QA Specialist II (Validations)

At PCI, we believe our employees are our most valuable asset. Therefore, we are committed to offering a benefits package designed to support your well-being and improve your quality of life.

• Competitive salary.

• Health insurance + medication reimbursement.

• English classes.

• Discounts on various activities.

• Gym partnerships.

• Referral program.

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

As a QA Specialist (Validations), you will play a key role in ensuring compliance with the highest quality standards and GMP regulations in our pharmaceutical operations. You will work cross-functionally with Production, Engineering, Quality Control, R&D, and Regulatory Affairs teams, participating in qualification, validation, and continuous improvement activities. You will be responsible for ensuring that processes, equipment, and systems meet regulatory requirements, contributing to the release of safe, high-quality products, as well as the success of audits and inspections.

• Prepare Standard Operating Procedures following GMP regulations.

• Implement and verify the application of GMPs.

• Issue and review Manufacturing Guides, Analysis Certificates, Stability Bulletins, and documentation associated with manufacturing campaigns, making the final decision on the approval or rejection of manufactured batches.

• Collaborate in the preparation of technical documentation related to manufactured products (dossiers, quality agreements, specifications for starting materials, intermediate products, and finished products, etc.).

• Collaborate in the qualification and validation of equipment, systems, and cleaning, as well as supervise and approve the validation of processes, analytical methods, and stability studies.

• Prepare quality reports and annual Product Quality Reviews (PQR).

• Approve R&D and Regulatory Affairs Department proposals related to product quality.

• Participate in customer audits, perform internal quality audits, and evaluate and approve suppliers, including external audits.

• Manage document control, data and record archiving, labeling control, and verification of finished product shipments.

• Manage CAPAs, deviations, out-of-specification (OOS) results, customer complaints, and change controls related to processes, facilities, and analytical methods.

• Analytical skills.

• Attention to detail.

• Rigorous document management.

• Planning and organization.

• Ability to work in multidisciplinary teams.

• Ability to manage several qualifications simultaneously.