QA Project Manager II_CH

Maternity Leave Replacement.
General QA functional responsibilities:
Support continuous improvement programs to establish an effective Quality Management
System.
Represent Quality Assurance in cross-functional teams, establish and maintain interfaces
with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering
project / technology transfer to effectively execute tasks related to Drug Product
processes.
Assess, review and approve quality records e.g. deviations, change control, CAPAs,
investigations, effectiveness checks, extensions in line with current local SOPs.
Author, review and approve GMP-relevant documents and SOPs.
Responsible to present Drug Product QA topics during the conduction of all customer
audits and regulatory inspections within DP.
Participate in internal audits as required by the organization.
QMS : Organize and manage monthly Quality Council & Risk Register
KPI reporting Tracking of key Quality indicator on a monthly basis in QA staff meeting
Monthly update of FLYING CARPET of Quality related KPIs.
Gap Assessment for HA/Audit obs at other MODULES/Lonza facilities
Tracking and follow-up on daily update of HOSHIN Tier 1 and Tier 2
Back-up of Head of QA DPS in daily HOSHIN 2
(B) Project-specific QA functions within Drug Product:
Act as point of contact for Drug Product QA related questions and issues related to the
manufacturing operations.
Support and approve project / product specific risk assessments.
Review and release product specific documentation such as process descriptions and
workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter
lists, etc.
Review and approve executive batch records, prepare batch release for the responsible
person (FvP), including recommendation on disposition status.
(C) QA responsibilities for customer contact:
Customer contact in regards to QA topics. Support and manage interactions in cases of
changes, deviations, technical complaints, out of specification results and others
(D) QA responsibilities for Release:
Delegate of FvP for Batch Disposition of DP.
Delegate of the FvP for conditional release according to CHVI-4553 and CHVI-265873
"Zuständigkeiten von Sonderfreigaben".

Contact: Alba Jansa

Whatsapp Business: +41 76 811 63 99