QA Director – Site Investigations & Quality System

Job Description

POSITION SUMMARY:

This position is responsible for overall adequacy of all non-conformances investigations logged at site in respect to local and global procedures as applicable. Ensuring that the non-conformances are thoroughly investigated, root causes are substantiated, adequate and effective CAPA’s are implemented.

Is able to identify any atypical product quality trend and escalate in a timely manner to site and corporate level. This position will be an extension to implement corporate investigation and harmonization strategies and will represent the site.

Has been involved in handling USFDA inspections, responding to observations and well versed with Regulatory requirements. Under the direction of the Senior Director of Quality, this position is also responsible for implementing and managing the systems related to GxP compliance which includes, but is not limited to, the following systems: Document Control, Electronic Quality Management Systems (Investigation, Change Control, CAPA) and Annual Product Review (APR).

JOB RESPONSIBILITIES:

Financial:

• Participate in preparation of Revenue and Capex Budget. Ensure financial prudence in resource planning, allocation, and management within approved budgets while building the site's best-in-class quality processes and systems.
• Maintain quality system controls to ensure no critical and major market complaints.

Operational Excellence:

• Handling of QMS documents like Quality Event/ deviation investigation, Change Control, APR etc.
• Review of QMS documents such as OOS, OOT, Incidents deviation, CAPA
• Performing Root Cause Analysis of an occurred OOS, deviation/ a typical event of or Failure investigation using investigation tools viz. Fishbone diagram, ‘5 WHY’ Analysis, IS – IS NOT Analysis, Peeling the Onion, Process Mapping / Flow Charts, Interviews and brain storming
• Reviewing the adequacy of CAPA’s with respect to the root cause investigations. To verify if the CAPA effectiveness check is well defined
• Responding to Internal and external audit observations with respect to investigation related observations. Serve as site representative for Quality Systems during regulatory inspections and corporate audits
• To be able to identify and notify atypical product quality trends while review of investigations. Lead and develop quality systems personnel and drive quality culture for the site.
• Establish, revise, review and continuously improve procedures for all Quality Systems and serve as coordinator for implementation of global policies and procedures at the site.

Stakeholder:

• Responsible for coordination with Production/R&D/QA/QC/Validation for various activities
• Lead and coordinate with stakeholders for APR activities
• Periodic review of SOP’s of QA/Production/Warehouse/QC/Validation/IT etc.

Innovation:

• Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements.
  

Education :

Bachelor of Pharmacy or relevant science degree

Knowledge And Skill:

15-25 years in Pharmaceutical Industry - Investigations, Sterile Manufacturing Quality Assurance, Validation and Qualifications, Quality System and Compliance, Auditing, Good Distribution Practices, Sales and marketing