Pharma Job : Validation Project Associate Vacancy @ Pfizer

Pharma Job : Validation Project Associate Vacancy @ Pfizer

BPharma and MPharma candidates with relevant experience is invited to apply for a Validation Project Associate position that is available at Pfizer. Interested and eligible candidates are requested to check out all of the relevant job details goven below:

Job Title:    Validation Project Associate

Qualifications: 

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

Behavioral/ 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

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