Job Description

Job Title:

Associate II, Compliance

Job Grade:

G11A

Department:

Quality Assurance

FLSA Classification:

Non-Exempt

Manager's Job Title:

QA Compliance Section Head

Department Head Title:

Ohm QA & Compliance, CMO Head

Does This Position Have Any Direct Reports?

No

Approval Date:

October 1, 2021

Job Summary

The QA Compliance Associate is responsible for identifying deviations in the processes and ensure that all activities are cGMP compliant, identifying corrective actions, establishing path forward activities, and appropriate documentation.

Area Of Responsibility

Under limited supervision:

• Responsible for the handling of Product Quality Complaints (PQC) module.
• Responds to all stake holders calls for assistance, documentation and immediate corrective action associated with PQC.
• Facilitates the use of existing management processes regarding, investigations, and preventive actions.
• Performs assessments and ensures compliance with SOPs, Policies and Procedures.
• Shall coordinate with the cross functional teams for the investigations.
• Review the investigations and discuss with the Cross functional team for the correctness.
• Responsible for the complaint sample follow-ups.
• Responsible for the initial FAR assessment & Quality Alerts.
• Responsible to participate in the Product Recall process with the team.
• Responsible to follow up for the CAPA related to PQC;s with the cross functional teams.
• Responsible to prepare and up keep of PQC trending reports.
• Shall respond to customer needs immediately, ensuring appropriate corrective actions and process controls are in place.
• Communications and follow ups with CMO's related PQC for Investigation and relevant CAPA's
• Administration and management of investigation/PQC systems in Trackwise.
• Actively communicate with customers to facilitate continuous process improvement.
• May complete specific project work such as process improvement/remediation, maintain ownership and responsibility for specific QA processes.
• Any specific tasks assigned by the manager.

Work Conditions:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job in an office, lab, or manufacturing environment. The noise level in the work environment is usually moderate.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear. The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend.
• Must be capable of bending and lifting, moving and/or carrying up to approximately 20 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 0%

Education and Job Qualification

• Minimum of Bachelor's degree.

• Understanding of GMPs.
• Knowledge of statistical analysis using appropriate software and preparation of annual product review report.
• Knowledge and experience in approval process of Artwork Management System (AMS).
• Knowledge and experience in inspection and release of printed packaging material.
• Knowledge of stability requirement and adopting mechanism to collect stability samples as per SOP guidance.
• Knowledge of SAP transactions required for day to day activities.
• Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise or similar QMS, LMS (Learning Management System) etc.
• Knowledge of project management principles, practices, techniques and tools.
• Strong interpersonal and communication, both written and verbal, skills.
• Strong organizational and time management skills; must be able to prioritize and manage multiple assignments simultaneously.
• A self-starter with a hands-on approach and a can-do attitude.
• 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 six (6) years of experience within the pharmaceutical industry in quality function role.

• Experience working in an international multicultural matrix organization.