QA Specialist

Sterling Pharma Solutions Limited; Cramlington; On-site; GBP 35,000 - 50,000; Full time

Job summary

A pharmaceutical company in Cramlington is seeking a QA Specialist to handle batch sentencing and ensure quality assurance activities meet GMP standards. Key responsibilities include review of production processes, compliance audits, and managing QA systems. A degree in a scientific field and experience in the pharmaceutical industry are required. Excellent communication skills are essential for this role.

Qualifications

• Experience within Active Pharmaceutical Ingredient or Pharmaceutical Industries, focusing on quality assurance.
• Comprehensive knowledge of all GMP requirements and guidelines applicable to API manufacture.
• Excellent skills in communication and the writing of SOPs and reports.

Responsibilities

• Perform batch sentencing activities on specified products and quality assurance activities.
• Coordinate validation activities and handle complaints and audit observations.
• Ensure compliance with cGMP through audits and corrective action management.

Skills

Communication skills

Knowledge of GMP requirements

Auditing experience

Education

Degree in scientific discipline

Job description

Overview

As the QA Specialist you will report directly to the Senior QA Specialist and be based at our site in Cramlington, Northumberland. The main purpose of your role will be to perform batch sentencing activities on a named set of products and all quality assurance activities (reviews/approvals/audits etc) relating to those products and specific plant/business areas. You will maintain quality systems covering specific areas of expertise, working in accordance with GMP and regulatory standards.

Responsibilities

• As a SAP user the job holder will be required to carry out assigned SAP transactions in an accurate and timely manner.
• Sentence all controlled intermediates and finished goods in an agreed timeframe, in accordance with written procedures. These cover production and analytical review, deviation and change assessment.
• Responsible for all QA approvals of PRSs, changes (process, analytical and engineering procedures) which relate to specific products to ensure they are carried out in accordance with relevant product registrations.
• Perform QA assessment of all 'Decision Paths', non-conformances and deviations (including out of calibration).
• Review all cGMP cleanouts and ensure manufacture is not commenced prior to completion of a satisfactory cleanout.
• Ensure that specific product set and specific plant/business areas are cGMP compliant through audit, review and monitoring. Identify relevant corrective actions and ensure they are closed out through QATs.
• Maintain QA systems covering change control.
• Approval of master PRSs and procedures.
• Handle complaints, audit observations and customer notifications and coordinate annual reviews.
• Responsible for coordinating validation activities.
• Complying with all environmental, health and safety requirements.

Qualifications

• Degree or equivalent in a scientific discipline.
• Experience within Active Pharmaceutical Ingredient or Pharmaceutical Industries, in quality assurance.
• Comprehensive knowledge of all GMP requirements/guidelines applicable to API manufacture.
• API quality assurance, laboratory practices and production.
• Auditing experience internal/external.
• Excellent skills in communication and the writing of SOPs and reports.