Manager, Global Quality Compliance

Sun Pharmaceutical Industries; Princeton (NJ); Vor Ort; USD 101.000 - 112.500; Vollzeit

Benefits dieser Stelle

401(k) savings plan

Medical, dental and vision coverage

Annual performance bonus

Zusammenfassung

JobRx, Inc. is seeking a skilled individual to manage batch reviews of sterile and OSD manufacturing records. The candidate should possess at least five years of experience in the pharmaceutical industry and be knowledgeable about good manufacturing practices. Responsibilities include leading recording reviews and ensuring compliance with regulations.

If you have a Bachelor's degree and excellent skills in project management and software applications, we would love to hear from you. Join us in a dynamic environment with opportunities for growth.

Qualifikationen

• Minimum of Bachelor's degree required.
• Minimum of five years experience in the pharmaceutical industry.
• Thorough understanding of GMPs and good documentation practices.

Aufgaben

• Manage overall batch review of manufacturing records.
• Lead review of sterile and OSD manufacturing records.
• Participate in mock inspections and assess compliance.

Kenntnisse

GMP understanding

Communication skills

Project management

Software applications expertise

Ausbildung

Bachelor's degree

Tools

MS Word

MS Excel

TrackWise

Jobbeschreibung

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.

Compensation and Benefits

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.