QA Senior Specialist / External Manufacturing H/F

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.

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