Saturday, 15 June 2024 17:00

Validation Specialist

   Ireland |  Full-time regular

Apply Now

Posting Date :  2024-05-29

Job Identification :  172

Department  :  Validation

Rate this item
(0 votes)

The primary purpose of this role will be to manage the assigned Validation projects and actions on a day-to day basis ensuring that BAHL remains compliant in relation to Validation cGMP.  In addition, the successful candidate will support all BAHL departments in relation to ongoing Validation activities.

 

The successful candidate will report to the Validation Manager.  This fast pace and varied role will encompass validation activities across a range of activities including, Equipment Qualification, Process Qualification, Temperature Mapping, Cleaning Validation and New Product Introduction.


Key Role Specific Requirements:

  • Ensuring that Validation project schedules and associated action timelines are adhered to through timely execution of the Validation Master Plan (VMP).
  • Building effective working relationships with all BAHL departments ensuring that there is minimal impact to production schedules and supporting department processes.
  • Attending Daily Tier 1 team meetings to identify issues impacting on Validation project timelines and to develop remediation plans address these issues.
  • Acting as a Validation SME during HA audits as required.
  • Supporting and executing continuous improvement initiatives from a Validation perspective.
  • Preparing and executing Validation Protocols and completing associated Validation reports for Validation projects.
  • Ensuring investigation, review and reporting of OOS validation results is carried out and documented as per validation protocol.
  • Supporting Deviation, CAPA, FMEA, RCA and Change Control closure from a Validation perspective.
  • Support the implementation of process control and ensure process capability is maintained and identify opportunities for process improvement.
  • Support Process and Equipment Validation including DV, IQ, OQ, PQ protocol development, implementation, and report completion.
  • Support the BAHL Cleaning Validation program as required.
  • Conduct Risk Management / FMEA / Statistical analysis as required.


Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.


Competencies Required for the Role:

  • ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations.  Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.
  • CREATIVITY AND INNOVATION - is the ability to create, develop and implement a new product, process or service with the aim of improving efficiency, effectiveness or competitive advantage. Also, the ability to transcend traditional ideas, rules, patterns, relationships, or the like, and to create meaningful new ideas, forms, methods, or interpretations.
  • EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – to help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts whilst adapting to one’s audience.  Exhibit willingness to listen and show respect for oneself and others in interactions with others.   express oneself clearly in verbal and business writing.
  • PROCESS IMPROVEMENT – involves the business practice of identifying, analyzing, and improving existing processes to optimize performance.
  • THOROUGHNESS/DETAIL ORIENTED – is ensuring that one’s own and others’ work and information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.


Other Requirements:

Experience:

  • Experience working in pharmaceutical industry in a Validation role (1-3 years).
  • Experience in implementing a Cleaning Validation programme.
  • Experience in New Product Introduction (NPI) and the role the Validation Department has in supporting these projects.
  • Experience in equipment and process validation, with knowledge of quality assurance, quality control and compliance aspects that are required to support these. 
  • Experience in Continuous Process Verification (CPV).


Educational:

  • Bachelor’s degree in chemistry, biology, microbiology, or a related discipline.  
  • Experience in a Manufacturing environment.
  • Experience of operating within a GMP environment


Desirable:

  • 1-3 years validation experience
  • Experience working within a multi-disciplinary team.
  • Project experience

 

Read 1 times Last modified on Saturday, 15 June 2024 17:00

Media

vince
More in this category: « Validation Engineer/Manager

glassdoor reviews