Manager-Quality Assurance

Role & Responsibilities: (Key accountability areas):

Responsible for review of:

• SOP's.
• Calibration and maintenance raw data, certificate of calibration.
• Calibration schedules.
• Qualification (including URS, Impact Assessment, Risk Management, etc.) and Validations Protocols / reports.
• Validation master plans.
• Executed DQ, IQ, OQ and PQ documents.
• Executed records.
• Responsible for ensuring compliance of qualification and validation activities.

• Reviewing / approving the Qualification (including URS, Impact Assessment, Risk Management, etc.) and Validations Protocols / reports and Validation master plans. Also responsible for reviewing the executed DQ, IQ, OQ and PQ documents. Ensure that overall Qualification activities are in line with defined SOP’s.

• Global QA/Regulatory Inspections:

• Actively participate in inspections.
• Drafting responses, collecting evidence.

• Handling of QMS activities:

• Participate in Investigations.
• Reviewing and approval the quality records related to deviations, OOS / OOT results, Change management.
• Ensure timely closure of quality records.
• Support in defining appropriate CAPA.
• Keep track on the records and ensure no records are overdue.

• Perform gap assessment of processes for continuous improvement.
• Document Management:

• Ensure master documents are controlled and archived in timely manner.

• Internal Audits:

• Organizing and conducting the internal auditing program as per schedule. Escalate any potential issues to the management, in timely manner.

• Ensure Quality Agreements with vendors are available. Monitor the performance of vendors on periodic basis.
• Training.

• Conduct periodic training on GMP/ Quality.
• Prepare training material / assessment questionnaire.
• Ensure there is no overdue training’s.
• Data Integrity.

Safety:

• Identification & reporting of Unsafe conditions.
• Report unsafe acts.
• Implement CAPA for any safety related concerns.

Key Technical Skills Required:

• Regulatory Knowledge regarding cGMP, FDA regulations, ICH guidelines, and other applicable standard like EU GMPs.
• Quality Management Systems (QMS).
• Equipment calibration, maintenance, technical know-how of utilities.
• Supplier management.
• Auditing and Compliance.
• Root Cause Analysis (RCA): Understanding and applications of tools such as A3 PPS, 6 M/Cause and effect analysis/ fishbone diagrams, 5 Whys, fault tree analysis, or other RCA methodologies.
• Quality Risk Management: Applications of QRM, and its implementation including tools such as FMEA (Failure Mode and Effects Analysis) and risk matrices.
• Hands on experience of Electonic systems.
• Data Integrity: Ability to detect and handle data integrity issues as per the regulatory expectations.

Key Behavioral Skills Required:

• Effective communication
• Collaboration and Teamwork
• Problem-Solving
• Leadership
• Resilience
• Critical thinking

Qualification/ Exposure/ Industry Experience:

• Bachelor’s degree in pharmacy or master’s degree in chemistry from a recognized university.
• 12-15 years of experience in quality assurance roles within the pharmaceutical or API manufacturing industry.

Preferred Skills:

• Laboratory compliance
• SCADA/DCS operations
• Lab information management system