Job ID: 54804- Location: Jacarepaguá, BR- Job Level: Entry Level- Job Category: Sales and Marketing- Employment Type: Permanent position- Career Level:
Headquartered in Lachen near Zurich, Switzerland, the Octapharma Group is a leading company in the worldwide market for therapeutic human proteins.
Working at Octapharma means to have an opportunity to contribute to our common goal - developing lifesaving therapies to improve patients' lives.
**Location: Brazil, São Paulo**:
***Position: Regulatory and Blood Banks Analyst**:
***Your role**:
A highly motivated and experienced professional to join and lead the Regulatory and Blood Banks Management team in Brazil.
This position will also assume 3 main role positions, namely, Qualification of Blood Centers including its monitorization, serve as liaison for the plasma collection supporting in the logistics coordination and finally assist the Regulatory Department at Octapharma Brazil.
Your main responsibilities and opportunities
- Relationship with Hemorrede (Blood Centers network):
- Qualification of blood centers:
- Organization of documentation of qualifying blood centers, as well as collection of missing documents and monitoring the documents expiration
- Keep process indicators up to date
- Monitoring of the audit plan and communication with the corresponding audit service provider
- Audit reports translation
- Characterization of the Hemorrede regarding infrastructure and valence; tabulation of the information contained in the questionnaires prior to the audits;
- Completion of the form and other diligence leading to the qualification of services
- QAA - implementation and signature of the Quality Agreement and its annexes
- Audit findings monitoring and verification of submission of evidence according to the deadline established in the CAPA
- Participation in meetings between national and international teams
- Plasma Collection Logistics:
- Relationship with the service providers
- Support in the organization and scheduling of plasma collections at Blood banks
- Control of necessary inputs for plasma collection
- Organization the collection documentation and upload of records in correspondent platforms
- Monitoring and plasma documentation checking
- Management of previous monthly amounts of collection in each blood center
- Hemorrede management and monitoring:
- Periodic technical visits to blood centers: developed processes monitoring, verification of needs and improvements
- Actions proposals that make possible to increase the number of bags collected monthly
- Regulatory:
- Preparation and submission of the Brazilian Plasma Master File
- Maintenance of regulatory documentation inherent to the qualification of blood centers (see 1.a)
- Identify new regulatory legislation and its updates related to the Hemotherapy area
**Your expertise**:
- 1/3 years in similar function
- Pharmaceuticals degree
- English - excellent written and oral skills.
- Good grasp of pharmaceutical and biotechnological concepts;
- Solid knowledge of Regulatory Affairs of biological drugs;
- Good command of eCTD
- GMP and GDP regulation
- Highly motivated, Analytical; Independent; Methodic
- Team-worker
- Self-starter; effective in a highly dynamic environment where priorities can change rapidly
**What we offer**:
- Develop and grow a professional career in an exciting, challenging and international environment.
- You will have a high level of influence where you can make a difference and leave your footprint.
- Be rewarded with an attractive salary and benefits package.
- Work with skilled and fun colleagues.
***How to apply**:
**Working at Octapharma**:
Whether your interests lie in the field of research and development, production, marketing, sales, finance or engineering, there are many career opportunities at Octapharma
We are the world's largest family-owned plasma company and entirely European.
In the spirit of our founder Wolfgang Marguerre, we do not pursue short-term profit goals, but have future generations in mind.
Our vision: we are passionate about developing new healthcare solutions that improve lives.
We own 6 modern production facilities in Austria, France, Germany, Sweden and Mexico.
The Marguerre family continues to play an essential role in the company's day-to-day operations.
Octapharma wants to offer its employees a working environment that challenges them as much as it enriches them.
Since its foundation in 1983, the company has grown steadily and today we employ almost 10,000 people.
**About Octapharma**:
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs around 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care.
Octapharma has seven R&D sites and five state-of-the-art