Supervisor-quality

2 days ago

Shirwal, India ACG Full time

Group Company- ACG Pharmapack Pvt. Ltd.- Primary Responsibilities- Strategic and planning- Ensure compliance of CTQ requirements in order to eliminate repeat complaints from customers.

Core Functional
- Core- Conduct testing of material as per Quality Plan and assign and inform Quality Status to Production.
- Analyse of product/process non-conformity along with concerned production team to find out root cause of the issue.
- Adhere compliance to all laid down SoP’s and Work Instructions as per cGMP, ISO, and other systems in QA lab.
- Analysis of internal and external customer quality issues.
- Maintain all equipment of QA lab are in working conditions.

Internal Processes- Prepare reagents for testing wherever necessary and keep checking the strength of reagents/material at regular intervals.
- Sampling of semi-finished products & slit reels as per sampling plans, conduct analysis as per quality plans, work instructions and share results with concerned department.
- Communicate deviations as per laid down systems.
- Ensures all the reagents/counter samples (Retention) are label with relevant details.
- Maintain records and samples in a systematic way for early retrieval and traceability.
- Prepare Monthly Information System (MIS) report for the deviations observed along with the action plan which includes the CAPA effectiveness submitted against the internal/external rejections/complaints during execution of respective customer orders.
- Key Result Areas- Eliminate customer complaint in shift for any quality/technical reason.
- Eliminate deviations in shift (SAP entry, roll stamping, red card clearance, documentation, GMP practices on shop floor).
- Monitor and devise action plan along with production team to achieve reduction in COPQ as per Business requirement.
- Ensure order processing of customers as per Sales Order and Critical to Quality (CTQ).
- Prepare Monthly Information System (MIS) report for the deviations observed along with the action plan which includes the CAPA effectiveness submitted against the internal rejection.
- Key Interfaces- Planning
- Production
- Safety
- Human Resources
- Purchase
- Development & Technology
- Sales
- Business Development
- Suppliers & Vendors
- Service providers.
- Educational and Experience Requirements- BSc. Chemistry/CIPET with 2-6 years of work experience.- Technical Competencies & Personas- Quality Requirement (Manufacturing)- Working experience in writing Pharmaceutical Validation/Qualification documents- Knowledge of cGMP and ISO- Regulatory & Risk Management- Persona-Entrepreneur- Persona-Innovator- Persona-Partner

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