Pharmacist as Responsible Person based in Sofia
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.