QA Specialist - Sterile Pharmaceuticals

Recruiter
B&S Group
Location
Ruislip
Salary
40000.00 - 45000.00 GBP Annual
Posted
07 Apr 2021
Closes
12 Apr 2021
Sectors
IT
Contract Type
Permanent
Hours
Full Time

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.

PRIMARY RESPONSIBILITIES:

  • 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.

SECONDARY RESPONSIBILITIES:

  • 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.

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