*summary*:
conduct and support glp/gclp audits, including integrations and non-gxp assessments, following the novartis quality system and current regulations. Ensure compliance with applicable standards and guidance documents. Review and approve corrective action plans for audit observations.
*about the role*:
*major accountabilities*:
- support the strategic development of an effective global risk-based audit strategy and program; collect, collate, and incorporate input into audit strategy and plan.
- lead, plan, conduct, document and follow-up of global quality regulatory compliance audits of glp/gclp according to the requirements specified in the respective novartis quality module. Assess the adequacy of responses (capa plans) to audit findings.
- conduct assessments for companies and their vendors during bd&l integration activities including non-gxp assessments, which include, but not limited to data reviews, it system evaluations.
- provide technical guidance, leadership, mentoring and training of other auditors on audit related activities.
- ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures accordingly.
- identify and communicate quality and regulatory compliance issues to quality management and recommend remediation.
- liaise as needed with the third-party management team.
- proactively research local and global initiatives, trends and events that impact maintenance of compliance. Maintain current knowledge of regulations, standards and guidance documents.
*key performance indicators*:
- complete audits/assessments promptly and accurately.
- ensure findings and reports meet timelines, procedures, and key quality indicators (kqis).
- analyze audit metrics and non-compliance causes effectively.
- escalate issues through proper channels promptly.
- communicate and support business partners thoroughly and accurately.
*minimum requirements*:
*work experience*:
- 7+ years of glp/gcp/pharmaceutical industry/health authority experience or equivalent.
- 5 years of gcp/pv auditing experience
*skills*:
- ability to independently manage and objectively evaluate complex compliance issues with mínimal supervision.
- experience with health authority inspections
- excellent verbal and written communication, organizational and interpersonal skills.
- knowledge of applicable gxp regulations, guidelines, policies, and procedures.
- good knowledge of computer systems validation and 21cfr part 11 requirements.
- leadership and facilitation skills
- international travel expectation 25%.
*languages*:
- english.
Division
biomedical research
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.