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Job Information
Job title

Quality Management

Company Algomod Technologies Corporation
Wage Not specified
Location United States, California, La Jolla
Employment type Contract to Perm
Education Not Specified
Year Experience 4 - 5 Years of Practical Experience
Travel None
Published on 6/8/2005
Description
Quality Management

MUST BE COMMUTABLE DISTANCE TO LA JOLLA

Candidates must have the following: Extensive knowledge of cGMP, GLP and GCP and be able to apply to IT projects.Prior experience in training in a software quality system model ISO 0-3, IEEE, or CMM is highly desirable.

Experience in Information Security Management. Previous hands-on experience in lab instrumentation in pharm lab environment required.3 years Quality Management experience in the Pharmaceutical Industry.

Must have exceptional customer focus and interpersonal skills.See attached job description for additional information.

Required Skills : General Function : : Serves the QM organization as a primary point of contact for quality support requests from the Business &; Informatics to ensure that computerized systems are developed &; managed in accordance with corporate, regulatory &; Informatics standards. Work closely with Informatics project managers, teams and associated Business QA groups to ensure SLC deliverables are consistent &; satisfy the above requirements and meet business needs. Tasks include writing, revising, and verifying QM deliverables Quality Planning &; Compliance Reporting, reviewing and approval of SLC deliverables Project planning, requirements and verification. Tasks also include contributing to implementation and post implementation planning and monitoring to support effective performance and change management practices. Excellent communication skills are required, capable of performing effectively within a project team, or with minimal supervision.


Job Descriptions


Within the scope of informatics quality infrastructure, provide guidance and direction in departmental regulatory compliance activities including Part 11, computer validation/verification activities to project team and ensure preparation and collection of sufficient documentation that meets company policy and standards. Assist in writing computer validation documents.


The individual will assist in implementing quality goals and framework as defined by the IT global QM organization through team collaboration.


Will initiate appropriate processes, construct supporting metrics, and establish local practice and/or SOPs to support local activities as needed.


Requirements


The candidate must have a Bachelors degree in science or IT related technical discipline with at least three years experience in Quality Management and/or Software Quality Engineering, plus three years of hands-on experience computer system validation/verification activities.


The person must be very familiar with full life cycle software development including software release, maintenance and retirement. The person needs to be experienced in adapting classical software lifecycle approaches to computer validation activities.


The person must have pervious experience in writing SOPs, full sets of validation documents, and analysis and summary reports.


The person must be extremely knowledgeable in regulations including cGMP, GLP and GCP and be able to apply to IT project. Experience in information security management. Prior experience in training in a software quality system model ISO 9000-3, IEEE, or CMM is highly desirable.


Previous hands-on experience in lab instrumentation in pharmaceutical and biotech R&D labis required.


Strong Oral and written communications skills a must. Strong interpersonal skills and custom focus are essential.


Self-starter and quick learner. Be able to handle multiple projects in a fast paced environment.




Experience/Skills
QA 2.0 year(s)

QM 2.0 year(s)

QUALITY MANAGEMENT 2.0 year(s)

GMP

CFR

ISO

9000

IEEE

CMM

Other desired skills:
QA 2.0 year(s)

QM 2.0 year(s)

QUALITY MANAGEMENT 2.0 year(s)

GMP

CFR

ISO

9000

IEEE

CMM
This job has expired.