Sr. Executive-DQVC

1.   To study and understand the project quality and documentation requirements from the project brief with the help of the project design team.

2.   To prepare the project and quality plan for all the ongoing projects.

3.   To prepare the document list based on the project scope, project timeline, and quality plan, including internal and vendor-provided documents.

4.   To inform all relevant departments about the documentation and quality requirements.

5.   To collect, prepare, review, modify, and approve documents related to procurement, installation, commissioning, qualification, validation, and handover using standard tools and software.

6.   To track all documents for availability, correctness, and approvals from the project team, concerned departments, and clients.

7.   To prepare critical qualification and validation document requirement specifications (URS), validation master plan (VMP), project and quality plan, impact analysis, corrective action and preventive action (CAPA), standard operating procedures (SOPs), risk analysis, etc.

8.   To prepare and update standard templates for design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), handover forms, installation protocols, commissioning protocols, etc.

9.   To maintain the document history and change logs throughout the project life.

10.To verify the documents and drawings for numbering, formats, signature panels, approvals, etc.

11.To coordinate with the client for document approvals, maintain records, and confirm receipt and version control.

12.To follow up on all site activities documentation related to installation, commissioning, qualification, validation, and handover. To perform the site as required If needed, visit the.

13.To track and send protocols to the site as per testing and reporting needs.

Supervisory Role:

1.    To prepare a work plan and work hour list for all new projects within the heating, ventilation, and air conditioning (HVAC) department.

2.    To regularly update the plan and work hour list and get the same approved by the project team and superiors.

3.    To allocate workload to team members as per project needs and deadlines.

4.    To coordinate with the project management department team on client queries and documentation timelines.

5.    To review and approve the workload and deliverables of subordinates for accurate submission of documents required for purchases, client approvals, construction at sites, etc.

6.    To ensure that all the department reports are updated on a timely basis.

7.    To ensure that all the documents, internal and external, are accurately organized in the data management system (DMS) as per the project requirements and plan.

Requirements

Skills and Competencies:

1.    Good understanding of the basic concepts of HVAC, clean room construction, clean room flooring, piping, utilities, production equipment, and electrical systems.

2.    Fluent in written and spoken English and Hindi.

3.    Self-motivated and target-oriented.

4.    Capable of drafting SOPs and templates aligned with GMP and regulatory requirements.

5.    Strong analytical and logical reasoning skills.

6.    Competent with spreadsheets and document tracking tools.

7.    Ability to perform under pressure and meet strict deadlines.

8.    High accuracy in documentation and effective time management.

Knowledge:

1.    Knowledge of the pharmaceutical industry in general, dosage forms in the formulation industry, and various equipment and systems that go into the operation and construction of a facility.

2.    Knowledge of the latest Food and Drug Administration (FDA) and international good manufacturing practice (GMP) documentation standards.

3.    Good knowledge of qualification and validation documentation for a pharmaceutical facility.

4.    Attending and representing the company in GMP audits, inspections by FDA agencies, and practical validation on the production floor would be an added advantage.