
Pharmaceutical Quality Assurance Specialist
5 days ago
We are seeking a skilled Quality Assurance Professional to join our team. This role will be responsible for ensuring the quality of our products and processes.
Job Summary:This position involves reviewing and approving batch records, logbooks, and controlled documents. You will also oversee line clearance, in-process checks, and QA compliance. Additionally, you will lead and investigate deviations, OOS, OOT, change controls, and CAPA.
Key Responsibilities:- Review and approval of batch records, logbooks, and controlled documents
- Oversee line clearance, in-process checks, and QA compliance
- Lead and investigate deviations, OOS, OOT, change controls, and CAPA
- Coordinate with production, QC, and engineering for quality compliance
- Handle document control, issuance, archival, and retrieval systems
- Support vendor qualification and raw material quality compliance
- Prepare for and participate in internal audits and regulatory inspections
- Bachelor's or Master's degree in Life Sciences, Chemistry, or a related field
- 4-8 years of QA experience in a pharmaceutical manufacturing unit
- Strong knowledge of QMS, regulatory compliance, and cGMP
- Experience in facing audits (USFDA/WHO/other regulatory bodies is an advantage)
- Excellent analytical, communication, and leadership skills
This role offers a competitive salary and opportunities for professional growth and development.
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