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QA Senior Specialist / External Manufacturing H / F

ALBEDISBoudry, Neuchâtel, CH

Vor 15 Tagen

Stellenbeschreibung

INTRODUCTION :

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+

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.

PROFIL ATTENDU :

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.