Laboratory Investigator

Job Description

Laboratory Investigator

PURPOSE:

The Analytical Laboratory Investigator is responsible for reviewing the completeness, accuracy and cGMP compliance of the data and documentation generated in the Quality Control laboratory. The position requires a strong knowledge of analytical testing in a cGMP Quality laboratory, good interpersonal skills and time management.

SUPERVISORY RESPONSIBILITIES:

• Work in collaboration with responsible to the complaints and deviations departments.
• Responsibility for writing a detailed report on the analysis of the complaints, review and approve deviation reports.
• Training and qualification of new employees in job duties according to Standard Operating Procedures (SOP), current Good Manufacturing Practices, (cGMP) and Company training procedures
• Requires review, approval, and on time closure of the investigation
• Reviews and approved Finished Products/ Raw Materials Certificate of Analysis and other relevant documents.
• Improving processes related to complaints and deviations.
• Implementation of corrective actions, CAPA and CAPA Effectiveness management.
• Making decisions in real time according to the organization's procedures.
• Overall responsibility for the quality of the company's products.
• Work with many different interfaces in Israel and abroad.
• Work in compliance with quality KPIs and goals in accordance with the organization's requirements.
• Handling and approval investigations related to validation batches deviations and Out of Specification / Out of Alert Limit / Atypical results during stability study running.
• Ensure proper Corrective and Preventive Actions implementation and Effectiveness Checks in relevant topics.
• QA support, handling and approve activities related to new products introduction.
• Support regulatory inspections during preparation and execution.
• Strong understanding, knowledge and working according to cGMP, Corporate and Site SOP requirements
• Review, evaluate and approval of product specifications, product’s manufacturing and packaging master documentation, stability protocols.
• Assessment and approval of product validation and/or characterization protocols and reports.
• Evaluation, task managements and approval Change Control Requests for Raw and Packaging Materials, Product’s pre and post approval changes, production and packaging documentation changes etc

MAJOR DUTIES AND RESPONSIBILITIES:

• Responsibility for handling complaints and deviations
• Responsible for managing Customer Complaints and Site Deviations.
• Ensure performs and approve comprehensive investigations of manufacturing and laboratory Out of Specification / Out of Alert Limit / Atypical results related deviations, root cause analysis and quality impact assessments. Evaluates impact and recommends final disposition of product/batches involve
• Act as a Subject Matter Expert during regulatory and internal audits.
• Responsible for meeting business demands with respect to release testing of parenteral drug products.

SKILLS AND ABILITIES:

• Responsibility for handling complaints and deviations
• Maintain a culture of enhancing quality throughout the entire Laboratory Performance of in-depth root cause analyses and problem solving.
• Experience and knowledge in analytical methods for glycoproteins. Experience and in particular in HPLC/UPLC, MS(advantage)
• Basic knowledge in GLP/GMP guideline

EDUCATION AND EXPERIENCE:

• Masters’ or Ph.D degree in Chemistry/pharmaceuticals sciences/Biology/Life Science or any other relevant degree.
• 3+ years proven experience in pharmaceutical industry; QA background.
• Strong communication/interpersonal skills.
• Strong analytical mindset, attention to details.
• Proficient using computerized systems, including Microsoft Office applications.
• High English level.

Preferred Additional

• Good teamwork capabilities.
• Pharmaceutical/Bio Pharmaceutical laboratory experience is required.