GMP Compliance Auditor (m/w/d)

Als kompetenter Personaldienstleister bringt PERSONALHANSA seit 40 Jahren Menschen in Arbeit. Mit Engagement und Expertise gelingt es uns die Interessen der Bewerber und unserer Kunden bestmöglich in Einklang zu bringen. PERSONALHANSA ist Mitglied der BAP/DGB Tarifgemeinschaft. Berufsanfänger und Berufserfahrene erhalten bei uns, neben sehr guten Verdienstmöglichkeiten, attraktive und sichere Orientierungsmöglichkeiten auf dem sich ständig ändernden Arbeitsmarkt.

Wir suchen für unseren Kunden in der Metropolregion Rhein-Neckar einen

GMP Compliance Auditor (m/w/d)

Hauptaufgabengebiet:

Carryout job duties independently, including interpret, explain and apply applicable current regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies

Independently plan and conduct internal system audits and external GxP supplier audits

Maintain approved supplier list, global audit schedule and participate in supplier management processes

Gathers internal and external audit metrics and presents to QA management for trend analysis

Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues

Provide guidance and training on GxP regulations and guidelines to GxP auditors and functional areas personnel

Assist GxP QA Management on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers

Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities

Expected to elevate any issues to management, as necessary, in meeting these responsibilities. Leads goals with cross-functional or broader scope. Resolves project team issues with minimal oversight

Qualifikationen:

Bachelor’s degree preferably in life sciences or engineering

Demonstrated strong leadership competencies, proficient level of technical capabilities, and independence. Proven track record utilizing core & technical competencies

Thorough understanding of international GMP regulatory standards

5+ years experience in function or related fields such as:

· Quality Assurance / Regulatory Affairs

· Pharmaceutical / Device / Healthcare Industry

Quality Assurance auditing experience (preferred)

Laboratory experience (preferred)

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above

Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ) Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA))

Unsere Leistungen:

Vergütung mindestens nach BAP/DGB Tarifvertrag

Einsatzbedingte Zulagen und/oder Branchenzuschläge

Urlaubs- und Weihnachtsgeld

Arbeitszeitkonto auf Wunsch erst ab der 41. Wochenarbeitsstunde

Dauerhaft Einsätze – keine Tageseinsätze

25 % Zuschuss zum Deutschlandticket

Übernahmeoption bei unseren Kunden

Intensive Betreuung / Beratung bei der beruflichen Weiterentwicklung