Process Quality Assurance Supervisor

Position Summary

IPQA Supervisor is responsible for supervision of in-process quality checks in pre-weigh, compounding, batching, warehousing, and filling departments. They must have thorough understanding of product flow, manufacturing processes, equipment, pharmaceutical, GMP, and cosmetics quality principles, and knowledge of GMP/GDP practices, Health Canada, FDA, and ICH regulations and guidelines.

• Supervise daily activities of in-process quality assurance team and prioritize tasks.
• Determine and set goals for IPQA team.
• Participate in hiring new team members.
• Create and manage existing IPQA related processes within Apollo SOPs to keep them current with regulatory requirements and actual staff activities.
• Perform periodic review of SOPs as per Apollo SOP.
• Participate in internal company audits; analyze outcome issues and propose and implement remediation actions.
• Develop, implement, and supervise training systems for operation and IPQA personnel with emphasis on quality.
• Supervise line clearance, AQL, and in-process checks and all associated documentation throughout the manufacturing lifecycle.
• Be an essential part of deviation, CAPA, and change control activities.
• Lead continuous improvement and perform change control issuance as necessary.
• Assess performance of group members as required.
• Stay aware of compendia updates and new trends in pharmaceutical/cosmetics quality assurance.
• Schedule and conduct IPQA team meetings.
• Maintain clean and safe work environment and ensure safety of direct reports.
• Perform other departmental duties as required.

Education/

Experience:

university or college degree in science/engineering with 3-5 years of QA experience in pharmaceutical, GMP or cosmetic environment.

Interpersonal Skills/Contacts:
Strong leadership skills and excellent interpersonal skills.

Problem Solving/Judgment:
Ability to analyze and make decisions.

Mental Effort:
Moderate levels of concentration, attentiveness, thinking, watching, listening, verifying, checking numbers, creating or designing.

Physical Effort:
Standing and walking for long periods of time; occasional exposure to chemicals, fumes, smoke; exposure to machinery; may require travel to CMO/vendor sites (5%).

Material Resources:
High level of consequence and costs associated with errors.

Information Resources:
Moderate responsibility for information and services; access to confidential, sensitive or proprietary information.

People / Policies / Practices:
Responsibility for people, policies, performance, scheduling, training, coaching, well-being.

Financial Resources:
Limited responsibility for financial data.

Environment:
Works in a manufacturing environment with exposure to dirt, dust, grease, oil, noise or temperature extremes.

Hazards:
Average to moderate exposure to chemicals, fumes or smoke; potential injury or illness; may require travel.

Accommodation:
Apollo is committed to providing accommodations for people with disabilities in all parts of the hiring process. Apollo will work with applicants to meet accommodation needs that are made known to us in advance.