Job openings Engineering Quality Assurance @ Biocon Department: Quality Assurance (Engineering) Qualification: M.Pharm in Any Specialization, MS/M.Sc (Science) in Any Specialization Experience: 10 – 15 years Location: Bangalore Openings: 02 Job Description:
Well versed with pharmaceutical QMS systems at par with international regulatory requirements.
Conversant in handling Quality System apex documents like Site Master File, Validation Master Plan and Quality Manual.
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.
Hand on experience in Qualification and validation of equipment, utilities, facility and systems with team management capability
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.
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.
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.
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.
Well versed with handling the qualification and validation activities for green filed project management.
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
Experience in corporate quality assurance for reputed organisations with hands on experience of digital technology in manufacturing quality system management is a plus.