603965 - SrAssociat Valid&Qualifications

Job Description

ROLE SUMMARYResponsibilities include design, plan and participate in the qualification activities. Coordinate with cross functions to complete the activities on time and in smoother way. (Individual Contributor only).ROLE RESPONSIBILITIES Key AreasActivitiesDesign and document writing skills:

• Can be able to develop and write validation Master Plan (VMP) for the new facilities and periodic updation.
• Can be able to develop and write Project validation plans preparation and updation.
• Can be able to develop and write Approval of Validation protocols for equipments.
• Validation acceptance criteria, and ensure in accordance with Regulatory guidelines, corporate policy and industry standards.
• Participate in design of the systems.
• Prepare the system assessments and reports.
• Writing and review of SOPs pertaining to Equipment operation, cleaning and maintenance; Provide feedback if need be.

Execution participation:

• Execute validation of manufacturing equipment, Visual inspection equipment, packing equipment, Lab equipment , Utilities, Process validation and Cleaning Validation in accordance with regulatory requirements, cGMPs, corporate policies and procedures and as per schedule.
• Operation and Calibration of Validation Instruments and Accessories.
• Execution and review of IQ/OQ/PQ protocols and Reports.
• Coordination of validation execution with CFT.
• Participate, Review and compilation of the documents
• Compile validation documents and results.
• Ensure revalidations are performed within the established intervals.
• Knowledge on the process equipment, Utility equipment and Lab equipment qualifications.
• Coordination of validation execution with CFT.
• Performing Alarm assessment during qualification.
• Knowledge on the Validation concepts and ability to train the people.
• Performs Data analysis and review.
• Review and investigation of qualification deviations.
• Adherence to Safety Procedures / GMP & GDP Practices.

Influencing Others:

• Influences senior colleague decisions that have an impact on business direction within Validation Team.
• Partners with Pfizer network sites to accomplish Global validation objectives.
• Interact with various external calibration agencies/ vendors for procuring standard instruments.

ESSENTIAL REQUIREMENTSPreferred Education/ Qualification (Eg. Diploma, Certificates, bachelor s degree, Master s Degree, licenses, technical certification)B.Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc/ BEExperience :5 years of experience in quality assurance and /or validation function of sterile dosage form facility.Core Competencies :

• 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 and Processes, cleaning Validations.
• Well versed with Terminal process design, execution and review.
• Experience in plant and QC lab operations.
• Good document review skills, data analysis 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.

Standards, Processes & Policies

• Knowledge of current validation regulations in the industry.
• cGMPs and FDA regulatory guidelines and validation principles.

DESIRABLE REQUIREMENTS:

• Interdisciplinary collaboration.
• Pharmaceutical expertise.
• Organization of care practice.
• Personal development.

Additional Desirable Requirements :

• Strong Technical skills, leadership, organizational planning and project management skills, in addition to strong technical background required to coordinate multi-disciplinary teams.
• Strong interpersonal skills.
• Excellent interpersonal effectiveness and communication skills (written and oral) to interface across departments and management levels.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control #LI-PFE,

Keyskills :
data analysisprocess designquality controldocument reviewtechnical skillsquality assuranceprocess validationcleaning validationmanufacturing processregulatory guidelineslegislative relationsregulatory requirements