Dr Reddy’s Chemistry & Pharma Job – Team Member Validation
Chemistry jobs at Dr Reddy’s. Applications are invited for the Team Member temporary position. Interested and Eligible candidates with chemistry filed may apply for this position at Dr Reddy’s. Check out all the details exclusively on Rasayanika.com
Dr. Reddy’s Laboratories Ltd. is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastrointestinal, cardiovascular, diabetology, oncology, pain management and anti-infective.
Job Title: Team Member Validation
Location: Hyderabad
No.of posts: 02
Eligibility: B.tech chemistry, MSc Chemistry, M Pharma
Experience: 4-8 years of experience in Validation, Manufacturing, Process engineering working on Pharmaceutical /Bio-pharmaceutical industry., At least 2 year of conducting validation activities in a GMP licensed facility that includes aseptic and/or sterile manufacturing.
Key Responsibilities:
- Develop/Prepare validation documents such as Validation Master Plan, Project specific validation plan, Qualification protocols & report and other validation documentation.
- Responsible for Execution of Facility/Utility/Equipment Qualification & Cleaning Validations.
- Preparation of DQ, FAT, SAT, MC, CTP, IQ, OQ, PQ and VQ Protocols in line with Standard Procedure, cGMP, company standards, policies and other regulatory requirements (GDP, GEP).
- Initiation & tracking of quality management system related activities pertaining to Equipment, Utility & Systems Qualification. (Deviations, Change notifications, CAPA).
- Understanding of Regulatory requirements as per 21 CFR Part 11, EUGMP Annexure 11, PICs and other equivalent regulations.
- Plan and execution of Manufacturing Equipment / Quality Control Equipments / Utility qualifications and re-qualifications as per Validation Mater Plan.
- Co-ordination with Production, Quality Assurance, Engineering, Projects, & Vendors for collection of data and reports.
- Preparation, review and revision SOPs and other documents related to validation.
Qualification of new, shifted equipment /system for intended purpose on time as per approved project timelines. - Sound knowledge in process equipment, analytical equipment, utilities and HVAC related to bio-similar manufacturing.
- Strong exposure in preparing risk assessment and GAMP assessment, Knowledge in GMP and regulatory requirements for validation within the pharmaceutical/Biopharmaceutical industry (ICH, PDA, ISPE, ASME, ISO, EU, USFDA).
- Compilation of URS, DQ, PO & Relevant Certificate/ Traceability documents.
- Review of URS, Deviations, Risk Assessments, Project Specific Validation Plans, Concept Notes, Miscellaneous documents, Vendor Qualification documents, Drawings, Test certificates etc.
- Completing allotted Qualification/Validation activities as per the defined schedule of Renovation or Expansion Projects.
- Coordination with external service providers related to qualification activities.
- Providing execution support for intra function activities like Cleaning Validation, Process validation and documentation as required.
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