Location: Gangtok, Ranipol, Guwahati, Halol, Baska, Vadodara.

Execute Laboratory activities including Calibration/Qualification/PM of all instruments in QC Department, management of master calendars; procurement of working, reference and impurity standards, columns, reagents, chemicals and other items for QC laboratory; execution of Analyst Qualification for compliance with the objective to ensure adherence to GMP norms and timelines.

The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, Standard Operating Procedures (SOPs), and Sun Pharma Global Quality Policies, Standards and Procedures.

KEY RESPONSIBILITIES:

• Perform calibration of QC instruments as per calibration schedule.

• Coordinate preventive maintenance, break down, incident related issues and their respective documentation in QC Laboratory.

• Coordinate and support the service engineer during QC instrument preventive maintenance visits.

• Troubleshooting and rectification of breakdown of instruments.

• Analysis of the samples of working standard under qualification as per the requirements.

• Sampling of API associated with working standard qualification as per the requirements.

• On line instrument's calibration, status labeling and oversight of cleaning of instruments.

• Management of working, impurity and reference standards.

• Monitoring Reference Standards expiry based on the current catalog.

MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS:

Science or Pharmacy Graduates / Post Graduates / Equivalent

0 – 2 year with QC work experience preferred.

REQUIRED SUCCESS ATTRIBUTES:

• Knowledge of GxP’s, cGMP and other regulatory requirements.

• Attention to detail

• Initiative

• Learning Agility

• Compliance

SECONDARY SUCCESS ATTRIBUTES:

• Collaboration

• Effective Communication

• Passion

ROLES:

Additional responsibilities can be assigned as required.

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required.

DELEGATION OF RESPONSIBILITY:

In the absence of job holder, delegation of responsibility will be as follows:

Upward Delegation – Strategic site responsibilities to higher level

Downward Delegation – Operational responsibilities to direct reports or similar job role See Less