Kindeva Drug Delivery
Role Summary
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
Role Responsibilities
Responsible for reviewing documents to ensure the manufacturing and testing processes adhered to the approved batch/testing record and are compliant with approved SOPs and cGMPs.
Provides QA support for manufacturing and testing activities including: shop floor oversight, deviation and laboratory investigations, change management, SOP revisions and batch documentation review
Proactively identify and address non-conformances in manufacturing operations
Performs timely reviews and determines batch acceptability and product disposition.
Able to work in a team environment within own team and interdepartmental teams independently, with minimal guidance and under short timelines while maintaining quality work.
Collects, reports and is responsible for departmental data.
Understand the manufacturing operations and quality procedures for the area(s) to facilitate compliance to regulations.
Alert management promptly to any issues identified during batch record reviews that may adversely impact manufactured products, demonstrating accountability and a commitment to maintaining high-quality standards.
Review and edit SOPs, Forms, Logbooks, and Master Batch Records to ensure accuracy and compliance with established procedures.
Participates in internal GMP audits and supports customer and regulatory audits.
Assists in review and editing of SOPs / Master Batch Records.
Other tasks assigned by management.
Basic Qualifications
High school degree required
More than 3 years of experience in the pharmaceutical industry.
Experience in Batch Record Review/Audit/Disposition
Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
Independently consistently produces quality work.
Works in a team environment within own team and interdepartmental teams.
Must work under short timelines while maintaining quality work.
Must have effective written and oral communication skills.
Collects, researches, analyzes, and presents data information skillfully.
Certified Quality Auditor (CQA) Certification preferred.
Preferred Qualifications
Bachelor's degree in a scientific discipline is preferred.
Physical Qualifications
Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
Must have the ability to work effectively under and manage to strict production, time, and performance deadlines.
Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may occasionally include weekends and holidays.
The scheduled hours for this position are Monday through Friday 10:00 am - 6:00 pm and will eventually change to 2:00 pm - 10:30 pm.
Job Details
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
Earth City, MO
Salary: $60,000.00-$65,000.00
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Role Responsibilities
Responsible for reviewing documents to ensure the manufacturing and testing processes adhered to the approved batch/testing record and are compliant with approved SOPs and cGMPs.
Provides QA support for manufacturing and testing activities including: shop floor oversight, deviation and laboratory investigations, change management, SOP revisions and batch documentation review
Proactively identify and address non-conformances in manufacturing operations
Performs timely reviews and determines batch acceptability and product disposition.
Able to work in a team environment within own team and interdepartmental teams independently, with minimal guidance and under short timelines while maintaining quality work.
Collects, reports and is responsible for departmental data.
Understand the manufacturing operations and quality procedures for the area(s) to facilitate compliance to regulations.
Alert management promptly to any issues identified during batch record reviews that may adversely impact manufactured products, demonstrating accountability and a commitment to maintaining high-quality standards.
Review and edit SOPs, Forms, Logbooks, and Master Batch Records to ensure accuracy and compliance with established procedures.
Participates in internal GMP audits and supports customer and regulatory audits.
Assists in review and editing of SOPs / Master Batch Records.
Other tasks assigned by management.
Basic Qualifications
High school degree required
More than 3 years of experience in the pharmaceutical industry.
Experience in Batch Record Review/Audit/Disposition
Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
Independently consistently produces quality work.
Works in a team environment within own team and interdepartmental teams.
Must work under short timelines while maintaining quality work.
Must have effective written and oral communication skills.
Collects, researches, analyzes, and presents data information skillfully.
Certified Quality Auditor (CQA) Certification preferred.
Preferred Qualifications
Bachelor's degree in a scientific discipline is preferred.
Physical Qualifications
Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
Must have the ability to work effectively under and manage to strict production, time, and performance deadlines.
Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may occasionally include weekends and holidays.
The scheduled hours for this position are Monday through Friday 10:00 am - 6:00 pm and will eventually change to 2:00 pm - 10:30 pm.
Job Details
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
Earth City, MO
Salary: $60,000.00-$65,000.00
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