Specialist, Quality Operations – GMP/GDP

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture
Site: www.ptcbio.com

Location: Vinhedo (Sao Paulo)

JOB SUMMARY

The Specialist, Quality Operations – GMP/GDP supports Quality Assurance (QA) activities related to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance for Clinical and Commercial products This involves working with cross-functional internal teams; Supply Chain; Technical Operations; Regulatory Affairs; Contract Manufacturing Organizations (CMOs) and Distribution Partners to implement, manage, maintain, and support quality assurance activities, including plans that contribute to the PTC ability to achieve and maintain regulatory compliance and ensure product quality for Clinical and Commercial Supplies/Named Patient Supply. He/she supports the activities of PTC's WDA Authorizations in Brazil. The incumbent supports batch disposition activities as required.

The incumbent works cross-functionally with internal departments and external resources on Quality related issues.

The Specialist, Quality Operations – GMP/GDP supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

• Act as a technical responsible, including QA oversight and QMS support, of Brazil Warehouse located in Vinhedo, São Paulo

• Perform Local QA disposition of products received in Brazil WH

• Performs QA review of documentation of contract manufacturing, packaging, labeling, and analytical records, as well as other related

• documents as required by GMP regulation for Commercial Supplies for products distributed globally as part of Batch record review team

• Performs QA review and approval of documentation related to contract storage sites, distribution partners and transportation providers including but not limited to:

  • Distribution Instructions (SOPs).

  • Investigations, incidents, exceptions, deviations and risk assessments as generated by contract storage sites, distribution partners and transportation providers.

  • Support Transport Validation in LATAM region and evaluation of temperature excursion during shipments in the region

• Resolves queries with CMOs/Distribution Partners in a timely manner, escalating issues to line management as required.

• Logistical complaints/vendor complaints.

• Evaluation of temperature excursions in accordance with SOPs.

• Ensures the successful submission of required paperwork, releases, and other related documents to PTC partners for Commercial/Named Patient Supply product.

• Contributes to the conduct of the Customer Approval/re-validation process. This includes supporting the Responsible Person (RP) in preparing the required documentation.

• Supports Batch Disposition activities as required, including maintaining QA trackers databases related to Batch Disposition.

• Provides support to QA for complaints, logistical investigations, APQR's etc.

• Contributes to the management of the Change Control System by generating and reviewing Change Control documents for Clinical and Commercial product.

• Liaises with, and effectively interfaces with, internal and external peers in the execution of assigned functions and regulatory compliance for Clinical and Commercial Supplies.

• Recommends QA system changes to enhance overall job performance and QA functions pertaining GMP/GDP systems.

• Maintains electronic and paper-based documentation, as needed

• Performs other tasks and assignments as needed and specified by management

REQUIREMENTS

• Reside near Vinhedo and be available to work on-site there on a daily basis

• Bachelor's degree in Pharmacy. Registration at Regional Pharmacy Council Advanced (CRF-SP) is required

• Experience in Quality Assurance or similar positions within the pharmaceutical, biotechnology, or related industries, along with experience in a Technical Responsible role.

• Detailed/Demonstrated knowledge and understanding of GMP/GDP regulations requirements.

• Demonstrated proficiency of commercial and clinical batch record review and experience of working with Contract Manufacturing organizations/Contract Storage Sites/Distribution Partners/Transportation partners.

• Fluent in English (verbal and written), Spanish is desirable.

• Experience in Quality Management Systems including Deviation Management, Out of Specifications, Change Control.

• Proficiency with Microsoft Office.

• Excellent verbal and written communication skills.

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

• Experience in ERP systems.

• Validation/manufacturing experience.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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