Job Description
Compliance Specialist
Petersfield
Days 8.15am - 4.30pm Mon day - Friday
Description
My client is currently recruiting for a Compliance Specialist within the Quality Department to join an experienced and committed team. A global manufacture of makeup, fragrance and skin care.
The successful candidate will be responsible for implementing policies, procedures and standards at a site to ensure compliance with regulatory and corporate requirements. This includes management of GMP document control systems, development of annual product review reports, administration of the compliant program, supporting site audits and development & delivery of GMP trainings.
Requirements
* Experience in a regulated industry is required, cosmetic or pharmaceutical experience a plus.
* Experience with improving Quality Systems required
* Experience with authorizing and maintaining procedures and work instructions is required
* Knowledge of compliance, related to all applicable Quality Systems Standards national and international, is required
* Creative individual with excellent trouble shooting skills
* Strong oral and written communication skills with ability to appropriately communicate information to cross functional stakeholders
* Ability to work in a team setting and independently under minimal supervision
* Ability to work in fast paced environment supporting the quality assurance/quality control departments
* Proficiency in Microsoft Office Suite, Electronic QMS, e-training systems and SAP systems is preferred
Key Roles & Responsibilities
* Implement and ensure adherence to policies, procedures and standards site wide
* Maintain knowledge and understanding of applicable GMP regulations, regulatory agency guidelines, industry association guidelines, Corporate requirements and best practices
* Conduct Internal audits ensuring actions are documented, addressed and tracked appropriately
*
* GMP Audits
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* Hygiene audits
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* QMS internal audits
* 3rd Party audit management / follow up and corrective action plans
* Veeva Quality One (EQMS) Quality role - reviews / approvals for CAPA, Deviations / INC / INV & Change controls
* Veeva Quality One (EQMS) site representation with Global team / SME
* OpenText (Document management system) review / approval / system Admin
* General QMS oversight driving continuous improvement across all departments against defined KPIs
* Identify other areas for CI utilising audit results / trends and observations
* Quality risk assessment programme implementation
* Validation protocols Quality role - review / approval
* Global Compliance team liaison / site representation
* Annual Product Reviews
Characteristics of a successful candidate:
Experience in a regulated industry is required, cosmetic and pharmaceutical experience a plus
Experience with improving Quality Systems and process design is required
Experience with authorizing and maintaining procedures and work instructions is required
Knowledge of compliance, related to all applicable Quality Systems Standards national and international, is required
Ability to build and deliver training modules
Creative individual with excellent trouble shooting skills
Strong oral and written communication skills with ability to appropriately communicate information to cross functional stakeholders
Ability to work in a team setting and independently under minimal supervision
Ability to work in fast paced environment supporting the quality assurance/quality control departments
Proficiency in Microsoft Office Suite, Electronic QMS, e-training systems and SAP systems is preferred