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
