Basic Qualifications:
– Bachelor’s Degree ( IT, Mathematics, Chemistry, Pharmacy, Biology, or related science or technical field.)
– At least 6 years experience in the pharmaceutical industry with 3 years experience in either Quality Assurance, Quality Management, IT Compliance or equivalent
– Demonstrated proficiency and thorough knowledge of computer system validation (CSV) requirements defined by applicable company requirements, health authorities and/or industry groups.
– Thorough knowledge of quality management and CSV (GMP, 21CFR Part 11, GAMP) aspects of computer system applications.
– Good knowledge of regulatory requirements (FDA, EMEA, ICH)
– Experience in international and multidisciplinary environments and ability to work globally is essential.
– Operational knowledge and experience with cocmuterized system applications in a GXP environment.
– Demonstrated attention to detail and organizational skills.
– Strong interpersonal and leadership skills.
– Experience in CSV auditing and inspections against regulatory and benchmark quality standards
– Sime travel required, up to 20%
– Results driven with a strong customer and quality focus.
– Strong ability to motivate people and to negotiate win-win solutions in a matrix-oriented organization.
– Ability to make decisions, evaluate risks and define and execute action plans.
– Ability to propose innovative solutions to solve problems.
– Bachelor’s Degree ( IT, Mathematics, Chemistry, Pharmacy, Biology, or related science or technical field.)
– At least 6 years experience in the pharmaceutical industry with 3 years experience in either Quality Assurance, Quality Management, IT Compliance or equivalent
– Demonstrated proficiency and thorough knowledge of computer system validation (CSV) requirements defined by applicable company requirements, health authorities and/or industry groups.
– Thorough knowledge of quality management and CSV (GMP, 21CFR Part 11, GAMP) aspects of computer system applications.
– Good knowledge of regulatory requirements (FDA, EMEA, ICH)
– Experience in international and multidisciplinary environments and ability to work globally is essential.
– Operational knowledge and experience with cocmuterized system applications in a GXP environment.
– Demonstrated attention to detail and organizational skills.
– Strong interpersonal and leadership skills.
– Experience in CSV auditing and inspections against regulatory and benchmark quality standards
– Sime travel required, up to 20%
– Results driven with a strong customer and quality focus.
– Strong ability to motivate people and to negotiate win-win solutions in a matrix-oriented organization.
– Ability to make decisions, evaluate risks and define and execute action plans.
– Ability to propose innovative solutions to solve problems.
Details:
Job Purpose:
The Quality Manager, e-Compliance maintains responsibilities for ensuring GxP computerized systems operate within the framework of regulations (GxP, 21CFR11, etc.), applicable QMS, and requirements defined in local procedures. This role will approve the CSV for critical business IT applications. In addition, he/she leads internal e-Compliance related initiatives such as process improvements and periodic reviews.
The Quality Manager, e-Compliance maintains responsibilities for ensuring GxP computerized systems operate within the framework of regulations (GxP, 21CFR11, etc.), applicable QMS, and requirements defined in local procedures. This role will approve the CSV for critical business IT applications. In addition, he/she leads internal e-Compliance related initiatives such as process improvements and periodic reviews.
Key Responsibilities:
– Act as a SPOC (single point of contact) for e-Compliance on assigned computerized systems. Approve key validation deliverables and change management deliverables for computerized systems.
– Expedite implementation of computer systems by overcoming obstacles using a scientific, risk-based approach.
– Maintain customer service relations and develop and sustain professional relationships that reflect commitment to GSK shared values. Foster communication and coordination across the e-Compliance team.
– Lead specialized Quality projects as assigned.
– Work independently by determining and pursuing courses of action to obtain desired functional and business objectives.
– Assist with site compliance reviews.
– Participate in continuous improvement mechanisms. Work with other stakeholders to design. Quality computer systems to interface connectivity with other key business IT solutions.
– Support for internal and external audits and inspections; provide support for follow up/remediation actions as needed. Interact with Health Authorities.
– Lead local CSV committees; defining approach and processes with global Quality Systems. Assist with site CSV inventories and Validation Plans. Perform periodic CSV training sessions.
– Act as a SPOC (single point of contact) for e-Compliance on assigned computerized systems. Approve key validation deliverables and change management deliverables for computerized systems.
– Expedite implementation of computer systems by overcoming obstacles using a scientific, risk-based approach.
– Maintain customer service relations and develop and sustain professional relationships that reflect commitment to GSK shared values. Foster communication and coordination across the e-Compliance team.
– Lead specialized Quality projects as assigned.
– Work independently by determining and pursuing courses of action to obtain desired functional and business objectives.
– Assist with site compliance reviews.
– Participate in continuous improvement mechanisms. Work with other stakeholders to design. Quality computer systems to interface connectivity with other key business IT solutions.
– Support for internal and external audits and inspections; provide support for follow up/remediation actions as needed. Interact with Health Authorities.
– Lead local CSV committees; defining approach and processes with global Quality Systems. Assist with site CSV inventories and Validation Plans. Perform periodic CSV training sessions.
Location: US location is flexible and all GMS CH sites considered.
Role can also be based in Puerto Rico or Pakistan.
Role can also be based in Puerto Rico or Pakistan.
Apply Online:
https://careers.peopleclick.com/careerscp/client_gsk/external1931/jobDetails.do?functionName=getJobDetail&jobPostId=281736&localeCode=en-us
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