QA Associate
Job Description:
A full time Quality Assurance Associate to manage the documentation center and to review GMP records to ensure completeness, accuracy, and compliance with SOPs/regulations.
Requirements:
Duties & Responsibilities
Review executed batch records and associated documentation for product clinical and commercial disposition.
Review deviations, CAPAs, and change controls related to manufacturing operations
Review and approve SOPs, specifications, forms
Review executed protocols and validation reports
Maintain spreadsheets for tracking data used in reporting metrics
Assist with review of master batch production records and validation protocols
Provide support during regulatory audits
Manage the Documentation Center
Provide support to other QA functions as required.
Education
B.Sc or M.Sc in a science related field such as biology, Pharmacy, chemistry, biotechnology etc.
Work Experience
At least 5 years of experience in a GMP pharmaceutical company, preferably at commercial stages.
In-depth knowledge of the Regulations with regard to commercial stage cGMP
Experience in applying QA systems, deviations and OOS investigation, CAPA management and risk assessment is a must
Management and oversight of CMOs is an advantage.
Skills
Working knowledge of cGMP is required.
Ability to interpret and apply ICH guidelines, regulatory guidance, and other pharmaceutical standards is required.
Experience in batch records review as part of batch release is a must
Knowledge and application of good documentation practices
Excellent interpersonal, verbal and written communication skills in English
Solid computer skills using Word, Excel, and PowerPoint
Languages
English at mother tongue level
Personal Qualities
High attention to details and adherence to standards are required.
Team player with the ability to work collaboratively with other functional area staff gaining their cooperation in dealing with issues of compliance.
Proven ability to work effectively in a fast paced team environment
Efficient organizational skills, including the ability to manage multiple tasks and priorities effectively
Must stay current with relevant technologies and forward thinking to identify new approaches.
