Compliance and Qualification Manager

Job Title: Compliance and Qualification Manager

Department: Compliance

Location: Mumbai

Over view

The Compliance and Qualification Manager plays a crucial role in ensuring that a company’s operations and processes are in full compliance with industry regulations, standards, and internal policies. This position oversees the qualification and validation of systems, equipment, processes, and personnel, ensuring that they meet legal, safety, and quality requirements. The manager is responsible for maintaining rigorous compliance and qualification procedures to safeguard the organization's reputation and operational integrity.

Duties and Responsibilities

• Active participation in implementation of QMS as per ISO 9001:2015

• Preparation and review, Training & Launching of SOPs

• Prepare Presentation for management review meeting (Collection of Data, Records)

• To conduct Internal Audits

• Maintaining Records of SOPs, Change Control, Deviation, Accidents & Incidents, Audit Reports archive.

• Support in documentation for Risk assessment

• To Support reporting manager to complete the projects in stipulated time frame

• Preparation and Review of Qualification documents (URS, DQ, FAT/SAT, IQ, OQ)

• Preparation Site master file, Validation master, internal audit Plan.

• Follow up for compliance of internal or external audit observations.

• To arrange meeting and prepare MOM of the same.

• Education
  
  

  Any Graduate Engineer from Government Engineering College / Regional Engineering College (REC) / any other Engineering College of repute.

   

   

  Experience
  
  

  Min 8-10 years of total professional experience in compliance and qualification for pharmaceutical projects either with a pharmaceutical company’s technical organization or with an engineering/consulting company.