QA Specialist

Major accountabilities:

• ·       Assure the respect of the GMPs and Health Authorities requirements at local level.

  ·       Contribute to maintain the local quality system as per GMPs and corporate guidelines.

  ·       Redaction and review of SOPs, records, protocols and reports according to GMPs, National/ Corporate Guidelines and health authorities’ requirements.

  ·       Registration and archive of the documentation at local level.

  ·       Manage the GMP logbooks (distribution, archiving and revision).

  ·       Collaborate in the management of Annual Product Reviews (redaction and review).

  ·       Manage of training records, execution at local level of staff GMP training and redaction of the Training Annual Plan.

  ·       Support the Quality Site Head during escalation case in case of critical issues occurred.

  ·       Participate to the self-inspections as per approved annual plan and to the external audits (Health Authorities, Certified Bodies, Supplier).

  ·       Support in management and redaction of Out of Specifications, System Suitability Test failure, Out of Trend, Deviations, CAPA, Change Controls, Complaints according to cGMP and reference SOPs.

  ·       Collaborate in the annual suppliers’ qualification in accordance with related SOPs.

  ·       Fill in the KQIs files.

  ·       Prepare and print the batch documentation.

  ·       Support the QPs in the batch record review.

  ·       Support at local level the QA Department: 

  o   in assuring the execution of qualification, maintenance, calibration and revalidation programs;  

  o   in managing the external inspections follow up;  

  to follow the training annual plan.

Key performance indicators:

• Inspection management (no critical observations during Health Authorities inspections).

  Completion of all relevant quality records within applicable time frame, with measured overdues.

Minimum Requirements:
Work Experience:

• Functional Breadth.
• QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
• Collaborating across boundaries.
• cleanliness zones.

Skills:

• Continuous Learning.
• Dealing With Ambiguity.
• Gmp Procedures.
• Qa (Quality Assurance).
• Quality Control (Qc) Testing.
• Quality Standards.
• Self Awareness.
• Technological Expertise.
• Technological Intelligence.

Languages :

• English.

Education:      Pharmaceuticals, Chemical or biological degree 

Languages:     Fluent English verbally and in writing 

Experiences:

• 1+ years of experience in a Quality dept. 
• Strong affinity with and awareness of quality issues 
• Good organizational skills including attention to details  
• Knowledge of quality system (GMP)  
• Basic knowledge of regulatory requirements 
• Shows the appropriate sense of urgency around given tasks
• Work in team