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. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post : Sr. Executive - Validations / Validation specilist
Roles and Responsibilities:
- 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, homogenisers, isolators, filter integrity testing devices
- Well versed with Terminal process – design, execution and review.
- Experience in plant and QC lab operations
- Good document review skills, with ability to identify issues and recommend actions
- Knowledge on the Qualification instruments and Tools.
- Knowledge on the Components level assessment, PM requirement.
- Good knowledge on the Validation instruments calibration
- Knowledge on the assessment of the Change controls and failure investigations.
Candidate Profile :
Preferred Qualification: B.Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc.
Target years of experience: 6+ years’ Experience in validation function of sterile dosage form facility.
- Execute project and routine validations and compile results
- Execute validation of manufacturing equipment, Visual inspection equipment and packing equipment in accordance with regulatory requirements, cGMPs, corporate policies and procedures and as per schedule
- Operation and Calibration of Validation Instruments and Accessories
- Coordinate and plan validation activities with Manufacturing, QC, Microbiology and Projects
- Compile validation documents and results
- Ensure revalidations are performed within the established intervals.
- Knowledge on the Terminal sterilization and fill finish line qualifications.
- Writing and review of SOPs pertaining to Equipment operation, cleaning and maintenance; Provide feedback if need be
- Develop facility qualification reports
- Knowledge on the Validation concepts and ability to train the people.
- Preparation of the traceability matrix.
- Review of DQ, FAT/SAT activities/documents
- Participation and review of IQ/OQ/PQ protocols and Reports
- Review and investigation of qualification deviations
Assist / Deputy Manager/ Manger – Validation in performing the following
Perform Risk assessment to establish the scope and extent of validation activities
Prepare and review impact assessment documents
Number of Equipment/Instruments in coordinating with user departments
Number of Qualification Documents.
Adherence to Safety Procedures/GMP & GDP Practices
Industry Type: Pharma
Last date: 25th Febaury, 2018
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