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Senior Quality Assurance Specialist
2 weeks ago
Quality Assurance Manager Job Description
This position is responsible for the overall quality management of a site, including managing and maintaining Quality Systems, coordinating change controls, managing deviations and market complaints.
">- Main Responsibilities:
- Compilation, review and management of product quality reviews system
- Act as site coordinator for change control and management of change control system
- Management of deviation system
- Management of market complaint investigation system
- Act as QA focal point for OOS/OOT management
- Management of training system
- Oversight on pest control system
- To perform nitrosamine assessment and review
- Management of ICH Q3D requirements
- Site coordination for implementation of Sanofi global standards and global operating procedures
- Act as focal point for subcontractors/service providers management
- Management of overall validation systems (process, cleaning, transport and computerized system)
- Management of CAPA system
Quality Management Systems
This role involves coordinating self-inspection activities, reviewing and approving GxP documents, implementing quality documents and managing document control. Additionally, it includes coordinating cGMP training activities, initiating and implementing change controls, and supporting in deviation investigations and market complaint investigations.
">- Key Activities:
- Coordinating self-inspection activities
- Reviewing and approving GxP documents
- Implementing quality documents and managing document control
- Coordinating cGMP training activities
- Initiating and implementing change controls
- Supporting in deviation investigations and market complaint investigations
- Implementation of assigned CAPAs and support in closure
- Implementation of assigned Efficiency Reviews (ERs)
- Act as PPO (Primary Process Owner) for QMI (Quality Maturity Index) as assigned
- Batch release and response to queries from QP
- Management of data integrity aspects
- Participation and support in SMS initiatives
- Support for HSE activities
- Handling of Site Master File (SMF)
- Calibration document review of Engineering/QC/PMTD
- User access management & review
- Analytical method creation
- Audit trail review
- Document archival/retrieval management
Validation and Qualifications
This role involves being the quality focal point for all validations and qualification activities, including process, cleaning, transport and computerized system qualifications. It also includes temperature/relative humidity mapping activities, study related to hold time of products, cleaned/uncleaned equipment hold time, campaign length, utilities and purified water system management, and site qualification and validation master plan management.
">- Key Activities:
- Being the quality focal point for all validations and qualification activities
- Temperature/relative humidity mapping activities
- Study related to hold time of products, cleaned/uncleaned equipment hold time, campaign length
- Utilities and purified water system management
- Site qualification and validation master plan management
In-Process Quality Assurance [IPQA]
This role involves reviewing and approving master batch records and executed batch records, reviewing and approving logbooks, line clearance in production, performing in-process checks in production, sampling of products during routine production and validation, and quality oversight on shopfloor.
">- Key Activities:
- Reviewing and approving master batch records and executed batch records
- Reviewing and approving logbooks
- Line clearance in production
- Performing in-process checks in production
- Sampling of products during routine production and validation
- Quality oversight on shopfloor
HSE
This role involves adherence to health safety and environmental aspects as required by company policies and procedures, ensuring safe working conditions, conducting daily training in +QDCI meeting addressing any unsafe condition, taking suggestions from associates to improve work conditions with great safety and zero risk, periodic review of implemented procedures and evaluation of the same, training people on safety and their job to ensure zero LTI and IWLT at workplace.
">- Key Activities:
- Adherence to health safety and environmental aspects
- Ensuring safe working conditions
- Conducting daily training in +QDCI meeting
- Taking suggestions from associates to improve work conditions
- Periodic review of implemented procedures and evaluation of the same
- Training people on safety and their job
Qualification and Experience:
Bachelor's degree in pharmacy or equivalent experience. 3-5 years of experience in quality assurance, preferably in a pharmaceutical industry.