Quality & Compliance Officer
Job type
Shift and schedule
Location
Billingshurst, West Sussex
Benefits
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20 days holiday (excluding Bank Holidays), increasing to 25 after five years service
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Free on-site parking
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£26,000 to £34,000 depending on experience
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Employee Assistance Programme
Hydrachem Ltd are looking for a quality officer to join our team here in West Sussex. The selected candidate will be required to work within a small team to execute the management team’s plan to maintain regulatory approval and improve the current infrastructure/ procedures in line with GMP, ISO & BRC guidelines.
The ideal candidate will take a hands-on approach in their work, be experienced working with growing teams, and have experience working in a GMP environment.
Start date is negotiable and the role will be permanent.
Job Role: To support the Quality and Compliance Manager, Supervisor and Technicians, and Production and Technical Managers, in the generation and revision of Quality documentation, as well as the review and compilation of batch-related documentation, generated both internally and externally.
Principal Responsibilities:
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Ongoing management and improvement of the Hydrachem Quality Management System, including archiving to regulatory requirements.
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Review of the batch manufacturing/testing/packaging documentation and finished goods for compliance with approved procedures and specifications for product release.
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Performing effective OOS, complaint and Deviation investigations to identify root causes and appropriate CAPAs.
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Writing and review of OOS and complaint Investigations, Deviation Reports and CAPAs.
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Review of master processing documents against licence details and Technical Agreements prior to use.
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Participation in the internal audit programme
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Auditor facing participation in regulatory audits.
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Requesting, executing and reviewing Product Quality Review reports.
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Writing and amendment of Standard Operating Procedures.
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Review, processing of, and responses to, customer complaints.
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Creation, review and approval of validation protocols and reports.
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Supporting project based activities.
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Providing training as requested, and in line with current internal policies regarding training.
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Providing support in New Product Introduction.
Knowledge, Skills and Experience Required:
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Education to degree Level, or equivalent would be advantageous, but not mandatory. A degree in Chemistry, Pharmacy, Biochemistry, Microbiology or Biology would be desirable.
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Effective time management skills with a flexible approach and the ability to adapt quickly to changing priorities.
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Self-motivated and organised with ability to work using own initiative and as a team.
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Good attention to detail and ability to follow defined procedures and regulatory guidelines.
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Excellent interpersonal and communication skills.
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Good IT skills (Excel, PowerPoint, Outlook, Word).
Experience required:
- Quality Assurance or Quality Control: 2+ years
Work Location: