QA Senior Specialist / External Manufacturing H/F
Infos sur l'emploi
- Date de publication :16 décembre 2024
- Taux d'activité :100%
- Type de contrat :Temporaire
- Lieu de travail :Areuse
For a major pharmaceutical company in the Neuchâtel area, we are looking for a 12-month temporary contract for two positions as :
QA Senior Specialist / External Manufactoring H/F
English - French & German a+
QA Senior Specialist / External Manufactoring H/F
English - French & German a+
DESCRIPTION DE LA MISSION
As a QA Specialist, your main responsibilities will include:
Vendor Quality Management :
- Overseeing contractor quality assurance activities to ensure manufacturing, packaging, testing, release, and distribution processes comply with regulatory and corporate requirements.
- Building and maintaining strong working relationships with external partners and leading quality-related discussions (e.g., deviations, OOS, complaints, and change controls).
- Recommending and supervising the implementation of process improvements.
- Reviewing and approving critical documents, such as batch records, validation protocols, and investigation reports.
Quality System Management :
- Managing change control processes, including initiation, evaluation, monitoring, and escalation as needed.
- Supporting customer complaint investigations related to external vendors and approving investigation outcomes.
- Reviewing and enhancing contractor Annual Product Quality Review (APQR) reports and drafting or reviewing quality agreements with external partners.
Audits and Inspections :
- Participating in internal audits and external audits of manufacturing and distribution sites.
- Supporting regulatory inspections (e.g., FDA, EMA).
System Improvements and Compliance :
- Developing and maintaining pharmaceutical quality systems in line with global standards.
- Ensuring personal training compliance and updating Standard Operating Procedures (SOPs) as needed.
To excel in this role, you bring :
- A degree in a scientific discipline (BSc or equivalent).
- At least 5 years of experience in Quality Assurance within the pharmaceutical industry.
- Comprehensive knowledge of cGMP/GDP regulations applicable in the USA, EU, and international markets.
- Proven experience in interactions with external manufacturers and regulatory agencies (e.g., FDA, EMA).
- Strong project management, communication, and problem-solving skills.
- Proficiency in computer systems and tools.
- Languages : English & French proficient / German is a plus
Key Attributes :
- Ability to balance business objectives with scientific and quality-driven decisions.
- Excellent organizational and interpersonal skills.
Additional details :
- Position is site-based with occasional travel required.
- May act as a delegate for the QA Manager or Associate QA Director as needed.
