Cleaning Validation Specialist

Job description

Details:
Job Purpose
• Implement and maintain the site cleaning validation policy
• Implement the site cleaning validation program for new equipment/processes across each value stream
• Support the introduction of new or improved process cleaning initiatives.

GSK Behaviours

Flexible Thinking
Demonstrate the ability to:
• Being open to different views and ideas
• Assess a situation, seek multiple perspectives, gather more information if necessary, and identify key issues that need to be addressed.
• Find solutions to problems using creativity, reasoning, and past experiences along with all available information and resources

Developing People
• Have an awareness of the need and value for developing oneself

Continuous Improvement
• Always look for ways to simplify and improve processes

Enable & Drive Change
• Being responsible and accountable for tasks and projects, implement plans and drive a results – oriented culture
• Effectively plan work and manage projects to specific deadlines.

Customer Driven
• Understand the customers point of view, needs and requirements

Building Relationships
• Being non-evaluative and non-judgmental about understanding the views of others.
• Ability to relate to co-workers, inspire others to participate, and mitigate conflict

Interpersonal & Communication Skills
Ability to communicate with a wide variety of people at all levels both within and externally (e.g. Vendors) through appropriate skills:
• Verbal/Written
• Negotiation
• Report Writing
• Presentation
• Empathy/Affiliation
• Listening

Multi-cultural responsibility
• Be aware of cultural sensitivities and be able to build rapport with a diverse workforce when required.

Scope of Responsibility (primary deliverables expected of the role)
• Generate and execute documentation for cGMP validation cleaning protocols and reports.
• Work closely with Quality and Manufacturing Operations to ensure successful execution of cleaning validations
• Ensure that all cleaning validation data, results & information are recorded accurately, completely and in accordance with the written procedures.
• Support compliance inspections and enquiries from regulatory agencies
• Support each Value Stream in relation to cleaning Deviations and RCAs
• Ensure Halal requirements are met in accordance with General Guidelines of Halal Assurance System LPPOM MUI for applicable Medical Device products/ markets.
Impact of role on business objectives
Implementation of tactical plans in relation to Cleaning Validation

Environmental Health & Safety (EHS) Responsibilities
• Perform duties in a compliant manner and behave in accordance with Site SOP's GSK EHS Standards and guidelines and relevant legal requirements.
• Read and understand Standard Operations procedures applicable to Role.
• Report all accidents, incidents and any EHS issues using the appropriate process/ System to your manager, or if required the Occupational Health Advisor.
• Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards,
• Be aware of the impact of your job activities on EHS issues
 
Quality Responsibilities
• Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements
• Participate fully in our site's quality initiatives and ensure that all relevant quality standards are adhered to.
• Maintain GMP standards where appropriate to your role
• Read and understand relevant Standard Operating Procedures and Global Quality applicable to role
• Attend training and complete assessments as required
• Ensure Quality and GMP are at the forefront of changes proposed.

Problem Solving
• Be able to understand the principles in trouble shooting equipment / automation systems issues.
• Use of root cause analysis.
• Use of OE Tools.

Specialised Knowledge
Basic Experience
1-2 years experience with Cleaning / Equipment Validation.

Preferred Experience
2-3 years in a Cleaning Validation / Equipment validation role.

Expected level of application of Knowledge
Working Knowledge of Validation lifecycle

Contact information:
You may apply for this position online by selecting the Apply now button.

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jobDetails

Desired profile

Basic qualifications:
Third level qualification in a science related discipline (preferably post Microbiology or Chemistry).

Preferred qualifications:
Primary degree in a science based discipline.