QA Validation Manager

Job Description

Job Description

Join a Leader in the OTC Industry!

LNK International - a leading OTC pharmaceutical manufacturer located in Hauppauge, Long Island, NY, seeks an experienced Quality Assurance Validation Manager to join our fast-paced team.

This position reports to the Director, Quality Assurance and is part of the Quality department which is responsible for ensuring compliant management of product complaints associated with commercial OTC products. 

We are looking for a candidate who will be a long-term team member and become an integral part of a strong technical team.

Minimum Education or Experience Required:

• Bachelor's degree in Engineering, Chemistry, Biology, Pharmacy, or a related scientific discipline.
• Five (5)+ years of validation experience within an FDA-regulated pharmaceutical or OTC drug manufacturing environment.
• Two (2)+ years of supervisory or managerial experience leading a technical validation team.
• Experience in Quality Assurance batch record auditing, compliance, or validation.
• Experience in software configuration, installation and/or system integration.

Areas of Responsibility:

• Independently leads QA input to validation projects in support of commercial manufacturing for solid and liquid oral dose OTC products.
• Establishes and maintains the site Master Validation Plan (MVP), ensuring it aligns with business goals and FDA/OTC regulatory expectations for oral solids (tablets, capsules) and oral liquids (suspension, solutions).
• Provides input to project teams on strategy and direction of compliance/technical issues related to validation efforts to achieve compliance with company policies and government regulations.
• Reviews and approves validation documentation including specifications, protocols, and reports with a focus on cGMP impact, equipment qualifications (IQ/OQ/PQ), and validation lifecycle.
• Independently reviews commissioning and validation documentation for manufacturing equipment (e.g. fluid bed dryers, tablet presses, encapsulation machines, mixing tanks, and high-speed filling/packaging lines).
• Participates in validation project teams and provides guidance and direction from a regulatory compliance perspective.
• Actively and independently steers project teams to meet company policies and government regulations.
• Provides QA oversight/input to Computer validation projects in support of commercial manufacturing in a cGMP environment.
• Provides input into strategy and direction to project teams on compliance/technical issues related to cGMP computer validation efforts to achieve compliance with company policies and government regulations.
• Provides QA oversight on company eSystems validation project plans, validation protocols, traceability matrices, acceptance criteria, independent testing and/or assists in compiling data and results into final summary reports.
• Provides QA compliance guidance, training, and support to IT personnel and business users in their validation efforts to ensure continuous compliance.
• Provides QA oversight during the testing efforts of IT and business teams regarding requirements, resource planning, test coverage, and test strategies.
• Reviews proposed changes to validated computer systems and identifies the validation requirements necessary to maintain the system's validated state.
• Approves validated computer system-related change requests and provides QA oversight in Software Development Lifecycle (SDLC) documentation and maintaining 21CFR Part 11 compliance.
• Assists IT department in the design, review, and approval of test plans, test scripts, and test procedures.
• Reviews and approves computer validation change control activities in accordance with site procedures.
• Interacts with clients and regulatory investigators regarding compliance with computer system validation issues.
• Provides QA oversight of computer validation activities and generates SOPs and other documentation as required to maintain compliance.
• Assists in the modification and configuration of software applications based on user feedback and industry standards.
• Reviews training materials, including user guides, work instructions, and quick reference guides, to enhance the validation training experience.
• Works with trainers and subject matter experts to ensure that the training provided is effective and meets the needs of the participants.
• Provides QA compliance input on software usability to ensure that functionality is being utilized effectively.
• Leads root cause analysis investigations for validation-related deviations, Out-of-Specification (OOS) data, and Corrective and Preventive Actions (CAPA) related to solid/liquid batch failures or equipment malfunctions.
• Serves as the subject matter expert (SME) during FDA, third-party, and client audits, confidently defending validation designs, protocols, cleaning validation matrices, and/or data records

LNK provides competitive compensation and a full benefits package, including health and dental insurance and 401(k). Please forward your resume in confidence for immediate consideration.

The salary listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as permitted by law.

 

LNK provides equal employment opportunities to all applicants and prohibits discrimination of any type on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information or any other characteristic protected by applicable federal, state or local laws.

 

EOE M/F/D/V

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