Job Details
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Job Description
- Develops and implements Quality Assurance processes and systems.
- Acts as custodian for various Quality Assurance processes (Change Control, Calibration, etc.) as assigned.
- Issues & reviews Standard Operating Procedures and various Quality related technical documents (protocols, specification, work instructions, batch records, etc.) in a highly collaborative environment.
- Conducts Quality Event investigations (Non conformance / failure, deviation, corrective actions preventive actions CAPA, etc.) and document in appropriate reporting methods and systems.
- Participates in internal Quality System / cGMP audits.
- Reviews batch documentation for correctness and completeness, and to release product for further processing or commercial trade.
- Reviews systems to assure that security and data integrity are maintained.
- Performs other duties as assigned.
Job Requirements
Skills & Qualifications:
- Bachelor degree of Pharmacy is a must.
- Fresh to 2 years of professional experience as a Quality Assurance professional in the pharmaceutical manufacturing industry (finished drug product or Active Pharmaceutical Ingredients / complex chemical processing).
- Must be able to demonstrate proficiency in verbal and written communication in English.
- Must be familiar with and competent in the use of Microsoft Word, Excel, and PowerPoint.
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