Inspector, QC (Temp)

Descripción de la oferta

Job Description

Requisition ID: 1805706173W

MISSION

Main responsibility of this position is to sustain Quality management system in Spain Customer Services, Distribution Centers (DC) and supervision of Suppliers (3PLs) of warehousing & transportation in accordance to applicable local regulations and J&J requirements.

Has the responsibility for ensuring that quality system and processes are implemented and maintained accorder to Business Quality Manual.

REPORT TO

Spain CLS Q&C Lead

Functional Group: CLS Q&C

Direct Reports: N/A

MAIN FUNCTIONS

Essential duties and responsibilities :

·  Built and sustain positive relantionships with the 3PL

·  Represent the company with health authorities in Product Quality activities when considered necessary by Quality Executive

·  Implement the Quality System via transposition of the requirements of the requirements of CLS Q&C. Establish required processes and procedures to comply with applicable local regulations and J&J requirements.

·  To control actions related to Quality & Compliance at local 3PL, including warehousing, transportation & reverse logistics including returned goods inspection and items for destruction verification, mainly for Jannsen Cilag SA, guarantying product quality, identity and traceability throughout the supply chain, ensuring that GMP/GDP are fulfilled.

·  To control actions related to San Sebastian de los Reyes DC Quality Area (QACage) at local distribution center, specifically returned goods inspection and items for destruction verification.

·  To collaborate in the customer notifications related to Recalls and/or Field Safety Corrective Actions when required

·  Collaborate in the preparation of data for monitoring quality system performance versus local and J&J requirements via use of pertinent business and compliance metrics and goals, cooperating in the continuous improvement.

·  Coordinate the effective implementation with CLS Operations / CLS CS

·  Ensure Distribution Center/3PL Audit Readiness, in accordance to health authority requirements.

·  Accountable for the oversight and execution of Quality Management Systems and compliance at DCs and 3 PLs in Spain that receives, pick, pack, store, inspect, and deliver finished goods to end users.

·  Serves as a single point of contact to the corresponding CLS operational lead on Distribution Quality related matters and liaises with multiple Quality organizations to drive timely resolution of Quality related issues.

·  Revision of Janssen Cilag income lots & Consumer lots to be returned to stock from returns, prior to RP approval if applicable

·  Quality Auditor, if applicable

·  Notify the QE with any substantive concerns regarding product quality, safety and/or compliance, as per Escalation procedures.
·  Report al suspected adverse reactions, serious or non-serious, may be aware of within a maximun of 24 hours after being aware of it and communicate I to the Pharmacovigilance Department.

Special requirements:

·  As part of a cross sector organization, collaborate in any required cross sector CLS Q&C project or support to required areas

Other features of the job:

This role must maintain a close working relationship with local Commercial organization, with inclusion of specific Goals & Objectives related to current business priorities.

Perfil buscado

Qualifications

JOB PROFILE

Experience
·  Very valuable 1 or 2 years working experience in a quality role within an International Pharmaceutical/ Medical Devices Company.
·  Valuable 1 or 2 years working experience in a quality role or similar

Academic Training and Knowledge
·  Knowledge of ISO 9001 Standard or equivalent quality standards and J&J Quality & Compliance standards
·  Knowledge of Pharmaceutical /Medical Devises & Cosmetics regulations.
·  Audit Management experience (Health Authorities, Notified Bodies, J&J internal audits) and supplier audit.
·  Bachelors or Master degree in Pharma or Bioscience with relevant experience and background in Quality area.
·  User level knowledge of office IT and Excel
·  Qualificaton for internal audis

Essential requirements

·  Excellent written and oral local language and English communication skills
·  Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority
·  Strong collaboration skills and ability to build partnerships internally and externally
·  Ability to effectively present information to Management and public groups
·  Change management experience and influencing and interpersonal skills
·  Analytical skills with bifocal approach, being able of strategic approach keeping tactical and detailed focus.
·  Initiative and teamwork abilities
·  Confidentiality
·  Detail oriented


Primary Location
Spain-Community of Madrid-Madrid-
Organization
Johnson & Johnson, S.A. (8500)
Job Function
Quality Control
Requisition ID
1805706173W