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

Execute sampling in the assigned area {for example, Raw Material, Retest materials, intermediate and Packing Material from warehouse, pasting of container label for approval /rejection}. Perform pasting of container label for approval /rejection.

Manage stability samples with respect to charging & withdrawal with the objective of achieving targets as per GMP and regulatory requirements and ensure sampling is done in adherence to GMP requirements 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, and Sun Pharma Global Quality Policies, Standards and Procedures.

KEY RESPONSIBILITIES:

• Perform sampling of raw materials, retest materials, intermediate, PM from WH in line with Standard Operating Procedures.

• Maintain sampling tools & instruments in line with Standard Operating Procedures.

• Document and maintain records for sampling as per procedures.

• Perform affixing of container labels for quarantine, approval / rejection as applicable

• Ensure integrity, accuracy and adequacy of the relevant documents during sampling.

• Manage charging and withdrawal of stability samples as per schedule and relevant documents in line with standard operating procedures.

• Identify & report deviation observed during sampling and other activities.

• Ensure working area is kept clean.

• Follow the EHS policy, laboratory procedures and maintain the compliance to GMP requirements.

MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS:

Science or Pharmacy Graduates / Equivalent

0 – 2 year with QC sampling work experience preferred.

REQUIRED SUCCESS ATTRIBUTES:

• Knowledge of GxP’s, GMP 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