Job Description

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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

Location:
Ferring India Production