Job Description
Exposure on Regulatory requirements for automated systems and knowledge of GMP, GAMP, EU Annex 11 and 21 CFR Part 11 of USFDA (Electronic Records and Electronic Signatures).
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Exposure on Regulatory requirements for automated systems and knowledge of GMP, GAMP, EU Annex 11 and 21 CFR Part 11 of USFDA (Electronic Records and Electronic Signatures).
Implementation of life cycle methodology (concept, planning, design, testing, maintenance, retirement) and assess systems based on criticality and complexity of systems.
Expertise in Computer System Validation of Software Applications, Data Acquisition systems, Process Automation Systems, Packing Systems, BMS and particle monitoring systems.
Perform gap assessments of existing validated systems to determine potential risk/ compliance concerns. Prepare summary report of gap assessments and provide recommendations.
Prepare action plans to remediation plans to close gaps and implement improvements.
Prepare and guide team & cross functional teams in preparation & review of CSV Qualification Plan, protocols and other deliverables & harmonizing procedures to reduce duplication efforts.
Experience in Functional & Security testing as per 21 CFR Part 11 and Annex11 guidelines, anticipate failures & resolve issues with coordination of system developers.
Guide cross functional teams & coordinate with all stake holders to maintain compliance (including modifications) of validated systems as per Regulatory, Organizational Policies & procedures.
Conducting Vendors (service provider) Audits and provide guidance in Qualification and control of Service providers and revision of existing Policies/SOPs as per regulatory changes.
Expertise in handling of Quality Management Systems like Change Control, Deviation Control and Corrective Action and Preventive Action and review of QRM and implementation of CAPA.
Preparation of audit compliance response to regulatory authorities & customers. Implement compliance action plans, continuously monitor to maintain and improve compliance status.
Knowledge in implementation of ASTM E2500, SDLC and cGMP (21 CFR Part 210 & 211).
| Desired Profile | Please refer to the Job description above |
| Experience | 3 - 6 Years |
| Industry Type | Pharma / Biotech / Clinical Research |
| Role | Service/Maintenance Supervisor |
| Functional Area | Production, Manufacturing, Maintenance |
| Education | UG - Any Graduate - Any Specialization PG - Any Postgraduate - Any Specialization DOCTORATE - Any Doctorate - Any Specialization, Doctorate Not Required |
| Location | Hyderabad / Secunderabad, Visakhapatnam/Vizag |
| Keywords | Computer System Validation |
| Contact | Srinivas Mekala Dr Reddys Laboratories Ltd Hyderabad HYDERABAD,Andhra Pradesh,India 500034 |
| srinivasmekala@drreddys.com | |
| Website | http://www.drreddys.com |
If above Post not related to you please forward to your friends..because its CAREER Matter. Refer www.pharmanaukri.info
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