Quality urance Specialist

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Job Description

The Quality Specialist is responsible for supporting the development and maintenance of the Pharmaceutical Quality System.

Additionally, this role will manage and oversee critical quality system elements pertained to supplier management, product dispositions, deviations, change control, CAPA and support Quality Management Review.

1. Support the day-to-day quality systems for all products.
2. Provide Quality oversight of clinical, commercial, distribution, and drug safety/pharmacovigilance activities.
3. Oversee Document Control, Deviations, CAPA, Change Control, Complaints, Training and Metrics.
4. Partner with Supply Chain, Regulatory Affairs, Tech Services and Management to ensure compliance with policies, procedures, and industry regulations.
5. Provide Contract Manufacturing Organization (CMO) Quality Oversight.
6. Support the evaluation of product quality complaints, investigations and associated CAPA(s) for potential reportable events.
7. Support third-party supplier/CMO investigations.
8. Facilitate the Document Control System.
9. Support the administration of eQMS system.
10. Facilitate the third-party change control system.
11. Support the development and Management of the training program.
12. Organize and present metrics for management review meetings and Quality Council.
13. Support internal and external audits as needed.
14. Assist as needed in the drafting of Quality Agreements.
15. Participate in internal and external meetings and site visits to ensure cGxP compliance.
16. Build relationships with Quality partners at CMOs to resolve quality issues in a timely manner.
17. Compile and provide documentation and responses to Regulatory and Compliance requests (GMP renewals, RA questions and submissions, observations, compliance gaps, audits).
18. Support the compilation of Annual Product Quality Reviews.
19. Engage in activities to continuously assess and improve processes.
20. Support the assessment, implementation, and management of Risk Management Program.
21. Other duties as required or directed by QA Management.
22. Support the Supplier Qualification program including, but not limited to: maintaining the Approved Supplier List in state of compliance, schedule, assign and conducts external audits, including issuing of audit reports and conducting follow-ups as appropriate.

Requirements

1. Bachelor s degree in a scientific discipline is preferred.
2. Minimum of 3-5+ years of progressive experience in a GMP environment required.
3. Minimum of 3-4 years of Quality Assurance experience in support of GMP production required.
4. Working knowledge of GMPs and their application to pharmaceutical manufacturing required.
5. Previous exposure to investigations and product complaints preferred.
6. Must be able to interpret applicable standards and objectively make decisions with support of management.
7. Must be proficient in MS Office Suite.
8. Experience in the use of Material Requirements Planning (MRP) systems preferred.
9. Excellent organizational and communication (oral and written) skills.
10. Experience with the application of GDPs within the pharmaceutical industry.
11. Familiarity with the manufacturing and packaging process of solid oral dosage and liquid drug products.
12. Experience working with external partners in a Quality Assurance capacity.
13. High level of flexibility and willingness to learn.
14. Ability to work in a high-paced, timeline driven corporate office setting.