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Pharma Commissioning Qualification

2 weeks ago

Wagle Estate Thane Maharashtra, India Proworks Engineering & technical Services Pvt. Ltd. Full time

**1. **ELIGIBILITY & SKILL SET**

**KEY BEHAVIOURIAL COMPETENCIES**

Follow 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 measure and meet customer requirements / service level agreements.

Effective written and verbal communication skills in English Language.

Shall have to travel & visit at 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 weakness 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 point 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 redirects 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 Task, Roles & responsibilities)**

Prepare/ Check Internal Policies, Standard operating procedures, Standard Design Guidelines

**2. **ROLES & RESPONSIBILITIES**

**ROLE/RESPONSIBILITIES (related to routine task)**

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 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 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 site.

Compile Final Validation documentation package.

Perform and support QA functions of Department

Plan subtask for self and subordinates and remain accountable for overall manhour expenses.

Conduct FAT, inspection of set-up / prepare Gap analysis report for core area of competence.

Conduct GxP Audits

Routine Correspondence with clients and all project stake holders effectively & impressively

Internal Correspondence (written) within 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 need for the team members and develop them for scope services

Keep the team motivated and remain responsible for team performance

**TECHINCAL SKILLS / COMPETENCES**

Knowledge and understanding of International Regulatory Guidelines and Regulatory requirements for CQV (USFDA, EU, ISPE, ICH etc.)

Experience of 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 qualification point of view.
- Process equipment.
- HVAC system.
- Clean utility systems.

Experience of leading a team

Read and understand isometric, P&ID and as built drawings.

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹40,000.00 - ₹75,000.00 per month

Schedule:

- Day shift

**Experience**:

- total work: 7 years (preferred)
- CQV: 5 years (preferred)

**Speak with the employer**
+91 9769678889