Description
This position entails performing routine GMP Audits as well as speciality and technical audits in relation to current products and prospective in-license agreements, providing compliance guidance and support throughout the Quality and Compliance organisation, training delivery, and leading multi-departmental teams and initiatives.Responsibilities:
-Independently conducts, and reports external foreign and domestic audit activities of a complex nature, such as API, Due Diligence, Sterile Production, and any other new technology or speciality facility audits.
-Plan and strategies long term audit programs and department activities, such as inter facility training, internal site visits, and participate on various teams and projects.
-Provide guidance in managing and controlling the implementation of changes that may impact product quality and regulatory compliance.
-Provide technical guidance and support to local plant Quality Operations functions by assessing, troubleshooting and recommending solutions to resolve compliance issues.
-Contribution to various company wide harmonization efforts, e.g. supplier management, audit tracking modules, and training modules / programs is expected.
Person profile:
-Minimum Bachelor's degree in a scientific discipline.
-Minimum of 7+ years related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing. Medical device industry experience is a plus.
-ASQ Certification as a Quality Auditor, Manager or Engineer a plus.
-Superior knowledge of S. cGMPs and FDA guidance.
-Superior knowledge of EU GMPs and ICH Guidances and International Standards (Risk Management, ICH 8, 9, 10)
-Knowledge of drug product manufacturing, packaging, laboratory, and warehousing operations.
Skills:
-Strong interpersonal skills.
-Effective organizational development skills.
-Excellent written and verbal communication skills.
-Effective influence management and conflict resolution abilities
-Highly developed investigative and reporting skills.
-Effective organization and time management skills.
-Expected to work and grow in a team oriented environment and continue to build synergies between the corporate compliance group and internal and external quality and manufacturing groups.
Abilities:
-Ability to travel. (40-50%)
-Ability to generate and/or maintain reports, databases and presentations using Microsoft Office.
This is a great opportunity within a growing company and an attractive salary and benefits package is on offer to hear more apply below with an up to date CV and I will call you with more information.