Want to know if this job is worth applying to?
București, România
Hybrid
Job Description Summary
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.Job Description
For our Quality Assurance team, we are looking for a Quality Assurance Specialist, based in Bucharest, whose main responsibilities will be to:
Major accountabilities:
Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance and follow up the corrective actions.
Coordinate implementation of quality system and procedures for the implementation of Sandoz Quality Manual and quality agreements.
Ensure that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Sandoz Quality Manual and Policies and meet all relevant cGMP regulatory and local legislative requirements.
Support launches of product in close collaboration with BD&L partner and / or development organization.
Ensure that a local Quality System and Standard Operating Procedures are in place for all cGMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits. Identify repetitive activities and regulatory areas for which SOPs are required.
Ensure that Change requests, are managed according to the Sandoz SOPs from receipt, through to the implementation and closure. Ensure that an effective Change Control process is in place.
Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.
Ensure that all incoming drug products are inspected prior to release to the market in accordance with the current in place procedures, registered specifications and with local/international regulations.
Manage complaints, recalls, counterfeits, product tampering and any other quality issues (deviations, escalations, quality events, stability failures, etc.) according to the Sandoz Corporate Quality Manual and internal written procedures. Ensure that investigations are correctly executed and all required actions are taken appropriately and in a timely fashion.
Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt
Distribution of marketing samples (where applicable)
Minimum Requirements:
University degree in Pharmacy
Minimum one year of practical experience in activities related to the handling, storage, and distribution of medicinal products or in trading activities related to the procurement or sale of medicinal products
Possess knowledge in the field regarding Law No. 95/2006, republished, as subsequently amended, the Guidelines on Good Distribution Practice of medicinal products, approved by Order of the Minister of Health No. 761/2015, and any other legal acts related to distribution activities
Collaborating across boundaries
Operations Management and Execution
Continuous Learning
Dealing With Ambiguity
Self-Awareness
Languages:
English - proficient level
You’ll receive:
Beside your well positioned salary in the market and your specific working tools:
Various benefits for holiday, Christmas, Easter and other occasions
Dental & ophthalmological benefits
Monthly sport benefit
Extra vacation days
Medical & life insurance
Meal tickets
Learning opportunities
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
#Sandoz
Skills Desired
Continued Learning, Dealing With Ambiguity, Good Documentation Practice, Guideline, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Regulation, Self-Awareness, Technological Expertise