*summary*:
responsible for managing qms documents, (sops, wps, wis, frms, etc) issuance, updates, withdrawals & periodic reviews from initiation until completion assuring that the processes adhere to the novartis qm directives, global sops, health authorities requirements.
*about the role*:
*major accountabilities*:
- coordinate the issuance and the update of qms documents (including standard operating procedures, work instructions, frms, etc.), in order to ensure compliance with novartis standards & health authorities requirements.
- review capas plans in order to identify required changes (inclusions, deletions, modifications) in qms documents.
- perform the role of sop manager and coordinator within electronic document management systems.
- set and provide input on priorities for owned activities.
- demonstrate customer-oriented service mindset in handling and executing deliverables.
- responsible for data compilation and preparation of dashboard on a regular basis to track and report deliverables.
- regularly communicate with customers and partners to collect feedback on support services.
- responsible for writing and updating sop’s applicable to owned activities.
- follow-up on the actions determined by audits, self-inspection, quality manual, etc. for the document management aspects.
- ensure efficient, timely and clear communication to all involved partners (local and global functions) as required for flawless follow-up on activities under scope.
- communicate progress and deviations as appropriate in collaboration with team leader.
- build and maintain high expertise and continuously acquire process knowledge.
*key performance indicators*:
- document management & artwork processes kpis and kqis.
- high customer satisfaction/responsiveness (no customer complaints).
- adherence to project timelines and proactive management of upcoming issues.
- generation / delivery of reports related to the administration qms documents.
- no issues due to non-observance of cgmp, sops and no critical deviations.
*minimum requirements*:
*work experience*:
- scholarship: professional related to chemical-biological areas: if, iq, iqi, ibt, ib, qfi, qfb, qbp, lf or project management with pharma experience.
- experience/professional: approximately one year of experience in pharmaceutical industry are desirable. Solid experience in data analysis and reporting.
*skills*:
- knowledge: quality systems; continuous improvement; good manufacturing practices; local/international health regulations;
- skills: strives for simplicity and clarity; digital technology savvy; continuous learning; solution oriented behavior; self organization; stakeholder engagement; organizational savvy; effective communication; breakthrough analysis; agile mindset; agile teams.
*languages*:
- english.
Division
operations
business unit
innovative medicines
location
mexico
site
insurgentes
company / legal entity
mx06 (fcrs = mx006) novartis farmacéutica s.a. de c.v.
Functional area
quality
job type
full time
employment type
regular
shift work
no
*accessibility and accommodation*:
novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.