Analyst - Documentation

Prepare, review and execute the analytical documents of QC for compliance with the objective of achieving targets as per GMP and regulatory requirements to ensure quality of product testing and release 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:

· Entry and configuration of QC Master Documents such as Specifications and ATP [For Raw Materials, Working Standards, Finished, Stability and Packing Materials etc.] into LIMS.

· Maintenance of documented activities related to issuance and retrieval of records.

· Preparation of new methods and formulas in LIMS as per requirements.

· Development and execution of Pharmacopeia Changes report based on Verification of Pharmacopeia Methods raw data.

· Revision of Sp

Prepare, review and execute the analytical documents of QC for compliance with the objective of achieving targets as per GMP and regulatory requirements to ensure quality of product testing and release 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:

· Entry and configuration of QC Master Documents such as Specifications and ATP [For Raw Materials, Working Standards, Finished, Stability and Packing Materials etc.] into LIMS.

· Maintenance of documented activities related to issuance and retrieval of records.

· Preparation of new methods and formulas in LIMS as per requirements.

· Development and execution of Pharmacopeia Changes report based on Verification of Pharmacopeia Methods raw data.

· Revision of Specifications as per Pharmacopeia changes Report.

· Development and maintenance of Quality Control SOPs as per Global Quality Standards requirements.

· Execution of Certificate of Analysis for RM/PM/FP sections.

· Submission of Specification/ ATP for dossier filing and re-filing to Regulatory Authorities department.

· Initiation of change control records for SOPs, Specification, ATP and Qualification of new QC Instruments.

· Execute CAPA associated actions items as per observations given by functional departments and implement them in the associated Standard Testing Procedures.

MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS:

Science or Pharmacy Graduates / Post Graduates / Equivalent

0 – 2 years of QC work experience preferred

REQUIRED SUCCESS ATTRIBUTE:

· Knowledge of GxP’s, GMP and other regulatory requirements.

· Attention to details

· 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