Qualified Person (QP)
J&J Family of Companies
We are seeking a qualified and experienced QP (Qualified Person) Pharmacist to ensure that our imported pharmaceutical products meet the highest quality standards and comply with Israeli regulations. The ideal candidate will be responsible for overseeing quality assurance activities related to the importation of pharmaceutical products and assisting the Quality Head as needed.
Responsibilities:
+ Ensure compliance with Good Distribution Practices (GDP) and Good Manufacturing Practice (GMP) and other relevant regulations for the import of pharmaceutical products.
+ Support the Quality Head in implementing and maintaining the quality management system for imported products.
+ Conduct batch verification and release of imported pharmaceutical products in compliance with Israeli regulatory requirements.
+ Assist in the investigation and management of Non-Conformances (NC) and the development and implementation of Corrective and Preventive Actions (CAPA).
+ Evaluate and approve temporary exportations as required, ensuring adherence to quality standards.
+ Review and maintain documentation relevant to import activities, including import permits, batch records, and quality reports.
+ Conduct supplier evaluations and audits to ensure compliance with quality and regulatory requirements.
+ Participate in internal audits and facilitate inspections by regulatory authorities.
+ Provide training and support to staff regarding quality assurance protocols and regulatory compliance specific to imported products.
+ Integrate and lead processes in the quality department such as handling customer complaints, conducting quality audits for suppliers, managing changes and deviations, updating procedures, and performing risk management.
+ Work with various stakeholders both domestically and internationally.
+ Participate in global projects related to quality.
+ Stay current with changes in regulations and ensure the company adapts accordingly.
**Qualifications**
+ Bachelor’s degree in Pharmacy from an accredited institution.
+ QP certification recognized by the Israeli Ministry of Health.
+ A minimum of 2 years' experience in the pharmaceutical industry as QP and Quality Assurance background.
+ Strong knowledge of Israeli pharmaceutical regulations and standards regarding import and global relevant regulations and guidelines.
+ Excellent analytical and problem-solving skills.
+ Strong attention to detail and commitment to quality.
+ Exceptional communication skills in both English and Hebrew.
+ Ability to work collaboratively within a team and independently as required.
+ Ability to work in different computer programs.
+ Education:
+ Bachelor's degree in Pharmacy (BPharm) at least from an accredited institution.
+ QP certification with necessary training and qualifications as required by the Israeli Ministry of Health.
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