1. Position: QA CSV (Validation) Test Script Writer
Duration: 6 Months
Location: Fort Washington, PA
Travel: <10%
Ideal candidate will have QA, Validation of Tester resume with EtQ or NC Software or Trackwise experience
Experience in writing test scripts
Experience writing IQ/OQ/PQ test scripts
2. Position: CSV (Validation) Lead
Location: Fort Washington, PA
Travel: <10%
Description :
The Lead, Computer System Validation is responsible for ensuring that GxP regulated computerized and Automation systems are in full compliance with regulatory requirements, company policies and procedures. Provide compliance leadership, direction and oversight to project teams in Computer System Validation. This individual is responsible for the quality oversight of GxP regulated computerized (e.g. manufacturing plant systems, laboratory systems and enterprise applications). This individual will support leadership and compliance support activities include, but are not limited to SOP revisions, documentation review and approval (including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports). The candidate will manage the release of regulated systems for GxP production use. This individual will support the 24/7 operations of the manufacturing plant, resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 820, 11 and Annex 13). In addition, this individual will lead and participate in project teams and may participate in regulatory inspections (e.g. FDA.)
Assignment duration of the Lead Computer System Validation, CD to last through December 2014.
Education:
A minimum of a Bachelors degree and 6 years of related industry experience OR an advanced degree with 5 or more years of related industry experience is required. A focused degree in a technical, scientific or related field is preferred
Experience/ Technical Competencies:
A minimum of 6 years of business experience is required.
A minimum of 3 years of experience in CSV system development life cycle is required.
Job Knowledge/Skillsets:
Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 is required. Strong knowledge of laboratory systems is preferred.
Six (6) positions will be based in Fort Washington, PA and one (1) will be based in Las Piedras and may require up to 10% travel.
Travel:
There is up to 10% travel anticipated for this role.
3. Position:Computer Systems Validation
Duration: 12-15 Months
Location: Fort Washington, PA
10+ years’ experience with Computer Systems Validation in a Pharmaceutical IT environment with systems such as:
Electronic Document Management Systems
Product Quality Complaint Systems
Change Control Systems
ERP (specifically SAP)
CAPA and Investigation Systems
hands on experience with developing plans, requirements, specifications, test scripts, and summary reports
Experience auditing IT Systems for compliance with CSV policies and procedures
Ability to work independently
Bala
Accounts Manager
SSAI Technologies LLC | Board: 908 450 9465| Fax: 908 842 0244 | www.ssaitech.com | Email: bala@ssaitech.com | bala.ssaitech@gmail.com
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