The Quality Assurance Manager oversees QA compliance, calibration, validation, auditing, and training within pharmaceutical manufacturing, ensuring adherence to regulatory standards.
Job Description:
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
Top Skills
Cgmp
Dcs
Eu Gmps
Fda Regulations
Fmea
Ich Guidelines
Quality Management Systems
Rca Methodologies
Scada
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