Section Head - QA

Division

Department

Sub Department 1

Job Purpose

Direct and develop compliance to global and in-house quality standards to ensure that quality operations at site consistently achieve quality objectives of organization

Key Accountabilities (1/6)

Monitor and conduct internal inspections to evaluate adherence to cGMP and in-house standards as per procedures

• Conduct internal inspection
• Monitor the execution and closeout of internal inspections as per schedule
• Submit inspection report and checklist to unit QA
• Review the acceptability of compliance provided against the observations by units
• Evaluate trainee inspectors for certification purposes
• Provide assistance to corporate audit team in the form of document availability and justifications in lieu of observations

Key Accountabilities (2/6)

Monitor updates of Unit SOPs to establish robust quality system to meet current regulatory requirement and cGMP

• Review the list of identified procedures that need to be updated
• Monitor and review the updating of SOP monthly
• Review the quality of SOPs recommended by team
• Monitor closure of change request raised by user for updating SOPs
• Review the comments provided by users on corporate procedures (QA and QC) for acceptability and share the same with CQA

Key Accountabilities (3/6)

Control the system to analyse QMS documents for completeness and accuracy in line with cGMP requirements

• Review quality agreements with service providers to define the standards and responsibilities of Contract Giver/ Acceptor
• Deliver trainings on basic QMS systems to ensure adherence to cGMP requirements
• Understand requirements/ pre-requisites for implementation of software to prepare the implementation plan
• Monitor units to seek fulfilment of the plan
• Review and identify gaps between regulatory expectations as communicated by corporate and site level practices and communicate the status to the corporate team

Key Accountabilities (4/6)

Key Accountabilities (5/6)

Key Accountabilities (6/6)

Major Challenges

• Delay in initiation of updating of SOPs by User department which deviates the timeline as per procedure. Escalation to reporting manager and regular follow-ups.
• Lack of detailed compliance by user department resulting in a never ending review process. Regular trainings is provided to unit on writing compliance and communicating the expectation in terms of investigation, root cause, CAPA and impact analysis 

Key Interactions (1/2)

• Corporate QA to discuss the review comments on corporate procedures (daily basis)
• Unit QA to discuss the implementation of procedure and Change request (Daily)
• Users for procedures and compliance related discussions (weekly)

Key Interactions (2/2)

Dimensions (1/2)

• Span of control: 8
• Approx. 300 procedure revision in a year
• 0 overdue for revision of SOPs/Quality agreements
• 10 inspections to be performed in a year.

100% adherence to compliance

Dimensions (2/2)

Key Decisions (1/2)

Internal inspection compliance whether acceptable

Key Decisions (2/2)

Compliance, Training, SOP implementation, QMS (To units)

Education Qualification

B. Pharma/ M.Sc

Relevant Work Experience

• Minimum experience of 5-8 years in Pharma and 1 year as a team lead

Knowledge of cGMP, GDP, QA system, regulatory guideline                                                                               Good communication skills, Good presentations skills, team leader capabilities.                                                                            Supplementary requirement : Software computers : MS Office