Regulatory Affairs and Quality Analyst

6 meses atrás

Rio De Janeiro, Brasil Octapharma Tempo inteiro

Job ID: 57720- Location: Jacarepaguá, BR- Job Level: Professionals- Job Category: Regulatory Affairs- Employment Type: Permanent position- Career Level:
Do you want to combine the opportunities that a global company provides with the benefits of a family-owned business? 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.

**What's the best thing about working with us?**:

- You help save lives - Every day is meaningful as we produce life-saving medicines
- Family values - Long-term perspective for employees and relationships
- Be rewarded with an attractive salary and benefits package
- You will have a high level of influence where you can make a difference and leave your footprint
- Work with skilled and fun colleagues in a relatively informal organization
- Skills development - We offer various internal and external employee and leadership trainings, trainee programs and digital solutions

***What will you be doing as Regulatory Affairs and Quality Analyst?**:

- Support in the preparation of regulatory dossier for submissions of product registration, post-registration, registration renewals and HMPs at Anvisa
- Assist in maintaining valid the GMP granted by Anvisa of all Octapharma and all diluent suppliers’ sites
- Review packaging materials based on local legislation and according to Octapharma Guidelines
- Support pharmacovigilance activities in Brazil, including the receipt, communication and treatment of adverse events in accordance with Brazilian legislation
- Complaints and Recalls: support in handling of all quality and service deviations, according to Brazilian legislation and Octapharma internal procedures
- Develop and/or update SOPs; Train the team, as needed

**Who are you?**:

- Bachelor´s degree In Pharmacy
- Advanced English
- knowledge of Anvisa's regulations for biologic products
- Good written and verbal communication skills and interpersonal
- Analytical profile focused on results and deadlines

**The Regulatory Affairs Department**:
Octapharma's Regulatory Affairs Department (Brazil) is dedicated to ensuring compliance with Brazilian and global regulatory requirements in the development, manufacturing, and distribution of products based on human proteins. The overall responsibility of the Regulatory Affairs department is to secure approvals for new products, variations, and manufacturing changes, while also maintaining compliance with existing regulations.

**If you proceed in the process**:

- We will endeavor to review your profile as quickly as possible and provide you with feedback
- The next step is to conduct a phone interview, which takes about 30 minutes.

Would you like to get to know us better? Learn more about us on our website and follow us daily on LinkedIn

**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 nearly 12,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care.

Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 195 plasma donation centres across Europe and the US. Octapharma has 40 years of experience in patient care.

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