Educational Qualifications:
• BS preferred in a scientific discipline e.g. Biology, Chemistry, Biochemistry, etc.

 

Required Experience:
• Minimum 3 years of relevant experience performing pharmaceutical GMP quality assurance responsibilities. Additional previous development or production experience will be a great plus.

 

Essential Functions/Responsibilities:
• Working knowledge and understanding of current Good Manufacturing Practices with 21 CFR Part 210 & 211 and ICH Q7 Guidance.
• Proven ability to revise and update SOP's and policies to comply with regulatory requirements.
• Maintain document control and training programs.
• Capable of reviewing quality system-related records e.g., deviations, change control, CAPAs, incidents, and OOS investigations.
• Support both internal and external inspections/audits.
• Provide quality support to ensure regulatory compliance with the GMP production and analytical labs, vendor qualification, facilitating necessary equipment/instrument qualification and validation activities.
• Collaborate with other QA team members and cross-functional stakeholders to provide input to support GMP activities/projects.
• Perform quality review of material and product disposition documents, batch production-related records, analytical/QC-related testing records, protocols, and reports.
• Participate in continuous improvement efforts and implement changes for improvement.
• Perform other activities as assigned by the QA head.
 

Job Type: Full-time
 

Qualifications:
PhD in Organic Chemistry and 1 year of experience in chemical process development and manufacturing; or MSc in Organic Chemistry with 5 years of relevant experience. Must have experience in chemical process safety protocols, and state-of- the-art analytical techniques of organic molecules including NMRs, LC-MS’s, GC/MS’s and Gaussian molecular modeling.

Send application to Human Resources at HR_USA@pharmablock.com and reference code #97.