MANAGER – CQV – JOBS 2022 at Proworks Engineering And Technical Services Pvt. Ltd. Apply with CV – info@proworksengg.com

JOB DESCRIPTION

MANAGER – CQV

Click here for JOB Description

JOB Opportunity for Manager and Executives

ELIGIBILITY & SKILLSET

KEY BEHAVIOURAL COMPETENCIES

• Follow the Code of Ethics set by the company
• Be Punctual
• Ability to work under pressure and withstand stress
• Demonstrate Professionalism
• Willing to take tough (non-populist) measures when required, Separates Professional and Social
  relations )
• Ability to plan sub-tasks very well based on an activity allocated
• Ability to establish measures and meet customer requirements/service level agreements.
• Effective written and verbal communication skills in the English Language.
• Shall have to travel & visit any site as per project requirement.
• Must be able to work in varying hours/days.
• shares knowledge and expertise so others can learn and benefit
• Recognizes own strengths and weaknesses and uses this knowledge to aid affective teamwork
• Acknowledges other’s skills and accomplishments
• Resolving differences
• Communicates thoughts and feelings to promote discussion and prevent escalation of conflict.
• Express disagreements and feedback constructively
• Listen to others’ points of view
• Works towards joint solutions both inside and outside the team
• Takes independent and immediate actions to solve problems and help others
• Keeps pace with high volumes of work when necessary
• Adapts to work style and priorities of others
• Tracks progress and task and redirect effects to ensure deadlines and quality standards are met
• Anticipates bottlenecks and takes actions to prevent problems
• Fosters an environment of support and cooperation amongst all staff
• Appreciates other contribution

SOFTWARE COMPETENCES

• Microsoft Word
• Microsoft Excel
• Microsoft Project
• Microsoft PowerPoint
• AUTHORITIES (other than Routine tasks, Roles & responsibilities)
• Prepare/ Check Internal Policies, Standard operating procedures, and Standard Design Guidelines

ROLES & RESPONSIBILITIES

• ROLE/RESPONSIBILITIES (related to the routine tasks)
• Comprehend and implement internal standards & Guidelines while delivering any job task
• Prepare/Review GMP documents (VMP, RA, URS) as per the international regulatory requirement for
  the following equipment and systems of Oral Dosage, Injectable and Biotech formulation facility.
• Process equipment.
• HVAC system.
• Clean utility systems.
• Prepare Qualification protocols (DQ, IQ, FAT, OC, PQ) as per the international regulatory requirement
  for the following equipment and systems of Oral Dosage, Injectable and Biotech formulation facility.
  Process equipment.
• HVAC system.
• Clean utility systems.
• Prepare/Review Commissioning Protocols/checklist for Utilities
• Standardization of validation documents.
• Supervise/witness qualification process at the site.
• Compile the Final Validation documentation package.
• Perform and support QA functions of the Department
• Plan subtask for self and subordinates and remain accountable for overall manhour expenses.
• Conduct FAT, an inspection of set-up/prepare Gap analysis report for the core area of competence.
• Conduct GxP Audits
• Routine Correspondence with clients and all project stakeholders effectively & impressively
• Internal Correspondence (written) within the department
• Independently Clarify Client queries/comments technically in line with the regulatory / Standard
  international/ local guidelines
• Project Monitoring & Control
• Prepare and submit monthly Reports
• Activity & Resource Planning
• Billing as per projections
• Set PBIS/KRA for team
• Identify training needs for the team members and develop them for scope services
• Keep the team motivated and remain responsible for team performance

TECHNICAL SKILLS / COMPETENCES

• Knowledge and understanding of International Regulatory Guidelines and Regulatory requirements for
  CQV (USFDA, EU, ISPE, ICH etc.)
• Experience in preparing qualification protocols for API, Oral Dosage, Injectable and Biotech formulation
• Basic understanding of the following equipment and systems of API, Oral Dosage, Injectable and
  Biotech formulation facility from a qualification point of view.
• Process equipment.
• HVAC system.
• Clean utility systems.
• Experience in leading a team
• Read and understand isometric, P&ID, and as-built drawings.

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