Quality Specialist

at  Almac Group

REQUIRED EDUCATION:

Bachelor’s Degree in Sciences or related discipline
Preferred Education: n/a

REQUIRED WORK EXPERIENCE:

A minimum of one year experience in a Quality role within the pharmaceutical manufacturing industry
A minimum of one year experience working in an analytical laboratory within the pharmaceutical manufacturing industry
A minimum of one year experience reviewing and approving cGMP documents.
A minimum of one year experience managing multiple projects simultaneously

PREFERRED EXPERIENCE:

Previous experience within a cGMP/pharmaceutical environment
Previous experience generating or reviewing analytical documents
Prior experience generating or reviewing instrument maintenance, qualification, and validation documentation.
Prior experience in conducting internal audits or other quality compliance activities
Understanding change requests

REQUIRED KNOWLEDGE:

It is essential to have knowledge of a Quality System involving generation or review of analytical documentation and cGMP
Safe laboratory practices

PREFERRED KNOWLEDGE:

Knowledge of the drug development life cycle
Analytical chemistry, drug substance and drug product
Instrument maintenance, qualification, and validation
Skills:
Excellent organizational and time management skills
Excellent verbal and written communication skills are also essential attributes for this position
Excellent attention to detail
Ability to perform multiple project tasks and meet required deadlines
Ability to be detail-oriented with an emphasis on accuracy and delivery of high quality projects

Additional Qualifications: [examples]

• Customer service/client relations
• Communication proficiency
• Attention to detail
• Can work productively independently with minor supervision
• Self-motivated, flexible, dependable and available
• Excellent organizational and time management skills

ESSENTIAL FUNCTIONS:

A. Perform day-to-day QVT (Quality Validation Team) duties to support the Almac Sciences Quality Management System including:
Support QVT by maintaining and scheduling the onsite/external maintenance and calibration of instruments
Liaison with equipment engineers/technicians that come onsite
Package and dispatch of instrumentation to offsite vendors for calibration, service or repair
Author, scan, file, and archive equipment maintenance, validation and analytical documentation
Ensure that the validation status of Analytical Equipment, Instrumentation, Facilities and associated Software is maintained in accordance with cGMP and other regulatory standards, at all times.
Assist QVT and QA in the handling of reviewed documents
(80%)
B. Perform day-to-day QA (Quality Assurance) duties to support the Almac Sciences Quality Management System including:
Manage the document control requirements of the Document Control Matrix (DCM) and manage archival of GMP documents
Review and approve documents associated with assigned projects including the final release of data to customers
Review and approve document change requests as required. This will include final approval of the associated documents
Generation of KPI data for Quality Metrics
Represent Almac Sciences, Souderton to customers including customer audits, technical visits and conference calls. This may also include representation at Regulatory Inspections (FDA)
(20%)