Quality Assurance Associate

Job Title: Quality Assurance Associate - Global Pharmaceutical Company

Location: Macclesfield

Contract: 12 months

SRG are working with a Global Pharmaceutical company to help them find a Quality Assurance Associate to join their busy team.

Responsibilities:

• You will be aligned to either the Formulation / Packing or Quality Control area where you will be required to reinforce the quality principles. You will also provide independent assurance of the maintenance of the appropriate quality standards within this area, whilst supporting timely and effective resolution of all quality issues to maintain product flow across the factory.
• You'll be responsible for making product and material release decisions, operating within global standard pack ahead of clearance (PAOC) and ship ahead of clearance (SAOC) guidelines.
• Provide leadership and support for internal and external inspection preparations as well as significant audits to aid in developing improvement plans, you will monitor any actions to ensure ongoing compliance.
• You will provide expert advice to the area on Good Manufacturing Practice/Good Development Practice/Good Distribution Practice / Good Laboratory Practice within the site, with reference to Good Manufacturing Practice guidelines and regulations.
• Support the License to Operate processes within the aligned department, advising on deviations using professional discernment to make batch disposition recommendations to approve or reject a product.
• Assist in reviewing investigations to ensure root cause is established and appropriate countermeasures are in place and will support customer complaint investigations and approve investigation reports.

Requirements:

• Degree or equivalent professional qualification in a science / technical field such as Pharmacy, Chemistry or Biology
• Prior experience in Good Manufacturing / Good Distribution / Good Laboratory practice and/or compliance management
• A level of technical process understanding in manufacturing or packing or warehouse/distribution or Quality Control
• Knowledge of and application of quality systems, including change control, deviation management and New Product Introductions
• Awareness / knowledge of regulatory interactions and compliance procedures and ability to apply this in an operations environment
• High level of customer focus and strong ability to reinforce and maintain quality standards
• Knowledge of other areas of the Supply Chain, including groups such as Regulatory, Global Quality, Manufacturing, Supply and Capability etc.

To apply click the link or send your CV to thomas.ramsey@srgtalent.com