Multiple Positions: Several East Coast Projects Starting .....

expecthealth specmark at aol.com
Fri Jul 23 19:21:11 CEST 2004


1) 
Location: Stamford, CT. 
Start Date: ASAP 
Length of Assignment: 6 months or more 
Bill rate: $52/hr all inclusive 
We have exciting opportunities for a CAPA Auditing Consultant to work 
with a talented team of Consultants.

This project will support the maintenance and completion of an 
internal and external auditing program including Corrective and 
Preventative Action (CAPA) management.

The deliverables for each audit include:
o Create audit plans for each internal and external audit.
o Create and send audit notifications and agendas.
o Complete audit checklists during the execution of each audit. The 
checklist is tailored for each audit as required.
o Create an audit report outlining the findings. For external audit, 
there is a version for internal use and one that is released to the 
vendor.
o With the audited group, coordinate the corrective and preventative 
actions (CAPAs) that are required to close findings.
o Manage the verification and closure of CAPA items and provide 
regular feedback on the status of CAPAs to appropriate management.
o Issue the audit closure statement when all CAPAs are complete.
o Maintain the audit files insuring that all related documentation is 
available for future use.
o Collect, analyze, and distribute audit and CAPA metrics as required.
* Perform and document ad hoc system assessments as required as a 
result of regulatory inspections, GMP Investigations, or as directed 
by management.

REQUIREMENTS:

EDUCATION
Minimum Education Level: Bachelors Degree


EXPERIENCE
Experience: 5-10 Years
Mandatory Industry Experience: Pharmaceutical

SKILLS
Primary Skills:
- Knowledge of cGxPs.
- Knowledge of Part 11.
- Experience as a lead auditor of a team.
- 5-7 years Pharmaceutical computerized system auditing experience.
- Experience developing Corrective and Preventative Actions that 
match the level of non-compliance.
- Good communication skills (especially important in representing the 
client when dealing with external vendors and in representing the 
client with internal auditees).
- Good writing and documentation skills.
- Adaptability and flexibility.
- Ability to work independently and as a team member.

2) 
Team Lead of Lab Systems 
Location: Cranford, NJ 
Start date: ASAP 
Length of Assignment: 6 months or more 
Bill rate: $42-47 / hr all inclusive, depending on experience. 
Job Description:
- 7-10 years of experience in the pharmaceutical industry. 
- Experience with validation and implementation for the following lab 
systems; FT-IR, TOC-Analysis and UV/Vis.
- Working knowledge of Part 11 remediation and system development 
life cycle.
- Ideal candidate must have excellent communication skills both 
verbal and written.
- Candidate must be a self-starter requiring minimal supervision.
- This position will interface with multiple sites, experience 
interpersonal skills is a must!
- 40% Travel (some international). 
3) 
Team Lead - Manufacturing Systems 
Location: Northern NJ 
Start date: ASAP 
Length of Assignment: 6 months or more 
Bill rate: $43-47 /hr all inclusive 
- 7-10 years of experience in the pharmaceutical industry. 
- Experience with validation and implementation for the following 
manufacturing systems; Intouch (Wonderware) and iFix (GE Fanuc).
- Working knowledge of Part 11 remediation and system development 
life cycle.
- Ideal candidate must have excellent communication skills both 
verbal and written.
- Candidate must be a self-starter requiring minimal supervision.
- This position will interface with multiple sites, excellent 
interpersonal skills is a must.
- 40% travel is required (some international).

4) 
Validation Consultant of Lab Instruments and Computer Systems 
Immediate need...we have a project that needs a stand alone member in 
Toronto, Canada...we have the job, we just need the candidate.
Start date: Between 7/26 and 8/2 
Assignment will be approximately 2 months or so. 
Bill rate is $37 -40/hr, plus travel and expenses! 
Responsibilities: 
System Assessments 
* Review of existing assessment reports. 
* Review of validation documents. 
* Performance of compliance assessments where required. 
Remediation Planning 
* Analysis of existing remediation plans. 
* Performance of compliance risk assessments. 
* Development of Remediation Plans where required. 
Implementation of Remediation Plans 
* Support replacement of instrument systems. 
* Support upgrades of instrument systems. 
* Validation of instrument systems. 
* Preparation and/or revision of compliance documentation including: 
- Validation Plan(s) 
- Requirement Documents 
- Design Specification(s) (High level flow) 
- Traceability Matrix 
- IQ/OQ/System Level Test (SLT) Plan 
- Change Control Documentation 
- Operational Support 
- SOPs/Training 
- Security Plan(s) 
- Business Continuity /Disaster Recovery Plan(s) 
- Vendor Audit(s) 
- Records Retention Plan(s)    
Competencies Required (knowledge, experience, abilities): Proven 
experience with all of above. Validation experience with lab systems 
in the pharmaceutical environment. Excellent consulting and 
communication skills. Excellent writing skills.      

5) 
Location: Stamford, CT 
Start date: ASAP 
Length of Assignment: 3 months 
Bill rate: $32 34 /hr all inclusive 
We have an exciting opportunity for a Computer Systems Compliance 
Auditor.

Job Description:
- Review open audits to identify follow-up actions required.
- Complete started audits.
- Contact vendors/auditees to close out actions.
- Write closure memos (after all actions are closed) to close out 
these audits.
- Conduct new audits as required with full documentation.

Primary Skills:
- Knowledge of cGxPs.
- Knowledge of Part 11.
- Experience as a lead auditor of a team.
- 5-7 years Pharmaceutical computerized system auditing experience.
- Experience developing Corrective and Preventative Actions that 
match the level of non-compliance.
- Good communication skills.
- Good writing and documentation skills.
- Adaptability and flexibility.
- Ability to work independently and as a team member.

6) 
InForm Validation Consultant 
Location: Kenilworth, NJ 
Start date: ASAP 
Length of Assignment: 1 year 
Bill rate: $44-46  /hr all inclusive 
Job Description:

- 4 or more years of experience working in the pharmaceutical 
industry.
- Experience should include generation of validation documents for 
clinical systems.
- Experienced in developing validation strategies for clinical 
systems.
- Extensive knowledge of GxPs, computer validation, and Part 11 
requirements.
- Experience project management skills.
- Must have previous Inform experience.

Please forward your resume / cv to:

Bill Norris
DIAMOND CONSULTING INC.
specmark at aol.com
630-586-0000 x19








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