Quality Assurance headLegitcapture Cosmetic Products Trading

BASIC FUNCTION
The QA, QC and Regulatory Head will lead and manage the strategic and operational performance of the Quality Assurance and Regulatory Department, achieving business strategy, Key Performance Indicators (KPIs), and objectives while ensuring regulatory compliance and commercial success. The role is responsible for the efficient, day-to-day operations of the department.
DUTIES AND RESPONSIBILITIES
Develop and implement the department's strategy, aligning it with business requirements and customer deliverables.
Implement and monitor all Quality Assurance systems for compliance, ensuring adherence to GMP for products.
Maintain an awareness of new and proposed legislation impacting the business and communicating any changes to the Senior Management Team.
Coordinate inspections and internal audits.
Serve as the main point of contact on all Quality Assurance and Regulatory matters internally and externally.
Ensure FDA regulatory compliance and maintain authorizations, including submission of variations.
Oversee the development and implementation of departmental Standard Operating Procedures (SOPs).
Establish and communicate an audit program to the Operations team.
Manage all validation activities, including the validation strategy and approval of protocols and reports.
Review the batch document and ensure that the required information's are available.
Review that all the required information filled and meets acceptance criteria.
Review that calculations are done correctly.
Ensure signatures are present of concern personnel/operator wherever applicable.
Review all steps are followed as per recommended procedure.
Ensure all necessary samples are collected and mentioned properly.
Review the correctness of reconciliation at each step.
Put the signature of "released by QA" on batch document.
Issue batch release certificate and attach with batch document.
Issue a copy of batch release certificate to warehouse and affix the release label on shippers/pellets.
Prepare, review, and approve Technical and Quality Agreements.
Lead investigations of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action.
Lead customer and regulatory audits/inspections, as required.
Manage, motivate, coach, and mentor direct reports to increase management capabilities.
Prepare and manage the Quality department's budget.
Comply with company Health and Safety Policies and SOPs.
Undertake any other duties as requested by the Line Manager.
REQUIREMENTS / QUALIFICATIONS
Essential:
A Graduate of bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field.
Possesses a valid Professional Regulation Commission (PRC) License for Pharmacist/Chemist or any related field.
Accumulated 8 years of relevant experience in cosmetics/drugs, specifically in manufacturing, as a pharmacists or Chemist.
Demonstrable track record and skills/experience gained within a similar position, at a similar level.
Strong leadership/team management skills and experience.
Highly customer-focused and commercially astute.
Excellent project management skills.
Strong analytical and problem-solving ability.
Excellent attention to detail.
Proficient IT skills e.g. Microsoft Office (Word, Excel and Outlook).
Desirable:
Understanding of the pharmaceutical market, including the unlicensed medicines sector.
Experience with products and processes used in the manufacture of unlicensed or licensed medicines.
Summary of role requirements:
Looking for candidates available to work on weekdays and Saturdays
2-3 years of relevant work experience required for this role
Working rights required for this role