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This position will provide QA technical support for External Manufacturers in Latin America. Assist in the development of corrective action plans and monitor implementation. Assist in the development, writing and implementation of quality procedures. Provide QA support for technology transfer and improvement of existing manufacturing processes. Contribute to the overall development, implementation and execution of quality systems in support of the manufacture of pharmaceutical products. Conduct investigations, perform customary audits, collect data, analyze trends, and prepare reports as required.
ESSENTIAL FUNCTIONS:
- Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time.
- Monitor trends, identify issues, recommend and implement appropriate actions.
- Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.
- Coordinate and provide concurrences on deviations.
- Position requires occasional travel to External Manufacturer’s sites to provide cGMP assistance andquality oversight. Minimum 30%.
- Participate and Lead audits of External Manufacturers.
- Assists with regulatory inspections and provides follow up on regulatory commitments.
- Develop, implement, and review of SOPs for interactions with External Manufacturers.
- Investigate customer product quality complaints.
- Coordinate change control documentation and approval process.
- Provide Quality oversight and participate on technology transfer teams.
- Interface with other functions (Operations, Planning, Technical Operations, etc) in the support of External Supply Integration.
ADDITIONAL RESPONSIBILITIES/DUTIES:
- Providing support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and international manufacturing.
- Remaining current with ANVISA and local regulations, guidelines, and quality practices associated with the pharmaceutical industry is required.
- Computer literate well versed in Microsoft Office tools with the ability to communicate effectively electronically.
- Continued development of knowledge and expertise as needed in order to perform job duties.
- This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
**Qualificações**
EDUCATION and/or EXPERIENCE:
Bachelor’s Degree with a minimum of 8 years in a ANVISA/LATAM regulated environment is required; preferably in a pharmaceutical / biologics manufacturing or quality environment. Advanced degrees are a plus and may reduce the experience required. Demonstrates knowledge of Quality Assurance, Quality Control and Compliance. Experience in the development, implementation and review of SOPs for interactions with contract manufacturers is preferred.
Position requires a minimum of 30% travel to external manufacturing sites.Demonstrates skills in the following Global Leadership areas: Integrity and Credo Based Actions, Sense of Urgency, Results and Performance Driven, Collaboration and Teaming and Prudent Risk Taking.
**Local Principal**
Brasil-São Paulo-São José dos Campos-Rod.Presidente Dutra, Km 154
**Organização**
Janssen Cilag Farmaceutica Ltda. (7585)
**Cargo**
Qualidade
**Requisition ID**
2206020270W