Job Description
This vacancy is a great career opportunity concerning a new pharmaceutical manufacturing facility associated with a European group. Role description: ● Responsible for planning, scheduling, executing, and leading various validation project assignments. The validation assignments include designing, development, validation, qualification, and implementation of the facility, products, utilities, equipment, processes, instrumentation systems, etc. ● Coordinate and interface with the process unit heads, support FATs, SATs, IQ, OQ, PQ, CV, and PV as appropriate for the plant, equipment, systems, and processes review documentation and advise team members to deliver best practices, contribute to the overall validation strategy, prepare and maintain a site Validation Master Plan (VMP), establish and maintain system lifecycle documentation, generate or approve. ● Prepare quality risk assessment documents, and do any other duties as assigned in accordance with the needs of the department and company. ● Report directly to the board of directors and matrix report to the engineering validation senior group manager. Factory Location: Kordan, 10 Km of Karaj-Qazvin freeway, Alborz.
Requirements
● Bachelor’s degree in related Engineering fields. ● At least 5 years of leading and conducting validation activities in a GMP licensed facility. ● Good understanding of Quality Management Systems and having a controlled approach to identifying and reporting deviations and completing CAPAs. ● Proven experience in managing compliance to GMP regulations and guidance including specifically Annex 11 and 15. Current working knowledge of GMP, and a deep understanding of validation of cleanroom manufacturing environments and related equipment. ● Experience in validating a new GMP manufacturing unit will be a considerable asset. ● Experience in participating in the introduction of new processes and equipment into a GMP manufacturing facility will be a considerable asset. ● Experience in interaction with regulatory bodies and development of audit responses preferred. ● Able to apply a risk-based approach to operation and interpretation of resulting data. ● Previous work experience in managing people is a must. ● Strong decision-making skills and a results-driven approach. ● Fluency in English is a must. ● Strong computer proficiency. ● Ability to travel for short-term and medium-term duration trips is also a necessity. If you are interested in this offer, please send us your English CV.
Employment Type
- Full Time
Job Category
Seniority
Details
Employment type
- Full Time
Job Category
Seniority
