The Purpose of this job is to execute process validation activities to meet GMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations. The role involves providing technical expertise (and may facilitate) pre-validation risk assessments using risk management tools and manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence. The person will be responsible for providing technical expertise and recommendations for validation of major or complex changes in manufacturing. The person will author and review process validation protocols (e.g. launches, weak point remediation) and related reports.
Validation Expert (50%)
Global pharma company
Are you looking to work in a global growth company where you can make a real difference? Then you are right with us!
BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology
As per Industry
The candidate must have 2-3 years experience in manufacturing/manufacturing science and technology/technical development/quality. The person needs to have a thorough understanding of Biotech (mammalian cell based) manufacturing processes and related process equipment. Experience in biotech process validation or biotech cleaning validation (plan and Report writing) is needed. Experience in biotech process validation or biotech cleaning validation (plan and Report writing) is desired.
Deutsch: Sehr gut
Englisch: Sehr gut
If you are interested then kindly send your resume to: firstname.lastname@example.org