Work as Process Lead at Arco Lab Private Limited
Arco Lab Private Limited is a Private incorporated on 20 August 2018. It is classified as Non-govt company and is registered at Registrar of Companies, Bangalore. Its authorized share capital is Rs. 2,500,000 and its paid up capital is Rs. 1,600,000. It is inolved in Business activities n.e.c. Arco Lab Private Limited's Annual General Meeting (AGM) was last held on N/A and as per records from Ministry of Corporate Affairs (MCA), its balance sheet was last filed on N/A.
Post : Process Lead
Key Skills
Analytical compliance
• Review and ensure OOS/Deviations are investigated and appropriate CAPA's are identified and implemented
• Perform CLP checks in laboratory to provide inputs for improvements
• Review & identify areas of improvement in the analytical laboratories and procedures at plants
• Ensure all instruments/ equipment's & associated software's are meets the 21 CFR-Partll compliance
• Online review and approval of chromatographic /system suitability review sheet and approval of invalidated data
• Perform the audit trail verification of all instruments in Quality Control units for accuracy, correctness and completeness of analytical data
Manufacturing Assurance
• Experience in review of BMR. BPR and other manufacturing documents
• Good knowledge and experience in handling process validation and cleaning validation
• Experience in handling IPQA activities.
• Experience in handling Qualification of equipment's facility and utility
• Experience in handling of investigation and other QMS events
• Knowledge on CXP/21CFR/ 21 CFR PART 11 compliance/Risk assessment.
Engineering Assurance
• Experience in handling utility system like HVAC - clean room, water system. Compressed air. Boiler and statutory requirements etc
• Experience in handling of investigation and other QMS events.
• Good knowledge and understanding of electronic compliance.
• Experience in checking audit trail, print report, alarms, interlocks, data integrity, data backup & restore etc
• Knowledge on GXP/21 CFR/ 21 CFR PART 11 compiiance / Risk assessment
QA Compliance
• Review and identify areas of improvement
• Review and ensure all QMS events are dosed on time.
• Review and ensure that Stability Study Programme conducting as per the procedure.
• Review and ensure that reserve samples are Evaluating, maintaining and stored as per the procedure
• Review and ensure effectiveness of CAPA
Qualification : M. Pharmacy / B.Tech or M. Tech / M.Sc.
Work location : Bangalore, Chennai & Pondicherry
Experience : 8-10 Years
Walk in time: 10 AM -12 PM Date: 14th & 15th December 2019
Venue: Aditya Park- A Sarovar Portico Hotel Aditya Trade centre, Telangana
Contact: Ashima Choudhary
ashima.choudhary@arcolab.com
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