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 serviceproviders
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
PLEASE APPLY ONLINE IN ENGLISH DESCRIBING YOUR INTEREST, AND ENCLOSING YOUR CV, REFERENCES AND/OR RECOMMENDATION LETTERS TO:
