*Hi All, Hot Requirement MAX RATE $35/HR On C2C*

Do you have any QA GCP manager, this is a clinical position?



*QA Mgr*

*Description***

*Purpose*

Provide support to mgmt in the promotion and assessment of compliance with
regulations, guidelines, and operating procedures. Manage QA oversight of
projects, assignments, and training. Conduct independent audits to assess
compliance with regulations, guidelines, and operating procedures. Prepare
and distribute reports of findings to operations staff, management, and
customers. Provide consultation in interpretation of regulations,
guidelines, policies, and procedures.

*RESPONSIBILITIES*

   - Plan, schedule, conduct, report and close audit activities in any of
   the countries involved with XXX contracts. Audits are conducted to assess
   compliance with applicable regulations/guidelines, customer requirements,
   SOPs and project specific guidelines/instructions.
   - Evaluate audit findings and prepare and distribute reports to
   operations staff, management, and customers.
   - Provide interpretation and consultation to project teams on
   regulations, guidelines, compliance status, and policies and procedures.
   - Provide consultation to customers, functional leads and monitors in
   interpretation of audit observations and formulation of corrective action
   plans.
   - Prepare, review and approve corrective action plans
   - Present educational programs and provide guidance to operational staff
   on compliance procedures.
   - Conduct quality assurance consultancy activities and projects for
   clients within budget and established timelines.
   - Evaluate policies and procedures for compliance with applicable
   regulations/guidelines and provide recommendations to management for
   continuous process improvements.
   - Host customer audits
   - Host mock regulatory inspections and regulatory facility inspections
   - Provide training for new Quality Assurance staff.
   - Serve as author of Quality Assurance SOPs as assigned.
   - Advise Quality Assurance management on system audit needs.
   - Act as regional or Global QA Coordinator for assigned customers
   projects
   - Oversee documentation, reporting, and closure of compliance issues,
   lead Projects.
   - Train new auditors and staff as required.

*Qualifications***

Knowledge of word-processing, spreadsheet, and database applications.

Extensive knowledge of pharmaceutical research and development processes
and regulatory environments.

Considerable knowledge of quality assurance processes and procedures.

Strong interpersonal skills.

Excellent problem solving, risk analysis and negotiation skills.

Exceptional training capabilities.

Effective organization, communication, team orientation, and leadership
skills.

Ability to work independently with initiative with the ability to manage
multiple projects.

Ability to establish and maintain effective working relationships with
coworkers, managers and clients

*MINIMUM REQUIRED EDUCATION AND EXPERIENCE*

Bachelor’s/primary degree

7 years Quality Assurance experience in pharmaceutical, technical, or
related area; or equivalent combination of education, training and
experience; or equivalent combination of education, training and experience



*Thanks and Regards,
Ryan Marshall | Panzer Solutions LLC
45 Stuart Ave, K  Norwalk CT 06850 USA
Direct:203 652 1444 ext 127| Fax: 203-286-1457 ,
E-mail:ryan.marsh...@panzersolutions.com

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