Job Description

Job Summary

To perform the Qualification and Quality System audit of Active Pharmaceutical Ingredients (API) / Key Starting Material (KSM) / Primary & Printed Packaging Materials as per the Corporate Quality Audit program to ensure these manufacturing facilities/organizations are maintaining quality standards in compliance with cGMP standards and regulatory requirements.

Area Of Responsibility

• Manage Corporate Quality Audit program for North America (NA) for Vendors of API, Excipients, Key

Starting Materials and Primary Packaging Materials (Printed and un-printed).

• Prepare periodic audit schedules and plans for the North America and India regions in coordination

with the Commercial Department to confirm audit dates.

• Ensure execution of vendor audits as per audit schedule covering applicable regulatory requirements.
• Conduct audits to ensure compliance level according to applicable cGMP / Regulatory Requirements. To identify non-conformance with respect to Quality / Systems / Procedures / Operation against the respective regulatory requirement.
• Prepare and check adequacy of Audit Report and forward to Functional Head for further review and ensure corrections if any.
• Ensure audit reports are distributed to vendor within required timelines, as per respective procedure.
• Coordinate with Commercial Department for timely receipt of audit response/compliance from Auditee/Vendors.
• Ensure audit compliance received from auditee and verify appropriateness of CAPA, so as to close the audit in stipulated time line.
• Ensure formal audit closure report and close the audit.
• Ensure initiation of de-registration process for vendors that has critical GMP non-conformance during audits.
• Ensure ''for cause'' audits are executed on an as-needed basis.
• Ensure re-audits are executed for ''under observation/conditionally approved'' categorized vendors, and ensure CAPA re-audits are executed in case of critical observations as applicable within required timelines as per respective procedures.
• Establish Quality Agreements with suppliers, as necessary.
• Provide technical support to cross functional departments including Regulatory Affairs, R&D and Quality Assurance, as and when required.
• Implement KPI's to ensure the audit program is effective and meeting organizational objectives.
• Prepare Departmental Global Standards, Guidelines, and SOP's for approval.
• Follow and ensure compliance to code of conduct for "Auditor".
• Prepare Monthly report and submit to Functional Head.
• Attend training courses, conferences, and association meetings to continue to sharpen knowledge of current industry standards, trends and regulatory agency interpretations of GMP requirements.
• Participate in and support project work as allocated by reporting authority.
• Prepare and submit monthly reports.
• Highlight Key Audit Findings in monthly reports.

Work Conditions:

Corporate Office Environment located in a Manufacturing/Production and Warehouse Facility.

Physical Requirements:

• While performing the duties of this job the employee frequently is required to sit, stand; talk, hear, walk; use hands and fingers to operate a computer, telephone, keyboard and mouse. Light lifting up to 10lbs. is required.
• The physical demands 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. Stand, walk, sit, use hands and fingers to handle or feel, talk or hear, stoop, kneel, crouch or crawl
• Close and color vision

Travel Estimate

Up to 80%

Education and Job Qualification

• Minimum of a Master's degree in Pharmacy (PharmD) or pharmaceutical related science.
• Demonstrated excellent communication: verbal, written and presentation skills.
• A self-starter with a hands-on approach and a can-do attitude.
• A team building champion driving innovative cross functional synergies.
• Excellent project management and problem solving 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 twelve (12) years of experience in Pharmaceutical Quality Assurance and has sufficient experience in conducting GMP Audits of pharmaceutical product manufacturing organizations.