Pharmacovigilance Compliance Expert
hace 4 semanas
About Qualifyze
We are a leading company in supply chain compliance management in the Life Sciences industry, trusted by over 1,200 pharmaceutical and healthcare companies globally.
Our digital suite of solutions connects manufacturers, suppliers, and a global network of more than 250 auditors and quality experts.
With a track record of over 3,000 audits across 85+ countries and the largest and most accurate supplier network and data analytics tools, Qualifyze stands as the all-in-one partner for quality compliance and supply chain risk mitigation in the Life Sciences sector.
Job DescriptionWe are seeking a Quality Assurance Specialist to join our team and contribute to maintaining and improving our high standards of service quality and compliance.
This role is essential in ensuring that all our auditing processes, particularly in the area of Pharmacovigilance (PV), are aligned with the applicable GxP standards and regulations.
The candidate will play a key role in audit preparation, supervision, and report oversight to ensure compliance with the highest quality standards.
Key Responsibilities- Ensure that our services meet all the necessary requirements before they reach the consumer.
- Perform accurate audit preparation to provide the related documentation to the auditor and the auditee.
- Oversee audit reports (mostly from PV audits) to identify deviations from quality standards and ensure compliance with applicable standards while meeting customers' expectations.
- Co-supervise auditor performance and provide guidance and feedback.
- Participate in audits (specifically in PV) as an auditor, co-auditor, or observer.
- Identify opportunities for improvement and recommend corrective actions.
- Contribute to the definition and maintenance of Qualifyze's common voice related to technical aspects, ensuring consistency across documentation and communications.
- Degree in pharmacy, chemistry, biology, or a similar field of study with a strong science/healthcare base.
- 3+ years of experience in quality assurance, preferably in a GxP environment.
- In-depth GxP knowledge, specifically GVP (Good Pharmacovigilance Practices). Additional knowledge of GCP and GMP is a plus.
- Strong communication skills in both written and spoken English. Proficiency in other languages is appreciated.
- High computer and tech affinity, with proficiency in MS Office tools.
- Ability to present a professional demeanor when interacting with clients, auditors, and teammates.
- Open, communicative, and collaborative approach to work.
- Flexible schedules throughout the year.
- Monthly restaurant/transportation vouchers.
- Health insurance policy with Assistència Sanitària (for Spain-based employees), with the option to add family members.
- Wellhub wellbeing platform membership.
- The option to work from abroad for up to 3 months per year.
- All the necessary work equipment (laptop, headphones, etc.).
- Two official company events per year to celebrate success.
- Individual coaching and mentoring on your development roadmap within Qualifyze.
We actively support the power of diversity, uniting complementary talents and perspectives to address new challenges.
We appreciate what makes you unique, be it your background, experiences, or any other factors that shape your identity.
We welcome applications from individuals of all backgrounds, regardless of race, ethnicity, gender identity, sexual orientation, marital status, religion, disability, or age.
We are dedicated to fostering a culture where everyone feels valued and empowered.
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