Senior Associate, Quality Compliance

Job Summary

Responsible for batch certification review of site QA activities related to manufacturing batch records, packaging records and all related supporting documentation (i.e. documentation review, SOP compliance, equipment/ instrument preventive maintenance/ calibration/ qualification/ validation as per good manufacturing practices/ good documentation requirements and ALCOA++ principles).Provides supporting role during regulatory, corporate and internal audits.

Area Of Responsibility

• Supports Batch certification activities related to USA/Canada commercial distribution in a timely manner. Ensures activities are aligned with schedule and deliverables.
• Subject matter expert level understanding of sterile manufacturing and packaging.
• Conducts Investigation reviews of Site Incidents/Deviations (planned, unplanned deviations, FARs). Ensures Corrective and Preventive actions are adequate.
• Ensure compliance to regulatory requirements on product, process, equipment and release procedures.
• Provides support for all regulatory audits, internal/external inspections, and other audits. Responsible for follow ups on all related Operational findings from FDA, other regulatory bodies, internal audits, etc.
• Participates and conducts mock inspections to prepare the facility for audits and assesses gaps in the system; review documents for compliance to current regulations and cGMPs.
• Identifies compliance issues and supports the implementation changes for constant improvements. 
• Supports adherence to SOPs and policies and assists in ensuring that procedures reflect current practice.
• Performs additional assignments as needed.

Work Conditions:

Corporate Office Environment

Manufacturing / Production Environment

Laboratories

Warehouse Environment

Field Familiarity Environment

Physical Requirements:

• Must be capable of bending and lifting, moving and/or carrying up to approximately 10 pounds.

• Ability to navigate office, lab and/or plant floor working environments, stands, ambulates, and reaches.
• Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Travel Estimate

Up to  30  %

Education and Job Qualification

• Minimum of Bachelor’s degree
• Role supporting seminars and courses are an asset.
• Thorough understanding of GMPs, specifically those relating to good documentation practices
• Ability to work effectively in an international multicultural matrix organization
• Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise, LMS (Learning Management System) etc.
• Knowledge of project management principles, practices, techniques and tools
• Strong communication, interpersonal and organizational skills
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Experience

• Minimum of seven (7) years of experience within the pharmaceutical industry
• Experience working in an international multicultural matrix organization.