agap2
is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors. As a consultant , you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills. You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio. Your main responsibilities
Drive
continuous improvement
of the
GMP quality system
for
Fill & Finish , ensuring
inspection readiness Support
batch release
through rigorous
review of batch records
and manufacturing documentation Review and approve
GMP documents
( SOPs, protocols, reports ) related to
aseptic processes and equipment Act as
SME
for
process validation
and
equipment qualification
( URS, FAT/SAT, IQ/OQ/PQ ) Lead
investigations
( deviations, CAPAs, OOS, complaints ) using a
risk-based approach Manage
change controls
impacting
processes and systems Ensure oversight of
aseptic operations
( media fills, CCS ) Oversee
qualification and lifecycle
of
Fill & Finish equipment
(filling lines, isolators, lyophilizers) Manage
CMO quality oversight
and external partner performance Contribute to
APQR
and support
audits and inspections
as
SME Your profile
Master’s degree
in
Pharmacy, Engineering, Biotechnology, or Quality 3–8 years of GMP experience
in
pharma/biotech Strong expertise in
Fill & Finish
( aseptic processing, sterile manufacturing, equipment qualification ) Good understanding of
USP, DSP, Fill & Finish Solid knowledge of
cGMP
( EU GMP, FDA ) Experience in
aseptic environments
( isolators, cleanrooms, CCS ) Background in
validation/qualification activities Strong
analytical, communication, and stakeholder management skills Comfortable in a
cross-functional, international environment Fluent in English and German (mandatory)
#J-18808-Ljbffr
is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors. As a consultant , you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills. You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio. Your main responsibilities
Drive
continuous improvement
of the
GMP quality system
for
Fill & Finish , ensuring
inspection readiness Support
batch release
through rigorous
review of batch records
and manufacturing documentation Review and approve
GMP documents
( SOPs, protocols, reports ) related to
aseptic processes and equipment Act as
SME
for
process validation
and
equipment qualification
( URS, FAT/SAT, IQ/OQ/PQ ) Lead
investigations
( deviations, CAPAs, OOS, complaints ) using a
risk-based approach Manage
change controls
impacting
processes and systems Ensure oversight of
aseptic operations
( media fills, CCS ) Oversee
qualification and lifecycle
of
Fill & Finish equipment
(filling lines, isolators, lyophilizers) Manage
CMO quality oversight
and external partner performance Contribute to
APQR
and support
audits and inspections
as
SME Your profile
Master’s degree
in
Pharmacy, Engineering, Biotechnology, or Quality 3–8 years of GMP experience
in
pharma/biotech Strong expertise in
Fill & Finish
( aseptic processing, sterile manufacturing, equipment qualification ) Good understanding of
USP, DSP, Fill & Finish Solid knowledge of
cGMP
( EU GMP, FDA ) Experience in
aseptic environments
( isolators, cleanrooms, CCS ) Background in
validation/qualification activities Strong
analytical, communication, and stakeholder management skills Comfortable in a
cross-functional, international environment Fluent in English and German (mandatory)
#J-18808-Ljbffr
