Sr.officer (qc Department) Job in Atra Pharmaceuticals Limited

Direct Reporting : Manager (Finished Product /Stability Study Section)

Location : Aurangabad, MH India

Requirements : Master of Science in Chemistry / Bachelor of Pharmacy

Experience : 3 to 4 Years Experience in Quality Control Department within the Pharmaceutical Industry

Skills Required

• Should hand s on High Performance Liquid Chromatography instrument and good testing knowledge about Finished Product Analysis and Stability Samples
• Should hand s on review of analytical raw data of Finished Products and Stability study sample analysis
• Exposure in Handling of QMS documents like, OOS, OOT, Lab Incidents and Change Control, Deviations.
• Motivated, dedicated, hardworking and result oriented
• Able to work with the various stakeholders within the Company and Group
• To carry out analysis of Semi-finished and Finished products. Also process validation samples, stability samples as well as Rinse / Swab samples on HPLC System as well as by chemical and physical parameters testing.
• Review of analytical raw data of Finished Products and Stability study sample analysis
• Handling of QMS documents like, OOS, OOT, Lab Incidents and Change Control, Deviations.
• Responsible for receipt of samples with intimation & entering in the Respecting logbook
• Give the requisition for test data sheet and other QC documents for issuance
• Responsible for testing of Finished products/In process/semi-finished/Hold time study sample/Validation sample analysis as per respective STP and Specification and reporting online
• Responsible for maintaining the all the records of analysis
• Responsible for handling and storage of standards and samples as per laid down SOP and relevant documentation
• Responsible for On-line documentation and reporting
• Responsible for ensuring that all laboratory activities are carried out in compliance with the existing SOPs
• Responsible for implementation of training received in laboratory activities
• Responsible for ensuring that all activities carried out in the laboratory is in compliance with GMP / GLP / Safety guidelines of any precautionary systems in case of hazardous chemicals
• Co-ordination with Warehouse, QA, Engineering, production, packing and other cross functions
• Co-ordination with contract testing laboratory and review of analytical reports for its compliance
• In the absence of reviewer, review all the document and logbook. Also, in case of workload on reviewer, review documents & related logbook
• Adherence to laid down systems and procedures while execution of job responsibilities
• Timely reporting of any incidences /OOS/OOT, non-conformances observed
• Adherence to company s laid down code of conduct and discipline
• Reporting of any illness / contagious disease
• Providing assistance and execution of any task allocated by HOD as and when required
• Good computer skills and sound working knowledge of Microsoft Office
• Good organizational, presentation and analytical skills
• Good knowledge about Good Laboratory Practices and Good Documentation Practices