact point for pharmacovigilance inspections.
  • Implementing the corrective actions related to pharmacovigilance inspections and audits.
  • Being responsible of Medical Devices and Combination Products SOPs and documentation.
  • Negotiate Quality Agreements with Partners.

QUALIFICATIONS & REQUIREMENTS:

  • Bachelor’s degree in pharmacy, life science, or similar
  • 3+ years of professional experience in a similar position
  • Strategic thinking and good business acumen
  • Strong leadership and negotiation skills
  • Ability to drive, change and support continuous improvement
  • Proficiency in English

CORE COMPETENCIES:

  • Target Driven
  • Smart Networking
  • Teamwork
  • Relentless Customer Focus
  • Optimistic

Why join us?

🎯 Exciting Challenges: Every day brings new opportunities to learn and grow.

🎯 Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard.

🎯Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities.

🎯Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements.

🎯Fun and Inclusive Culture: We believe in celebrating our successes and building strong connections within our team.

Ready to Ignite Your Passion?

If you're ready to take the next step in your career and join a business committed to consistently deliver high-quality products and services, then we want to hear from you! Send us your resume today!

Please be informed that only selected candidates will be contacted.

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