Quality and Regulatory Compliance Officer Pharmaceuticals - Chemical

  • Full-Time
  • Redditch
  • Competitive
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Plan and implement internal and external Auditing function to ensure continual compliance and certification of the Business; plan and implement supplier and other supply chain third party evaluation to include travel in the UK and abroad; produce audit reports and lead non-conformance resolution plans.

Supports the Quality Control function to ensure the quality of products developed, manufactured, purchased and sold by the company.

Supports the QRESH Manager with auditing work processes, investigating root cause of process deviation and ensuring process compliance by implementing corrective actions and providing guidance and training.

Supports the QRESH Manager in providing punctual and thorough Regulatory advice to the Business.

Support the QRESH Manager for Regulatory, Health, Safety and Environmental compliance of the company.

MAIN DUTIES & RESPONSIBILITIES

  • Responsible for planning and implementing audit programme by external assessors (regulatory authorities, certification bodies and customers) to ensure compliance and maintain certification to ISO 9001, MHRA, GDP, RSPO, Ecovadis, SEDEX and Safety standards; proactively support plans to improve and expand the accreditation portfolio of the business. Responsible for planning, scheduling and implementing the internal Audit programme.

  • Responsible for planning and implementing the assessment programme of suppliers and supply chain third parties, remotely or by traveling to sites as required. Produce reports and issue recommendations.

  • Support the QC function with creation and execution of QC protocols for in-process materials and release of finished products, packaging and labelling to specification.

  • Support QC services to Sales units to continually sustain company growth. Support with management of the complaints system, investigates root causes, liaises with internal and external stakeholders, implements corrective and preventive action, communicates outcomes.

  • Support production and circulation of QC KPI statistics and trend analysis and general internal compliance by continually increasing team productivity.

  • Support QRESH Manager in ensuring compliance with Health, Safety, Environmental and Regulatory standards.

KNOWLEDGE, SKILLS AND ABILITIES

  • Educated to degree level/equivalent

  • Knowledge of quality systems

  • ISO trained auditor

  • Understanding of the sensitivities associated with a commercial sales operation and of the pivotal role the QRESH function has in the Supply Chain.

  • GMP and GDP trained

  • Hands-on experience in participating in audits by external assessors (regulatory authorities, certification bodies or customers).

  • Planning and coordination skills

  • experience of Quality Control in a manufacturing environment and familiarity with a wide range of test techniques

  • Excellent computer literacy, including word processing, spreadsheet software, and database applications

 WORK PATTERN

  • Monday to Friday 

  • Business hours 9am – 5pm

  • Occasional flexible availability between the hours of 6am and 10pm

  • Excellent numerical approach to carry out data trend-analysis and ability to identify and interpret variation patterns

  • Meticulous attention to detail and ability to perform tasks with accuracy and efficiency in mind.

 

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