Senior QA Specialist for Finished Product/Combination products and Clinical will
be responsible, with management support, for providing oversight of quality activities
associated with the Finished Product Packaging Combination products and
clinical activities at ADMF. The incumbent will be responsible for quality
oversight of the Packaging and storage of Finished Product (Combination
products and clinical) completed internally at the College Park facility.
He/she is responsible for ensuring that testing, packaging, labeling, validation/verification
and storage of the company products comply with all applicable regulations. This
responsibility includes the oversight of the College Park QMS to ensure that
quality and compliance requirements are followed in line with business needs.
· Responsible for Quality
oversight, with management support of internal packaging, warehousing
operations combination products, clinical, validation verification and quality
control at College Park.
· Co-ordinate the QA Finished
Product team and liaise with peer internal Quality Groups to ensure on-time
disposition of Finished Product.
· Provide Quality support to QC
department to include method transfer or validation/verification activities and
LIR review and approval.
· Provide oversight to continuous
quality system improvements and support implementation of improvements at College
Park in compliance, calibration ,Preventive Maintenance, Deviation Management
and the Change Control Programs.
· Perform batch documentation
review, management of changes, complaints, deviations, validations and product
annual reviews related to College Park operations.
· Provide QA and compliance
support to projects impacting on College Pack packaging activities.
· Provide support and expertise
for inspection readiness activities, during health authority inspections
including interaction with inspectors, responses to inspection observations, to
monitor progress of follow up actions.
· Responsible for quality review
and approval of Master Packaging Batch Records in accordance with the company’s
internal procedures and GMP principles.
· Review and approval of standard operating procedures and controlled documents.
· Define and follow-up standard
quality KPI and to review quality indicators with recommendation for actions
for improvement in relation to packaging operations.
Minimum 5 years in
international pharmaceutical and/or biotech industry with increased level of
· Minimum 3 years of experience
in QA labeling and packaging/combination products and/or QC
· Sound awareness and
understanding of pharmaceutical business, especially with regards to quality
and regulatory requirements
· Demonstrated success records
in auditing and improvement processes
· Ability to operate efficiently
in a complex matrix organization and international environment
· Management skills for
management of a team of experts,
· Strong mature leadership and
interpersonal influencing skills
· Ability to represent the
company and to negotiate at different levels contacts both internally and
· Strong verbal and written
communication skills with well-structured communication and presentation
ability to various audience levels
· English fluency written and
spoken (the Company language)
· Efficient in SAP, firstdoc.
Academic degree in natural or
applied sciences (Pharmacy, chemistry, biotechnology, engineering)