Manager -Validation ,Vibonum Technologies ( Pharmaceutical)

Role & responsibilities:

• To handle cleaning validation activities. (MACO calculation, product and equipment matrix preparation, grouping, sampling location/ analytical method updation 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