Syngene Quality Assurance Executive Job – Apply Online
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Job Title: Senior Executive
Job Location: Bangalore
Department: Quality Assurance (Chemical Development)
Educational Qualification: M.Sc., M. Pharm with Total Quality Management (TQM) or equivalent.
The candidate must be aware of Quality management system, process & cleaning validation, exposure of current quality guidelines, good knowledge of DI perspective, vendor & warehouse management, IPQA skills followed Equipment qualification, Calibration related to Engineering & Maintenance supports. Good investigation writing skills & good English speaking & writing skills. Knowledge of CSV, EHSS is also preferred.
Experience: 4-6 years
Intellectual adaptability, personal integrity, interested in self-learning & development, result-oriented, Quality conscious, customer-centric, result-focused, to build good relationships with inter-department personnel.
- Should be aware of QMS system to small molecule API facilities and participates in Initiation, review and approval/ rejection of Change controls, deviations, & Risk assessments OOS investigation, Client’s or regulatory audit co-ordination, Audit CAPA initiation and follow-up and closure and Preparation, Review and approval of Quality agreement, APQR.
- To comply with all the regulatory audits like USFDA, PMDA, WHO, EUGMP, TGA and other regulatory agencies. All the time ready for compliance with regulatory and Client’s expectations.
- Responsible for Preparation, Review and approval VMP, Validation protocols and report (Process, Analytical and cleaning) and monitoring commercial validation batches and training for the execution of the validation. Taking independent responsibility of Process and Cleaning validation of specific Clients requirements in line with FDA, APIC & other regulatory guidelines on process, analytical & cleaning validation.
- To attend regular tele conic and support Client’s expectations, provide on-time support to meet the specific timelines. Must be having very good skill of assessing, writing and finalization of investigations on any such process, cleaning and analytical validation requirements in line with regulatory expectations.
- Responsible for preparation & review of master/ Executed BMRs, PDRs, line clearance, dispatches followed by batch release. Implementation of the Quality management system in the Small molecule API/ intermediate facility.
- Knowledge of new facility commissioning and Qualification, computerized system validation, routine qualification and validation, activity. Support to the calibration and preventive maintenance activity. Well-versed with preventive & breakdown maintenance, calibration, HVAC systems, utilities followed by any activities pertaining to projects and Engineering and maintenance. Expertise in the specific guidelines like EU Annex 11, 21 CFR Part 11, GAMP 5 and expert in conducting the gap analysis of computerized systems.
- Aware of the Quality System in the purchase and warehouse, participating in warehouse activities including receipt verification, line clearance, investigations, review and approval of the procedure for the small molecule drug substance.
- Vendor & Warehouse management, Cleaning & Process validation expertise, awareness of Quality management system as per current guidelines.
- Follow environment, health, and safety (EHS) requirements always in the workplace ensuring individual and lab/plant safety.
- Attend training on environment, health, and safety (EHS) measures imparted company.
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