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Validation Project Associate


Visakhapatnam, AP 530003
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Job Details

**Preferred Qualification**

B.Pharm/M.Pharm /M.Sc/BE / MBA

**Target years of experience**

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

**Technical Skills**

+ Project Management

+ Pharma Industry Awareness

+ Validation Lifecycle management

+ Risk Management lifecycle understanding

+ Understanding of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations

+ Knowledge of basic 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, Vail filling, filter integrity testing devices

+ Good document review and approval skills, with ability to identify issues and recommend actions

**Standards, Processes & Policies**

+ cGMP and basic understanding of quality management systems

+ Good documentation practices

+ Technical writing and document review skills

+ Basic understanding of validation regulations in the industry


**Any Other Skills**

+ Be highly organized and a good multi tasker

+ Excellent Planning and Co-ordination skills

+ Strong attention to details

+ Strong leadership, organizational planning and project management skills, in addition to strong technical background required to coordinate multi-disciplinary teams

+ Analytical thinking to grasp complex technical issues and provide feasible solutions

+ Ability to communicate effectively with all levels within the organisation

+ Excellent interpersonal effectiveness and communication skills (written and oral) required to interface across departments and management levels

+ **Technical** **Skills** : During conceptual planning of a project, draft a plan incorporating input from key stakeholder to identify a representation of the actual requirements and timeline of a project. As the project develops, prepare a detailed project timeline plan using appropriate project tracking tools and work with Validation, manufacturing and business owners to assign a cost and time schedule for the project. Develop implementation plan, evolve with contingency options and interact with the team for risk identification, plan for mitigation throughout the project lifecycle. Be an effective leader in the removal of identified risks and potential issues. Partner with MSAT in Tech Transfer of planned molecules and synch schedules with Planning. Monitoring the overall scheduling and costs of the project. Leading various stage gate review meetings and tech review meetings along with the cross functional teams to update the plan / progress of the project. To closely co-ordinate with various departments for facilitating information and deliverables for dependent activities Follow up with Validation and other departments for material requirements for Qualification related activities Develop cost database of projects Develop and maintain the knowledge data bank of technical and functional outputs of the projects Establish Milestones for planned goals and objectives in the year. Report progress against goals/milestones in the year.

+ **Communication**

+ Leverages a variety of communication tools and techniques to help colleagues understand how their work aligns to business / Validation Projects priorities

+ Presents Validation project issues across department

+ **Influencing Others**

+ Leads projects that implement strategic direction for the validation concepts & projects and may impact multiple Pfizer network sites.

+ Influences senior management decisions that have an impact on business direction within Validation team.

+ Partners with Pfizer network sites to accomplish validation objectives.

+ **Managing Change**

Anticipates and manages change that has a substantial impact on the validation projects and strategy; prepares group for change

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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