Quality Assurance (QA) Manager

Bucureşci - Romania

Monthly Salary: Not Disclosed

Posted on: 1 hour ago

Vacancies: 1 Vacancy

Job Summary

As the creator and leader of the global partnership category in the pharma industry we strive to be Always Ahead and work relentlessly to bring therapy to patients in need no matter where they live.

Our values are at the core of every action we take and we are committed to going above and beyond for the benefit of the patients we serve.

We are a dynamic fast-paced company operating in over 34 countries across 5 continents. We are looking for out-of-the-box thinkers people who are passionate caring agile and adaptive to join us on our mission. If you are looking to make a difference in peoples lives we invite you to join us!

As QA Manager for Central EPM (European Partner Markets) youll be a key player in safeguarding quality across multiple European markets ensuring our operations meet the highest regulatory standards and drive continuous improvement.

Responsibilities:

The Quality Assurance Manager Central EPM is an experienced professional and part of European Partner Markets (EPM) QA team. Based in Romania as part of the Central Cluster the QA Manager is supporting a number of territories and will report directly to the Head of QA EPM. He/she will play a vital role in the Region as well as actively participate in the EPM Quality Team.

Areas of Responsibility

Participate in designing implementing maintaining and improving the quality system. Ensure the QMS is compliant to regulatory requirements
This role will not only cover the Central Cluster: Romania (Moldova) Hungary Czech Republic Slovakia but can be extended to other territories
Independently initiate and approve SOP updates and creation of new SOPs. Additionally oversee review of SOPs and associated documentation to ensure review requirements are met
Provide hands on quality expertise to colleagues and partners to support their quality and business needs
Participate in vendor management program vendor oversight QTA generation and auditing including lead auditor role to evaluate partner/vendors Quality Management Systems resources premises and equipment
Work with QA Director to ensure Medison is compliant with latest regulatory and pharma trends related to GMP and GDP
Ensure/participate in self-inspections of Medison GMP/GDP operations are performed to schedule and identified CAPAs are closed to plan
Participate in Medison Management Review to assess the effectiveness of the QMS and to highlight continuous improvements as appropriate
Ensure change control requests deviations complaints and CAPAs are reviewed using risk-based principles to comply with applicable requirements
Participate in regulatory inspections and supplier audits as required
Participate in recall and mock recall operations
Carry out any other duties that may be reasonably required and assigned to you by your manager

City:
Bucharest

Requirements:

Required Education and Experience:

Masters or Bachelors Degree in science or equivalent
At least 5 years experience in an active QA role
Excellent written and verbal communication skills
Fluent English is essential
Attention to detail
Quality function representative on various projects
Root cause analysis and investigation skills
Technical report writing
Strong knowledge in regulatory GDP and GMP requirements
Proven track record in auditing and quality systems
Experience in regulatory inspections is desirable
Strength in critical thinking problem solving and decision making
Collaborative nature self-directed and independent
Very strong organizational abilities
Auditing experience

Required Qualifications:

Excellent interpersonal skills and ability to successfully maintain professional and trusting relationships
Works effectively in highly dynamic and changing environments displays agility
Willing to travel locally and internationally as needed
Ability to work with anyone (flexible personality) horizontally and vertically across the organization with a demonstrated ability to interact professionally to influence and to manage conflict/differing opinions with the ability to drive solutions
Be a quick learner with strong work ethics
Be pragmatic with a drive for results
Ability to identify and understand issues problems and opportunities whilst providing a viable solution
Able to work in a fast dynamic environment whilst being able to adjust readily to meet unexpected constraints.

Medison offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry we strive t...