Siddiq Dudekula
experience in Validation with Strong Background in Computer system and Technical Writing with performing testing in pharmaceuticals industries including Specialization in 21 CFR Part 11 Compliance and GAMP 5, Gxp.
- Role
- Technical Lead at HCLTech
- Location
- Hyderabad, IN
- LinkedIn followers
- 500 followers
About Siddiq Dudekula
Responsible for performing GXP Assessment and GAMP categorisation Experience to computerised validation (CSV) USFDA 21 CFR part 11 EU Annex 11 and performing the ER/ES applicability Participated in the execution and monitoring of PLC and software validation of different manufacturing equipment Preparation and review of VMP and validation-related sops Expertise in reviewing and approving key deliverables Supplier assessment, Validation plan, User requirement specifications (URS), Functional requirement specifications, Design specifications, and Configuration specifications in compliance and conformance against validation guidelines. Expertise in reviewing and approving qualification/testing documentation (IQ, OQ & PQ). Preparation and review of validation deliverables (software and hardware and application procedure.(URS, validation plan, IQ,OQ,PQ scripts, Traceability Matrix, test summary report and validation summary report Expertise in verification and evaluation of security management electronic records and Electronic signatures deliverables as per 21 CFR Part 11 regulatory requirements Experience in Incident, Defect, Deviation, CAPA, Change Control, and Risk Management & mitigation plan as per Quality Management System. Proficient in the handling of various quality applications such as TCS iON Ample logic software, Track wise and SAP(Production plan),Jira and Q test
Experience
Technical Lead
Feb 2023 — Present · Bengaluru, IN
Education
Acharya Nagarjuna University
B pharm, Science
2007 — 2011
Sri Chaitanya College of Education
B pharm, Science
2007 — 2011
Jawaharlal Nehru Technological University
M pharm, Seience
2012 — 2014
Loyola public school
Bachelor of Pharmacy - BPharm, SSC
1995 — 2005
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