Senior QA Compliance Auditor Drug Development 6873
Company: True North Consulting LLC
Location: Indianapolis
Posted on: November 19, 2023
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Job Description:
Senior QA Compliance Auditor Drug Development 6873 Apply
Location Indianapolis, IN
Type Contract ID BU82-2729289 Posted Oct 20, 2023 This is a
contract job opportunity. potential for perm Position: Senior QA
Compliance Auditor Drug Development 6873 Location: Indianapolis IN
Schedule: 1st shift Job code: CVDJP00026873 Benefits are available
Candidates will need to go into office. Will definitely need to be
in office for audits and other required days Summary: The main
function of a compliance analyst is to ensure the organizations
operations and procedures meet government and industry compliance
standards. A compliance analyst may research regulations and
policies, communicate requirements, and apply for compliance
certifications on behalf of the organization. Job Responsibilities:
Researching industry compliance regulations and policies.
Evaluating internal operational and procedural compliance.
Analyzing and updating existing compliance policies and related
documentation. Communicating compliance policies and guidelines to
Management and designated departments. Developing and executing new
compliance policies and procedures as required. Applying for
compliance certification and regulatory approval. Developing and
maintaining a compliance recordkeeping system. Training employees
on industry compliance requirements. Maintaining communication with
compliance regulators and following up on applications. Keeping up
with compliance requirements and amendments to regulations.
Requirements: Industry related bachelors degree or related
experience. Compliance management certification preferred.
Knowledge of compliance management software. Advanced analytical
abilities. Good communication and interpersonal skills. 5-7 years
of experience. - Conduct work as identified on the audit activity
table (listing on table is not all inclusive but a
representativesample) - Contributes to global QA policies on
interpretation/ application ofregulations. - Provide subject matter
expertise to projects Support team in CAPA plancreation. - Hosts
external audits/inspections e.g., regulatory inspections, strategic
clients. Assists with the facilitation of auditresponses. -
Supports the QA-to-QA relationship with keyclient(s) - Delivery of
training in performance of audits (basic, intermediate,complex) -
Participate (for multi-regulatory topics in area of expertise)
global Quality initiative(s) aimed at improving compliance and/or
efficiency of the QAorganization. - Supports the reporting of
quality metrics and implementation of necessary correctiveactions
and/or process improvements via appropriate forum (e.g., Monthly
Reports, Site Quality Review, Liaisonmeetings) - Ensure Regulatory
Compliance and Quality Assurance (RC&QA) responsibilities,
asindicated in applicable controlled documents, arefollowed. -
Other duties as assigned bymanagement. - 5 years in regulatory
environment (experience in GXProles) - Experience of industry
qualitysystems/standards - Excellent interpersonal/organizational
skills, e.g., communication, decisionmaking, negotiating,
problemsolving - Able to influence QA strategy systems/standards
and ability to apply appropriate regulatory knowledge to
multiplescenarios. Recommended: - A minimum of a bachelor's degree
in a Pharmacy, Chemistry or Biology relateddiscipline -
Postgraduate degree (MSC or equivalent) in science or management
relateddiscipline, preferable - Experience may be substituted
foreducation.
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Keywords: True North Consulting LLC, Indianapolis , Senior QA Compliance Auditor Drug Development 6873, Accounting, Auditing , Indianapolis, Indiana
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