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

Execute laboratory activities including analysis of samples for assigned areas. For example, Raw Material (RM), In-process (IP), Packaged Material (PM), Intermediates, API (Active Pharmaceutical Ingredient) or Finished Goods (FG), Stability, Validation}. Report results in 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, and Sun Pharma Global Quality Policies, Standards and Procedures.

KEY RESPONSIBILITIES:

• Testing of samples as per assigned areas and as per approved test procedures

• Analyze the water samples for chemical analysis.

• Recording the analytical data in raw data sheet/protocol.

• Recording of instrument and standards usage in the respective log books/registers.

• Ensure compliance to GMP and safety standards in the QC laboratory & sampling Area.

• Identify & report Deviation and OOS.

• Ensure integrity, accuracy and adequacy of the analysis performed.

• Preparation and standardization of volumetric solutions and reagents.

• Handling sophisticated QC instrument such as HPLC, GC, UV, IR, etc.

• Operate the instruments and software associated with testing.

• Ensure working area is kept clean.

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

MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS:

Science or Pharmacy Graduates / Equivalent

0 – 5 year with QC work experience as per sub area, 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