Pharmacist as Responsible Person based in Sofia

Regulatory Affairs/Clinical Affairs Sofia, Bulgaria


Descripción

Responsible Pharmacist based in Sofia

At Perrigo our mission is clear: To make lives better by bringing Quality, Affordable Self-Care Products that consumers trust everywhere they are sold.  With over $5.5 billion in sales and more than 10,000 employees working around the world, Perrigo Company is a leading global self-care supplier.

Mission of the role:

Reporting to Director RA, QA, Safety – Central East Europe, the Responsible Pharmacist is to assure the high quality of our operations and services aiming to the long-term success of our business.

We are looking for a Responsible Pharmacist to ensure that all external and internal requirements are met before our products reach our customers. The ideal candidate is a reliable and competent professional whose approval will be necessary for the continuation of a business life cycle.

Responsibilities of the role include:

  • Fulfil the requirements & responsibilities of a Responsible Pharmacist, as described in the local legislation.
  • Maintain the Quality Management System supporting the distribution license linked into the GDP network / corporate quality systems as applicable. Share details of WDA and QMS and escalate any significant issues immediately.
  • Develop and maintain collaborative relationships with Ministry of Health, National Health Insurance Fund, Bulgarian Drug Agency, Regional Health Inspectorate and other related institutions as well as other companies and contractors.
  • Participate in the preparation and successful completion of first, second and third-party audits that are relevant to the pharmaceutical ordinance and good distribution practice.
  • Keep up-to-date required licenses for the Company's core business in accordance with current legislation.
  • Ensure the business remains compliant with the European and National legislative framework applicable to the products.
  • Ensure compliance with the Ordinance of medicinal products, medical devices, food supplements, cosmetics, biocides and their order in the warehouse.
  • Ensure MAH follows all the necessary processes and procedures to comply with all relevant regulatory requirements.
  • Provide full Regulatory / Quality support to the business pharma initiatives and current business including submission of new marketing authorization applications / notifications.
  • Being face of pharma operations in front of regulatory authorities, providing all the reports required by law.
  • Monitor all operations that affect quality.
  • Devise procedures to inspect and report quality assurance issues.
  • Manage any Quality or Safety issues.
  • Organize the acceptance, storage and dispensing of pharma products.
  • Control over the quality of goods received at the warehouse.
  • Control over balances and movement of goods in the warehouse.
  • Control over repackaging / rework of goods
  • Track the expiry dates of goods.
  • Form a package of documents on the quality of medicines sent to clients.
  • Participate in carrying out inventories.
  • Train the organization on pharma requirements as per global and local SOPs.
  • Control over import and export of goods and ensure compliance with relevant legislative, quality and custom requirements

 

Requirements for the role include:

 

  • Bachelor’s Degree in Pharmacy
  • Proven experience as a Responsible Master Pharmacist for at least 2 years in a multinational business environment
  • Experience with all applicable legislations and local regulations
  • Good knowledge of QMS and other associated quality systems
  • Proficient in written and verbal English
  • Commitment to providing excellent quality work and ability to meet tight deadlines
  • A confident and positive attitude, focused in teamwork and communication
  • High integrity
  • Live the company’s Values: Integrity, Respect, Responsibility. Act as a role model and make sure that everything doing is aligned with Perrigo’s values and for the benefit of our consumers.