Validation Expert

  • Basis:  Full-Time
  • Closing Date:  02 Aug, 2020
  • Job Ref:  KMP-54238

Job Description

The Siegfried Group is a Swiss-based worldwide life science company which develops and manufactures active pharmaceutical ingredients, intermediates, standard controlled substances, and ready-formulated drugs. Forming part of the Siegfried Group, Siegfried Malta Limited specialises in a high-value and innovative generic portfolio in the solid dosage form range, from bulk to final packaging including capsule filling and high potent FDA approved products.

Position Summary
We are seeking to recruit a Validation Expert to lead the Process and Cleaning Validation team including projects and other related activities on site:

The chosen candidate will be responsible for:

  • Managing, developing and implementing validation processes to ensure products meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices;
  • Oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements;
  • Designs and conducts process validation activities for oral solid drug dosages (OSD) products
  • Leads process capability and statistical analysis of OSD manufacturing process;
  • Leads the assessments and approvals of validation strategies, control strategies and holding time studies for all products undergoing transfer and commercial manufacturing stages;
  • Prepares documented protocols and reports for validation exercises in compliance with corporate guidelines, procedures, FDA Regulations and industry current practices;
  • Lead the cleaning validation / verification program and activities including sampling

The ideal candidate should possess:

  • A bachelor’s degree in Life Science or other job related discipline
  • Proven validation experience in a leading position within the pharmaceutical industry;
  • Excellent analytical skills with systematic approaches to problem solving including the ability to identify subtle discrepancies in processes or products and have good judgment in determining impact and potential risk;
  • Ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems.
  • Outstanding attention to detail and organizational skills, effective time management and prioritisation skills