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EPM is currently partnering with a client from the Life Sciences Industry and growing in the swiss market.
Jobtitle: Head of Commissioning / Verification / Qualification
Description:
The position holder has several years of experience in CVQ (Commissioning, Verification and Qualification) activities, especially taking care of pharmaceutical project engineering and in qualification and validation topics and a good understanding of technical installations and pharmaceutical processes. You are familiar with innovative quality management tools and systems and you have expert knowledge in GMP. The role is in close contact with the local engineering, automation, manufacturing and quality department's leadership teams as well as with the maintenance & utilities teams to ensure a strategic alignment for all the CVQ activities.
A day in the Life:
*Leading and managing the CVQ team at the swiss site, taking ownership for all functions within
CVQ
*Motivates and guides the CVQ team and addresses personnel issues as they arise immediately
*Ensures adequate resources for an efficient and reliable CVQ procedure and operation in alignment
with the company strategy
*Ensure the sustainable technical operation for all new facilities, a cost-effective CVQ approach for
different projects across the entire site
*Supports the management as well as team leaders from other departments in relation to CVQ
subject matter
*Represents CVQ during GMP audits and inspections
*Establishes monthly department reports to Head P&S
*Encourages a culture of continuous improvement and development of technologies and
procedures within CVQ
*Responsible for all CVQ activities at site for all the different projects
*Responsible for the development and continuous improvement in regards of compliance topics,
establish work standards with current GMP and regulatory requirements in collaboration with the
quality department
*Ensures the compliance with health, safety and environmental requirements within CVQ
*Exchange of information between the various departments and sites with qualification strategies
and regarding all CVQ tasks and duties
*Continuous improvement of GMP compliant re-qualification and calibration systems based on
current industrial principles and regulatory requirements
*Develop commissioning strategies to ensure GxP compliance of manufacturing and infrastructure
systems in an efficient way
*Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS
functions and endorsed by the site management.
*Adheres to general cGMP rules, Quality policies, procedures and instruction as rolled out by the
Quality function and endorsed by the site management
Educational Background:
*Bachelor's degree or equivalent experience; educational concentration in pharmaceutical
engineering, chemical engineering or equivalent Experience
*Profound experience working in the pharmaceutical sector in a GMP environment
*Relevant qualification in a Quality field or relevant working experience within the are
*Experience of positively dealing with distractions or barriers to progress
*Ability to plan and prioritize with drive and determination - results orientated and able to meet
deadlines
*Willingness to learn new skills and embrace procedures
*Effectively liaise with Engineering and QA at all staff levels
Knowledge, Skills, Abilities
*Excellent verbal and written communication skills in English and German
*Very good understanding of GMP guidelines
*Proven track record of dealing with Commissioning, Verification and Qualification
*Good understanding of technical installations and pharmaceutical processes
*Familiar with innovative quality management tools and systems
What they offer:
*Employment with an innovative, future-oriented organisation
*Outstanding career and development prospects
*Company pension scheme and other fringe benefits
*Exciting company culture which stands for integrity, intensity, involvement and innovation
Head of Commissioning, Verification and Qualification
- Location Switzerland
- Job type Permanent
- Salary Negotiable
- Discipline Bioengineering & Medical Engineering
- Reference PR/353152_1650629221
Jobtitle: Head of Commissioning / Verification / Qualification
Description:
The position holder has several years of experience in CVQ (Commissioning, Verification and Qualification) activities, especially taking care of pharmaceutical project engineering and in qualification and validation topics and a good understanding of technical installations and pharmaceutical processes. You are familiar with innovative quality management tools and systems and you have expert knowledge in GMP. The role is in close contact with the local engineering, automation, manufacturing and quality department's leadership teams as well as with the maintenance & utilities teams to ensure a strategic alignment for all the CVQ activities.
A day in the Life:
*Leading and managing the CVQ team at the swiss site, taking ownership for all functions within
CVQ
*Motivates and guides the CVQ team and addresses personnel issues as they arise immediately
*Ensures adequate resources for an efficient and reliable CVQ procedure and operation in alignment
with the company strategy
*Ensure the sustainable technical operation for all new facilities, a cost-effective CVQ approach for
different projects across the entire site
*Supports the management as well as team leaders from other departments in relation to CVQ
subject matter
*Represents CVQ during GMP audits and inspections
*Establishes monthly department reports to Head P&S
*Encourages a culture of continuous improvement and development of technologies and
procedures within CVQ
*Responsible for all CVQ activities at site for all the different projects
*Responsible for the development and continuous improvement in regards of compliance topics,
establish work standards with current GMP and regulatory requirements in collaboration with the
quality department
*Ensures the compliance with health, safety and environmental requirements within CVQ
*Exchange of information between the various departments and sites with qualification strategies
and regarding all CVQ tasks and duties
*Continuous improvement of GMP compliant re-qualification and calibration systems based on
current industrial principles and regulatory requirements
*Develop commissioning strategies to ensure GxP compliance of manufacturing and infrastructure
systems in an efficient way
*Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS
functions and endorsed by the site management.
*Adheres to general cGMP rules, Quality policies, procedures and instruction as rolled out by the
Quality function and endorsed by the site management
Educational Background:
*Bachelor's degree or equivalent experience; educational concentration in pharmaceutical
engineering, chemical engineering or equivalent Experience
*Profound experience working in the pharmaceutical sector in a GMP environment
*Relevant qualification in a Quality field or relevant working experience within the are
*Experience of positively dealing with distractions or barriers to progress
*Ability to plan and prioritize with drive and determination - results orientated and able to meet
deadlines
*Willingness to learn new skills and embrace procedures
*Effectively liaise with Engineering and QA at all staff levels
Knowledge, Skills, Abilities
*Excellent verbal and written communication skills in English and German
*Very good understanding of GMP guidelines
*Proven track record of dealing with Commissioning, Verification and Qualification
*Good understanding of technical installations and pharmaceutical processes
*Familiar with innovative quality management tools and systems
What they offer:
*Employment with an innovative, future-oriented organisation
*Outstanding career and development prospects
*Company pension scheme and other fringe benefits
*Exciting company culture which stands for integrity, intensity, involvement and innovation