Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Executive - Validation
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 development of validation protocols and manage 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 developments 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 is reviewed by the QO product professional and approved by production and quality management.
• Define problems, collect data, establish facts, and draw valid conclusion.
• Work in a team environment to meet all team objectives and communicate progress on scheduled projects.
Candidate Profile
• Bachelor In Pharmacy / Masters In Pharmacy / M.S (Pharmacy)/ M.Sc Graduate/BE
• 0 - 5 years experience in quality assurance and /or validation function of sterile dosage form facility.
• Understanding of pharmaceutical manufacturing, packaging, quality assurance 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, lyophilizes, homogenizers, filling machine, filter integrity testing devices.
• Well versed with Terminal process - design, execution and review.
• Good document written skills, with ability to identify issues and recommend actions to identify issues and recommend actions.
Nice-to-Have
• Technical writing experience
• Pharmaceutical Industry with laboratory process validation experience
• Working knowledge of equipment qualification and calibration specifically for laboratory equipment
Additional Information
Qualification : B.Pharm, M.Pharm, M.Sc, B.E
Location : Vizag
Industry Type : Pharma/ Healthcare / Clinical research
Functional Area : Validation
End Date : 30th April, 2021
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