Local Quality Coordinator

hace 5 días

Lima, Perú AmerisourceBergen A tiempo completo

What you will be doing

PRIMARY DUTIES AND RESPONSIBILITIES:
Convert Directives into local Working Instructions, SOPs, etc, as applicable Assist in purchasing, qualification and set up of technical equipment according to Group, Regional and Local requirements Assist in local interpretation of regulatory and World Courier internal requirements Assessment of quality related activities/ non‐conformances on local level Provide response to client questionnaires in close cooperation with branch/ country manager and Regional Quality Coordinator Schedule client audits and coordinate the audit agenda in close cooperation with branch/ country manager and Regional Quality Coordinator Prepare CDAs on local level Assist in on site preparation for client audits Accompany audits as applicable Coordinate the preparation of audit response in close cooperation with branch/ country manager and Regional Quality Coordinator Follow up on pending audit observations Coordinate local CAPA and Change Management Sign off local CAPA and Change Management Follow up on pending activities Archiving of finalized local CAPA and Change Management processes Authorizing local SOPs Archiving of master copies of local SOPs (electronic master and in case of hard‐copies signed original) Administer locale / national share point (SP) service (where applicable) Archiving of outdated local SOP (if applicable, e.g. when using hard‐copies) Establish appropriate training material and conduct training for general quality topics, e.g. QA SOP, current laws, regulations, directives, etc. Conduct and/ or oversee internal audits in close cooperation with Regional Quality Coordinator Oversee self inspection, check reports Assist in enquiries resulting from new requirements from authorities and/ or clients Coordinate the ISO 9001 and 14001 audit program in the Country 2 Participate in and coordinate local Management Review Meetings (MRM) Coordinate subcontractor qualification in close cooperation with branch/ country manager and Regional Quality Coordinator Assist in the generation and review of Technical/ Quality Agreements with clients and subcontractors Participate in periodic subcontractor assessments for compliance with operational requirements, GxP and ISO compliance. Organize periodic self assessments of the different stations to ensure continued compliance with SOP’s and Policies. Work closely with employee development manager to perform quality audits/reviews of day‐to‐day tasks to ensure compliance with standard workflow procedures and company directives.

What your background should look like

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
Broad operational background in World Courier processes

Basic understanding of Quality Management processes (e.g. ISO 9001)

Adequate GxP expertise

REPORTS DIRECTLY TO:
National Operations Manager

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
Fluency in local language and adequate English skills

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

What AmerisourceBergen offers

We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.

Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.

Schedule

Full time

Affiliated Companies

Affiliated Companies: World Courier del Peru S.A.

Equal Employment Opportunity

AmerisourceBergen is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

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