Lavipharm is seeking a Quality Assurance Lead, who will be responsible for overseeing and leading the Quality Assurance team and day to day plant operations, in accordance with Good Manufacturing Practices (cGMP) and regulatory requirements.

Responsibilities

Quality Oversight and Compliance

• Complies with Company policies, operating procedures, processes and task assignments

• Supports all Company initiatives as identified by management and other regulatory requirements

Process Improvement

• Identifies opportunities for enhancing quality systems and processes and implementing improvements, without compromising product quality

• Actively participates in new projects, provides quality support and follows up to all required quality tasks

Cross-functional Collaboration and Communication

• Ability to lead, mentor and manage QA teams, ensuring alignment with company goals

• Serves as a liaison for the compliance team to other functional groups

• Keeps team informed on all upcoming projects, providing updated information, action plan explanation and delegation of related tasks

Documentation and Reporting

• Ensures the defect tracking system is effectively capturing and managing defects

• Reviews and approves risk assessment protocols and amendments (including risk assessment for elemental impurities and nitrosamines)

• Approves the discrepancies' investigation results detected in the plant and their final closure in collaboration with Manufacturing Management

• Approves all customer complaint investigation results

• Controls and evaluates the Recall system, while approving virtual recalls, in accordance to relevant procedures

Audit Strategy

• Monitors the implementation of on-site audits by external stakeholders, ensuring ethical standards, adherence to audit guidelines and regulatory requirements

• Runs audits of suppliers/vendors to assess their quality systems and ensures that they meet the organization’s standards

• Master of Science (MSc) in Pharmaceutical, Biomedical Science, Medicine, Chemistry or Mechanical Chemistry

• At least 8 years' experience in a managerial position, in the Pharma industry within the quality function

• Excellent Knowledge of the English language

• Computer Literacy (MS Office etc)

• Good numerical skills and an understanding of statistics

• Leadership skills

• Communication and interpersonal skills

• Problem-solving skills

Required Know-how:

• Auditing experience per ISO and EU standards

• Knowledge of a variety of Pharma, Combination Product regulations

• Knowledge of Pharma manufacturing operations