Role : Manager - Lab Automation Specialist
Company Name : MSD
Company Website: www.msd.com
Experience : 2 - 4 Years
Mode of Interview: Virtual
Salary : As Per Industry Standared
Education : Bachelor’s Degree or higher in Computer Science, BS Biology, Microbiology, Pharmacy, Chemistry, Engineering or demonstration of the applicable experience
Location: Pune, Maharashtra
Hiring Process: Technical Interview, HR Interview
Job Description:
- Experience with VBA programming and developing excel formulas.
- Knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products.
- Processes change controls following applicable procedures and documents changes in an electronic repository.
- The projects assigned are technical in nature and require a working knowledge of analytical testing methods and GMP Compliance.
- Ensure on time implementation of workbook changes through collaboration with business areas in support of requirements definition, functional design, and configuration.
- Provides second person review support for team members change control documents to source documents to ensure accuracy, compliance, integrity, and completeness.
- Experience with authoring test protocols to validate the change based on requirements and design, and execution of test scripts. Familiarity with electronic testing tools (eVal or other) is preferred.
- Experience with use of LIMS (Labware LIMS v6 or higher, or other) including but not limited to knowledge of developing analyses, product specifications, environmental monitoring, lot manager, project manager, stability manager, storage location manager, standard and Reagent, and instrument manager.
- A minimum of 2 years of experience in VBA programming for development/validation of Microsoft Excel workbooks for GMP use in regulated environment.
- Familiarity with LIMS to support Release testing, Stability, and Environmental Monitoring.
- Candidate must have knowledge of regulatory expectations for the manufacture and testing of vaccines, biological products, or sterile pharmaceutical products.
- Experience with System Development Life Cycle (SDLC) and Validation requirements ensuring compliance with regulatory requirements.
- Ability to write test scripts and support execution of validation protocols adhering to SDLC.
- Incumbent must complete technical assignments independently once specific objectives have been defined.
- Possesses a technical aptitude for computerized systems, analytics, and method evaluations.
- Flexible working hours (up to ~25%/week) are required to support collaboration with project teams in US East coast, especially during initial training period.
About Company :
Our customers have always known that they can depend on MSD Animal Health for more than just medicines. They count on MSD Animal Health for information, technologies and veterinary services that truly advance animal healthcare. It is our heritage and our mission.Today, our science supports the precious bond between people and their pets. It also helps protect international public health, ensure food safety and increase protein supplies.
We operate in more than 150 countries.
We’ve achieved our reach through an absolute commitment to regional understanding. It helps us react quickly to changing disease landscapes around the world. We help protect public health and effectively address local concerns.
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