Essential Skills and Experience:
- Experience in reviewing and approving validation documents (test plans, protocols, reports, etc.) to ensure compliance with internal procedures and regulatory requirements.
- Ability to make validation documents understandable and defendable during inspections.
- Experience in supporting site project validation activities and ensuring all cGMP regulatory requirements are met.
- Familiarity with method verification protocols, SOP and worksheet, execution of protocols, and methods reports.
- Experience with Bio burden, Endotoxin, Growth Promotion, Identification, Identity – HPLC, ID-Osmolality, Material Appearance, Osmolality, Solubility, Sterility.
- Experience in validating assays.
- Knowledge of the current ISPE Baseline Guidelines for Commissioning and Qualification and GAMP5.
- Experience in drafting validation protocols and reports.
Desirable Skills and Experience:
- Experience with Kneat and Paperless Validation Software. (Plus)
- Experience Drafting Validation Protocols and Reports (MUST)
- Experience with Assay's (MUST)
