Job Summary
Manage overall batch review of sterile and OSD manufacturing/packaging records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, instrument preventive maintenance/calibration/qualification/validation as per good manufacturing practices/good documentation requirements and ALCOA++ principles).
This role will be an individual contributor with expert level experience in manufacturing investigations from FDA approved facilities that make sterile and OSD products.
Area Of Responsibility
Subject matter expert (SME) understanding of sterile manufacturing and packaging.
Leads the review of sterile and OSD manufacturing/packaging records from a Global Quality perspective.
QA SME for manufacturing (Sterile & OSD), environmental monitoring, microbiology, media-fill & packaging Investigations and related CAPAs.
Successful experience with FDA inspections
Ensure that all activities are compliant with Standard Operating Procedure, STP and GP etc.
Review of equipment qualification, process validation protocols and reports for accuracy, completeness and traceability as well as adherence to the Protocol/procedures.
Training of colleagues across multiples sites.
Work in partnership with site Quality Assurance.
Follow the EHS policy, procedures and maintain the compliance to cGMP requirements.
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 concerns and supports continuous improvements.
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 five (5) years of experience within the pharmaceutical industry
Experience working in an international, multicultural matrix organization.
The presently-anticipated base compensation pay range for this position is $101,000 to $112,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience.
In addition, this position is part of the Annual Performance Bonus Plan.
Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program.
Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.
If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.