API – Engineering and Maintenance (Mechanical & Electrical)
API – Instrumentation
API – QUALITY CONTROL
API – QUALITY CONTROL – SPECIAL INSTRUMENTS GROUP
Date: Saturday 30th Nov, 2019 (9:00AM- 1:00PM)
Venue: Biocon Limited, Plot No: 02, Road No:21, J.N.Pharmacity, Thadi Village, IDA Paravada, Visakhapatnam-531019
Mechanical Maintenance:
Qualification: Diploma(Mechanical) / B.E or B. Tech(Mechanical)
Experience: 1 to 10 years
Work Location: Vizag
Job Description:
Preventive , Predictive and breakdown maintenance for the equipment’s like Fermenters, NDV, Decanter, Reactors, Centrifuges, Vacuum tray dryer, HPLC, RCVD, AJM and other equipment’s
Solvent pumps, Day tanks and actuated valve maintenance
Knowledge in equipment qualification DQ, IQ, OQ
Knowledge in area qualification and validation
Experience in brown field project activities
Should have knowledge in HVAC system
Knowledge in MTBF, MTTR
SAP PM module working knowledge is an added advantage
Instrumentation:
Qualification: BE, Btech in ECE, I&C, E&E (OR) Diploma in same specialisation
Experience: 1 to 10 years
Work Location: Vizag
Job Description:
Trouble shooting and calibration of process instruments like pressure , flow , level, temperature and analytical transmitters
Knowledge in programming and trouble shooting in Rockwell PLC family, Siemens, ABB and Delta V process automation system.
Working knowledge in Zone 0 and Zone 1 area instruments and workstations.
Knowledge in control system, Equipment qualification with DQ, IQ and OQ.
Preventive maintenance of control system panels
Knowledge in VFD programming and communication protocols.
SAP PM module working knowledge is an added advantage
Electrical Maintenance:
Qualification: B. E or B. Tech(Electrical) / Diploma(Electrical)
Experience: 1 to 10 years
Work Location: Vizag
Job Description:
Preventive , Predictive and breakdown maintenance for the equipment’s like Fermenters, NDV , Decanter , Reactors , Centrifuges , Vacuum tray dryer and other equipment’s
Electrical maintenance and troubleshooting activities with respect to Zone 0 and Zone 1 classified area.
LT panel , ACB , Motor and LT cable maintenance
Working knowledge in starters, Control wiring and variable frequency drives.
Knowledge in equipment qualification
Knowledge in area qualification and validation
Should have knowledge in HVAC system
Experience in brown field project activities
Knowledge in MTBF , MTTR
SAP PM module working knowledge is an added advantage
API – QUALITY CONTROL
QUALIFICATION: M. SC(CHEMSITRY) / M. PHARM
EXPERIENCE: 2 TO 10 YEARS
Work Location: Vizag and Hyderabad
Job Description:
Raw material, In Process samples and finished product inspection/ testing/ approval.
Production process control in coordination with Production.
Product traceability - Reserve Samples.
Customer complaints relating to quality of the product.
Identification recording and evaluation of all Nonconforming products.
Corrective and preventive actions as and where applicable.
Adherence to Product Specifications and Good Laboratory Practice
Maintenance and Calibration of Measuring and Testing Equipment/ Instrument belonging to the Quality Control Laboratory in coordination with Maintenance Department.
Preparation/ Review and maintenance of Product specifications, Analytical reports and Quality Records.
Review of cleaning validation/ Process validation protocols.
Issue of Raw data book/ Checklists/ log sheets for record entries.
Updation of Stability protocols and calibration records of all Laboratory Equipment/ Instruments.
Investigation of OOS results.
API – QUALITY CONTROL – METHOD VALIDATION TEAM
QUALIFICATION: M. SC(CHEMSITRY) / M. PHARM
EXPERIENCE: 2 TO 10 YEARS
Work Location: Vizag
Job Description:
To collect samples and to carry out all tests and to issue test reports as per documented procedures.
Adherence to Good Laboratory Practice
Method transfer from RND and other sites.
Maintenance and Calibration of Measuring and Testing Equipment belonging to the Quality Control Laboratory in coordination with Maintenance Department.
Generation and maintenance of Quality records.
Preparation and adherence to Product Specifications.
Analysis of validation samples.
Analysis of XRD and In process samples and documentation of the same.
Preparation of Cleaning validation/ Process validation protocols and report.
Preparation and Review of Analytical method validation documents.
Preparation and Review of Analytical reports.
Change control, deviations, and CAPA related documentation.
Training of personnel in Quality Control and maintenance of training records.
Investigation of Laboratory incidents and OOS/OOT results.
Preparation and review of Instruments and equipment qualification protocols and reports.
Execution of Instruments and equipment qualification.
Trouble shooting of LC and GC related issues.
Troubleshooting of other analytical instruments and equipment in the laboratory.
Preparation and adherence to Product Specifications.
Qualification, standardization, Re-standardization and Maintenance of working/laboratory standards, impurity standards, and analytical standards required for the laboratory.
Instrument qualification and software qualification related activities.
To install Training as a part of Annual Periodic Training.
Co-ordination with cross functional teams to meet the project timelines.
API – QUALITY CONTROL – SPECIAL INSTRUMENTS GROUP
Qualification: M.Sc, Chemistry or M.Pharm (Pharmaceutical Analysis)
Experience: 3-10 years in API or Drug product QC or Analytical R&D
Work Location: Bangalore and Vizag
Job Description:
Should have hands-on experience in the analysis using instruments, viz. LC-MS/MS, ICP-MS, XRD and IC
Practical knowledge on the qualification and calibration of mass spectroscopy, XRD andIC instruments.
Should have executed the Analytical Validation of LC-MS/MS, ICP-MS, XRD and IC methods
Exposure on common analytical/QC instruments including handling of chromatography (HPLC/GC) techniques.
Well-versed in the Good documentation/laboratory practices and GMP concepts/regulatory guidelines.
Exposure in the preparation of SOPs, Test procedures, protocols and report.
Should have good communication and troubleshooting skills.
Candidates should bring two passport size photos, two copies of their CV, payslip, copies of educational certificates, previous work experience certificates & salary annexure.
For queries kindly reach out to Pulla Rao - pullarao.yarramsetti@biocon.com
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