Quality System Officer
Norgine, United Kingdom

MAIN PURPOSE :

Manage and coordinate operational activities of External Network (EN) department in support of the Quality System Team.

KEY RESPONSIBILITIES amp; ACCOUNTABILITIES:

• Support Senior Quality officer (SQO) as back up for quality management system
• Support SQO as back up for management and maintenance of quality system: CAPA, deviations, change control
• Support and back up for SQO in preparing and communicating the monthly KPIs to global and in coordinating and leading the monthly quality meeting when required
• Lead or support the reporting of the NQC metrics

• Lead and represent quality in specific projects

Quality operations within EN

• Support compliance and continuous improvement projects for EN

Quality Management System

Documentation Management

• Ensure compliance of procedures written by EN with Norgine standards and author quality SOPs to support business requirements

GMP Compliance and training

• Support the training of EN/NBV staff in accordance with global amp; local requirements
• Lead or support training sessions relating to GMP amp; procedures adapted to EN/NBV

Coordinate partner follow-up activities

• Keeping the list of partners and their status up to date
• Lead and prepare the Partner Performance Review and Management Review each year

KEY COMMITTEE MEMBERSHIPS:

Quarterly EN quality meeting

RELATIONSHIPS:

• Reports to Senior Quality Officer
• Interact with Norgine Quality Officers
• Interact on a daily basis with Supply and Quality Product Portfolio Managers
• Interaction with Norgine BV QPs and EN Quality Director
• Support and represent the EN organisation inside Norgine
• EN Quality representative in global projects according to the needs of the department

KNOWLEDGE amp; SKILLS:

• Scientific degree
• 3 years’ experience in Pharmaceuticals including experience in QA
• Knowledge of the Quality amp; Regulatory requirements of the pharmaceutical industry
• Knowledge of GMP and GDP
• Excellent verbal amp; written communication skills
• Excellent influencing skills and ability to establish effective working relationships with personnel at Norgine
• The ability to present effectively to groups
• Fluency in English language is essential

Job Rewards and Benefits