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Pharmaceutical Associates - San Diego, CAPosition Responsibilities : Manage quality related activities for drug substances and drug products. Develop and maintain quality system to meet applicable regulatory requirements (e.g. FDA, EMEA). Maintain GxP compliance internally. Develop and maintain company SOPs, specifications and change control. Quality oversight of contract research organizations, including audits of analytical testing laboratories, drug substance and drug product manufacturers. Review batch records. Prepare for and participate in PAIs. Support in house GMP activities such as inventory, sampling and storage of GMP materials (samples, labels, API, drug product). Maintain employee training records and assures job specific training is provided and documented. Requirements : Bachelors degree (preferably in the life sciences)... See job listing >30+ days ago from Pharmaceutical Associates,LLC - Save - More Tools...
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