QA Specialist - Sterile Pharmaceuticals
QA SPECIALIST - STERILE PHARMACEUTICAL
Salary - GBP40,000 - GBP45,000
SyriMed is a leading manufacturer of oral solutions. We are expanding into sterile manufacturing and now need a QA Specialist with experience in Sterile QA within Pharma.
- Accountable for Validation, Quality assurance, IPQA related activity.
- Responsible for review of documents like area qualification, HVAC qualification or other validation related documents.
- Responsible for monitoring of Process Validation activities, autoclave validation, Filling machine, PSG, WFI system validation etc.
- Ensuring timely completion and compliance to QMS/ PQS elements.
- Responsible to monitor Risk Management Activities.
- Sound in gap analysis/ trouble shooting / failure investigation of product or process.
- Good knowledge on Computer system validation as per GAMP 5 guideline & Audit trail review.
- Responsible to establish Quality Management Systems as per regulatory requirements.
- Responsible to handle internal audits, customer audits & regulatory inspections and implement necessary CAPA.
- Responsible to ensure the training to concerned personnel.
- Responsible to ensure ongoing compliance with quality requirements.
- Audit of cross functional team, supplier or vendor.
- Responsible to prepare SMF & VMP.
- Responsible to ensure internal and external requirements.
- Responsible to review and conduct Quality Dashboard meetings.
- Review of SOP, Specification, and STP & GTP as per pharmacopeia or in - house method.
- Regulatory Compliance, Training Inter and Intra coordination and hosting inspections by Regulatory Inspectors, Business Partners and Customers.
- Maintain good laboratories practices.
- Responsible for supplier qualification.
ESSENTIAL EXPERIENCE, SKILLS AND ABILITIES:
- Minimum 7+ years of experience requiredin Validation & Quality.
- Must have Sterile Facility and microbiological exposure.
- Effective communication and presentation skill. Effective technical and soft skill training skill.
- Should have good knowledge and exposure on various Regulatory Guidelines and audit USFDA, MHRA.
- Auditing and CSV training certification is preferable.