Specialist (m/f/d) Cleaning Validation Pharmaceuticals
at
THESAY PHARMA
Berlin, Berlin, Germany
-
Full Time
Start Date
Immediate
Expiry Date
20 Nov, 26
Salary
0.0
Posted On
22 Aug, 26
Experience
0 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Industry
Pharmaceutical Manufacturing
Description
Independent planning, execution and careful documentation of cleaning validations on production facilities and media systems, especially in the field of solid dosage form manufacturing.
Continuous development and adaptation of the cleaning validation concept, taking into account current regulatory requirements, new guidelines and internal specifications.
Calculation of PDE (Permitted Daily Exposure) values and participation in the evaluation of new starting materials as well as maintenance of the associated overview documents.
Cooperative coordination and close collaboration with interdisciplinary teams from production, laboratory, engineering and other participating departments to coordinate and prepare validation measures.
Creation and execution of sound risk analyses with subsequent initiation and monitoring of suitable measures to ensure compliance and quality standards.
Proactive handling and coordination of the resolution of deviations that occur during validation activities, including the implementation of corrective and preventive actions.
Support with process validations in the operational area and ensuring GMP compliance throughout the entire production process.
Creation and continuous updating of standard operating procedures (SOPs) and conducting appropriate training for employees to ensure the implementation of validation requirements.
Competent presentation and explanation of cleaning validation documents during customer and regulatory audits to ensure transparency and traceability.
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