Openings for Engineering Quality Assurance @ Biocon
Limited
Job description
1) Well versed with
pharmaceutical QMS systems at par with international regulatory requirements.
2) Conversant in
handling Quality System apex documents like Site Master File, Validation Master
Plan and Quality Manual.
3) Should have
expertise specifically in API (synthetic and semi synthetic) and OSD
facilities. Additionally, experience in sterile manufacturing quality assurance
specific to engineering project management is preferred.
4) Hand on
experience in Qualification and validation of equipment, utilities, facility
and systems with team management capability
5) Versed with
qualification and validation (URS, DQ,IQ,OQ,PQ) of equipment in API, OSD and
sterile manufacturing. Preferred to have synthetic and semi synthetic
(fermentation) manufacturing operation expertise. Conversant with peptide
(Synthetic and recombinant methodology) manufacturing facility is recommended.
6) Shall be versed
and having hand on expertise in design, qualification/validation (URS,
DQ,IQ,OQ,PQ) and routine operation management of utility system like water
systems (pre-treatment- Raw water treatment, Potable Water, Purified water and
WFI), HVACs (all grades as per ISO classification), Nitrogen systems (Plant
nitrogen, external supplies-cylinder and liquid nitrogen), compressed air.
7) Shall have
expertise in Computer system validation specific to all categories of systems
as per GAMP guidelines. Well versed with practical qualification approach of 21
CFR part 11 and EU annex 11 requirements.
8) Well versed with
digitalisation of manufacturing systems specifically management of computerised
system like PLC, SCADA, DCS, MES and integration approach with SAP, LIMS, DMS
etc.
9) Well versed with
handling the qualification and validation activities for green filed project
management.
10) Good personal
and professional management skills for coordinating with different teams across
departments the group at corporate level for smooth handling of timely project
execution
11) Experience in
corporate quality assurance for reputed organisations with hands on experience
of digital technology in manufacturing quality system management is a plus.
Experience: 10-15
yrs
Location: Bangalore
Openings: 02
Qualification: M.Pharm
in Any Specialization, MS/M.Sc (Science) in Any Specialization
Interested kindly share profiles
on prasad.n101@biocon.com / /anita.pachorkar101@biocon.com
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