Quality Manager / Responsible Person
Pharmalliance ConsultingPosition: Quality
Manager & Responsible Person (RP)
Duration: 6 months, contract, potential to extend.
Location: Remote with 2-3
days of office attendance in City West.
Position
Overview:
Pharmalliance
Consulting Ltd is seeking a detail-oriented and compliance-driven Quality
Manager / Responsible Person (RP) to support a cosmetic manufacturing client.
In the role
you will ensure the company’s cosmetic products meet all regulatory and quality
requirements. The successful candidate will oversee product compliance with
Regulation (EC) No. 1223 / 2009, HPRA requirements, and ISO 22716 Cosmetics
GMP, including maintaining Product Information Files (PIFs), verifying Cosmetic
Product Safety Reports (CPSRs), and managing product notifications in the
Cosmetic Product Notification Portal (CPNP).
The ideal
candidate will have strong regulatory knowledge, excellent organisational
skills, and proven experience in quality management, labelling / claims
compliance, and coordination with Contract Manufacturing Organisations (CMOs).
Key
Responsibilities:
1. Legal & Regulatory Compliance
· Act as the Responsible Person (RP) as defined in Regulation (EC) No.
1223 / 2009.
· Ensure each cosmetic product has a complete Product Information File
(PIF) accessible at the company’s address.
· Verify that each product has a Cosmetic Product Safety Report (CPSR)
signed by a qualified safety assessor.
· Submit and maintain product notifications in the Cosmetic Product
Notification Portal (CPNP) prior to placing products on the market.
· Ensure compliance of product labelling, claims, and language
requirements.
· Ensure compliance with animal testing bans under Articles 17 and 19 of
the Regulation.
2. Quality Management System (QMS)
· Oversee the company QMS in line with ISO 22716 Cosmetics GMP.
· Maintain SOPs, training, and controlled quality documentation.
· Manage supplier and CMO approval, qualification, and Quality Agreements.
· Monitor deviations, CAPAs, and change controls.
· Review and approve product batch release documentation.
3. Post-Market Responsibilities
· Act as the primary contact for HRPA and other competent authorities.
· Coordinate complaint handling, adverse event monitoring, and recalls.
· Maintain traceability and distribution records to enable rapid product
withdrawal if necessary.
· Ensure periodic product safety reviews and continuous compliance
monitoring.
4. Authority & Leadership
· Report directly to the Managing Director.
· Provide resources and guidance for regulatory and quality functions
across the company.
· Maintain full authority to stop distribution or escalate processes where
non-compliance or product-risk is identified.
Requirements
Qualification
& Skills
· Degree in science-based, e.g. chemistry, biology, toxicology, pharmacy, cosmetic
science or a related life sciences discipline (required by EC 1223 / 2009 for
RP duties).
· Minimum 3 – 5 years’ experience in quality, regulatory affairs, or
compliance within cosmetics, personal care, or related industries.
· In-depth knowledge of Regulation (EC) No. 1223 / 2009, ISO 22716, and
HPRA expectations.
· Strong experience with PIFs, CPSRs, CPNP notifications, labeling, and
claims compliance.
· Familiarity with complaint handling, recalls, and post-market
surveillance.
· Excellent organisational, communication, and decision-making skills.
Benefits
Working
Hours & Compensation
· Full-time position with occasional on-site visits to office / CMOs /
vendors and attendance during HRPA inspections as required.
· Flexible working hours with availability during EU business hours.
· Competitive salary commensurate with experience.