1 GMP Auditor Job in Conshohocken, PA

SORT BY

SET JOB ALERT

OFF

Details...

GMP Auditor

PharmaLex

Conshohocken, PA | Contractor

$94k-118k (estimate)

2 Months Ago

GMP Auditor

PharmaLex Conshohocken, PA

$94k-118k (estimate)

Contractor | Educational Support Services 2 Months Ago

Save

Sorry! This job is no longer available. Please explore similar jobs listed on the left.

PharmaLex is Hiring a GMP Auditor Near Conshohocken, PA

JOIN OUR TEAM!PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm and diligence.General Description:We are seeking consultants who can provide support as a GMP Auditor in the pharmaceutical and biotechnology industry.Responsibilities:

Conduct and manage quality, compliance, and auditing activities to provide assurances that operational activities are conducted in compliance with applicable regulations, guidelines and the company’s policies and standards.
Support contracted audits to verify compliance.
SME to assist with facilitation of audits in preparations for and participate in regulatory authority inspections.
Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses.
Provide consultation and compliance advice for the organization and support a quality framework that protects patient safety and assures regulatory compliance.
Interpretation of regulations and guidelines, searches of published information and interactions with other QA and regulatory professionals.
Support compliance projects such as management of quality issues, CAPA projects, or other Quality Assurance and cross-functional initiatives.
Delivery of training in performance of audits (basic, intermediate, complex).

Requirements:

A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline.
Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable.
10 years industry experience on a GMP regulated facility
With lead auditor certification is preferred
Experience of industry quality systems/standards.
- US Regulations: 21 CFR 4, 11, 210, 211, 600, 610, 820
- EU Regulations: Eudralex Volume 4, Chapters 1-9, Part II, Annex 1, Annex 2, Annex 11, Annex 15, Annex 16, Annex 19
- Applicable national and international management system standards (e.g., ISO 9001, ISO 14644, ISO 17025, etc.
- National and international industry guidelines, standards and current industry practices (e.g., ISO, WHO, USP, EP, JP, GAMP, etc.)
Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving.
Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios.