Quality Assurance Specialist

Description

Quality Assurance Specialist

Our client, a leading pharmaceutical organisation is currently seeking a
Quality Assurance Specialist:

Location: Basel area
Duration: 6 month which might be extended
Start: ASAP


Job Duties/Responsibilities

• The Quality Assurance Specialist will assist in the preparation of
release packages for approval by the Manager of Lot Disposition
and within established standard lead times. This work contains
review of batch records, deviation reports, chromatograms, batch
reports and other quality records to support the lot release of
commercial bulk products.
• Report any issues, deviations, investigations or trends discovered
during the lot review to Genentech quality management for review
and approval per Genentech policies and procedures.
• Work on other projects to support quality managers as needed in
administrative work, Quality Risk Assessment, Audit tracking and
closure, support of regulatory filings, commissioning, annual
product quality reviews, change control, metrics and other possible
areas.
• Interact on an ongoing basis with site quality managers to solve any
quality issues.
• Support the transport, storage and archiving of paper and/or
electronic quality documents from the PTQXA manufacturing sites.


Technical Duties/Responsibilities:

• Management of batch record review activities to ensure that
products are dispositioned in accordance with regulatory
requirements, cGMP’s and Genentech/Roche policies and
procedures, within standard lead times.
• Interfacings with appropriate departments or manufacturing
plants to ensure that lot disposition items are completed.
• Notification to Senior Management for all known delays in
meeting established standard lead times or any potential quality
issues.
• Interfacing with QA Lot Disposition Supervisors to ensure that
final review activities are completed.
• Performing a review of investigations for potential cumulative
effect to a batch history record.
• Performing a review of QC discrepancy reports, action limit
excursions, assay variances, and anomalous results reports for
potential correlation to the respective batch history record.


Qualifications:

• BS/BA or laboratory assistant in life sciences or equivalent.
• 2-5 year's pharmaceutical experience in manufacturing,
quality assurance or quality control.
• Lot review or batch release experience in biotech/pharmaceutical
operations.
• Must be capable of applying cGMP concepts and
requirements to evaluate product disposition using sound
judgment and decision-making skills.
• Knowledge of cGMP’s (Drugs and Biologics), and
regulations applicable to U.S. and international Regulatory
agencies.
• Excellent communication skills, verbal, and written.

Languages:

• Excellent in English and German, French would be
desirable