Associate Validations | Pfizer | Vizag

Job Description

• Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.
• Determine process capability of new equipment through execution of approved protocols and assure defined parameters are incorporated into respective operating procedures and batch records.
• Assists with the development of validation protocols and manages Regulatory queries and responses.
• Participate in deviation investigations to identify root causes and define corrective and/or preventative actions.
• Adhere to all company and Good Manufacturing Practices {also cGMP} procedures, along with safety regulations within the plant, and participates in the development of validation programs as needed to remain current with cGMPs and industry.
• Work effectively as a member of the Quality Operations (QO) Good Manufacturing Practices {also cGMP} training team as well as directly with Business Area Training Leads / Coordinators and SMEs within Quality to support Good Manufacturing Practices {also cGMP} and site training initiatives.
• Report to the Validation Section Manager, the Validation Engineer will assure that equipment, facilities, and utilities are validated in accordance with {Current} Good Manufacturing Practices {part of GxP} principles, regulatory requirements, and company policies and standards.
• Work on summarization of data into concise reports that are reviewed by the QO product professional and approved by production and quality management.
• Define problems, collect data, establish facts, and draw valid conclusions.
• Work in a team environment to meet all team objectives and communicate progress on scheduled projects.

Qualifications

B.Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc/BE

2+ years of experience in quality assurance and /or validation function of sterile dosage form facility.

Must-Have

• Bachelor’s Degree
• Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc/BE
• Understanding of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations.
• Knowledge of validation principles and practices related to the following areas: manufacturing process, analytical method, cleaning methods, facility, equipment, instrument, utility system, and CSV systems.
• Conversant with design & working principles of key equipment used in sterile manufacturing –autoclave, tunnel, lyophilizers, homogenizers, filling machine, filter integrity testing devices.
• Well-versed with the Terminal process – design, execution, and review.
• Experience in plant and QC lab operations
• Good document written skills, with the ability to identify issues and recommend actions.
• Knowledge of current validation regulations in the industry.
• cGMPs and FDA, MHRA, TGA, MCC, etc. regulatory guidelines and validation principles.
• Excellent attention to detail and working knowledge of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices
• Excellent organizational skills, and ability to handle changing deadlines
• Strong communication with written and verbal skills
• Working knowledge of Microsoft Office, especially Excel for the evaluation of data

Nice-to-Have

• Technical writing experience
• Pharmaceutical Industry with laboratory process validation experience
• Working knowledge of equipment qualification and calibration specifically for laboratory equipment