Quality Assurance & Responsible Pharmacist Person

Zentiva
Hybrid
Regular employment
2 - 15 years of experience
Full Time
Sofia, Bulgaria
Responsibilities
Be a part of the winning culture!
At Zentiva, we are a team of 5,000 unique talents bonded together by our common mission. We believe our diversity is a source of great energy and strength, and we create a work culture and ethics where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking a balanced team across the company we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love.
Quality Assurance & Responsible Pharmacist Person
Currently, we are looking for a Quality Assurance & Responsible Pharmacist Person to join our highly motivated and inspired team in Zentiva Pharma Bulgaria.
The position combines Quality, focusing on maintaining the quality system in compliance with Good Distribution Practice and the corporate quality management system(QMS), and Responsible Pharmacist, a role that includes ensuring regulatory compliance, overseeing drug distribution, quality control and documentation, managing deviations and inspections, as well as liaising with health authorities.
What Would Be Your Main Responsibilities
- Fulfill the requirements & responsibilities of a Responsible Pharmacist, as described in the local legislation
- Control over the quality of goods received at the warehouse
- Form a package of documents on the quality of medicines sent to clients
- Is responsible for interaction with local Health Authorities for product-quality matters
- Is responsible for local Quality system set up and further lifecycle management according to local legislation and company standards
- Is responsible for local GMP/GDP license lifecycle management
- Is responsible for GMP/GDP training of the local team
- Is responsible for Annual Quality Review execution and management
- Is responsible for GDP release to the distribution chain
- Is responsible for internal / external inspection management
- Is responsible for vendor qualification and further management
- Is responsible for regular PQRs review by MAH (if applicable)
- Is responsible for deviation execution and management
- Is responsible for complaint execution and management, incl. suspected falsified medicinal products
- Is responsible for CAPA execution and management
- Is responsible for risk and product alert management
- Is responsible for returns management
- Is responsible for recall execution and management in cooperation with manufacturer/MAH
- Is responsible for local subcontractors quality oversight
- Is responsible for Quality assessment of product relating variations if applicable
- Is responsible for qualification of customers within distribution chain
- Is responsible for the management of the process of destruction of the drugs after exp. date and/or medicines with quality deviations
- Participate in carrying out inventories
We Need You To Have:
• Masters’ degree in Pharmacy
• Proven experience as a master pharmacist for at least 2 years
• Certificate of clean court record
• Experience with all applicable legislations and local regulations
• Good knowledge of QMS and other associated quality systems
• Ability to prioritize projects, strong sense of urgency and excellent problem-solving skills
• Must have excellent interpersonal skills and communication skills, written and oral, in Bulgarian & English
• Profound knowledge of MS Office (SAP, eDMS and QF are an advantage)
• Sound organizational skills
• Must be able to multi-task
• Reliable and trustworthy
• Flexible mindset, reliable team player and high sense of loyalty
It is crucial for us to have satisfied employees. Therefore, we can offer you the following:
Competitive salary;
Additional benefit package;
International working environment and a passionate team of professionals;
Continuous Learning & Development opportunities thanks to our Zentiva Academy;
A hybrid form of work - on-site & off-site.
Diversity is a fact. Inclusion is an act @Zentiva
At Zentiva, we are a team of almost 5,000 unique talents bonded together by our mission to deliver high-quality medicine to people whose lives depend on it. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. Join our winning team! Be a part of our winning culture! Be Zentiva.