ACG Capsules QC Microbiology Job Opening – Apply Online
PGT- Quality Control-Lab Microbiologist, ACG Capsules (Quality) 1 1
Company: ACG
Location: Dahanu, India
Primary Responsibilities
- Plan for sampling & testing of raw materials, finished products, in-process samples, swabs, air and water, stability samples as per the given QC plans and customer specifications for microbiological testing and monitoring.
- Sampling and Environmental monitoring
- Analysis and reporting (including SAP entry and COA)
- Trending, Investigation and CAPA for microbiological failures
- Surveillance for microbiology compliance
- Calibration and validation (testing support, laboratory equipment qualification, method validation, disinfectant validation)
- GLP and documentation, laboratory facility maintenance
- Release of raw material (in absence of QC Head)
- Preparation of Microbial SOPs and STPs
- Participate in various quality improvement programs and organizational initiatives
- Isolation and identification of isolates and maintenance of standard culture
Key Result Areas
- Perform complete Microbiological testing
- Lay down systems and practices for ensuring FTR, microbiological quality of products
- In order to ensure production and delivery of microbial compliant capsules
Key Interfaces
Internal Interfaces:
QA, Production, PFD, Store, IQC
External Interfaces:
All Vendors which are included in our day to day activity.
Educational and Experience Requirements
- Timely completion and reporting of all Microbiological testing to enhance smooth production activity
- No external failures for microbiology
- No non-compliance in internal and external audits
- Improvement in microbiology trends
Technical Competencies & Personas
- Has the candidate displayed any of the Values (Caring/Collaborative/Progressive) during the discussions?
- Basic knowledge of Pharmacopoeia requirements for microbiological testing
- Good in Microsoft office (Excel, PowerPoint, Word)
- Knowledge of Microbiological Aseptic testing techniques
- In-depth knowledge on Capsules, product quality parameters, and Lab testing
Quality & Regulatory Requirements
– Quality Requirement (Manufacturing)
Personas:
- Persona-Builder
- Persona-Entrepreneur
- Persona-Innovator
- Persona-Integrator
- Persona-Nurturer
- Persona-Partner
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