Manager - Cleaning Validation (OSD), Mysore

Job Description

Role & responsibilities: To handle cleaning validation activities. (MACO calculation, product and equipment matrix preparation, grouping, sampling location/ analytical method updating in software as well as manually. Preparation of cleaning validation, cleaning verification, cleaning study protocols and report compilation. Evaluation of newly introduced equipment/product with respect to cleaning validation master plan (Bracketing) for cleaning validation and cleaning verification requirements. Various cleaning study execution with respect to change in cleaning agent/cleaning procedure. Annual Cleaning process review report preparation for evaluation of cleaning process/ Change Control/ Deviation/ New product introduction/ New equipment introduction not limited to. Protocol preparation, execution and report compilation of DEHT/CEHT/recovery study for various equipment and to evaluate gap assessment in cleaning validation SOP. To support Process validation and Hold time study activities Execution in duct cleaning validation/ verification activities with CFT Identification of Hard to clean locations of equipment with production team. Identification of worst case products and calculation of swab limits. Determination of Visual residue limit by protocol based study. To involve in investigations / failures related to cleaning methodologies. Preferred candidate profile: Well-versed with Cleaning Validation activities in OSD mfg. site. Sharp in Documentation and Review of shopfloor data Good communication and interpersonal skills EU/ TGA/ ANVISA regulatory audit exposure is an advantage Good knowledge of European agency guidelines Sound knowledge of ALCOA+ concepts and able to identify gaps w.r.t. ALCOA+ principles if any at shopfloor operations. Strong analytical and problem-solving skills Attention to detail and ability to work under pressure Knowledge of the local language (Kannada) is an added advantage Perks and benefits: Best in industry