Validation Manager - Manufacturing jobs in Malta - September 2020

Validation Manager

at

Konnekt
JOB TYPE: Full Time JOB LEVEL: Experienced
CATEGORY:
Manufacturing

In the position of a Validation Manager, you will be reporting to the Head of QA and your duties will include:

  • Managing, developing and implementing validation processes to ensure products meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices
  • Leading the assessments and approvals of Validation Strategies, Control Strategies and Holding Time Studies for all products undergoing transfer and commercial manufacturing stages
  • Leading the cleaning validation/verification program and activities including sampling
  • Leading process capability and statistical analysis of OSD manufacturing process
  • Overseeing and reviewing validation area processes and procedures, making recommendations for changes and/or improvements
  • Designing and conducting process validation activities for oral solid drug dosages (OSD) products
  • Preparing documented protocols and reporting for validation exercises in compliance with corporate guidelines, procedures, FDA Regulations and industry-current practices

 

Education and Experience

  • A Bachelor’s degree in Life Science or a related discipline
  • Proven cleaning and process validation experience within the pharmaceutical industry;
  • Ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems.

 

Skills

  • Outstanding attention to detail and organizational skills,
  • Effective time management and prioritization skills
  • Fluency in Maltese and English

This position is with an international pharmaceutical company in Malta. 

 

Job reference code: AC626

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