Job Description

Essential Functions / Key Responsibilities

Follow and maintain cGMP practices at all times.


Adhere to all safety norms and comply with company policies.


Ensure proper implementation and maintenance of SOPs and STPs.


Analyze Raw Materials, Packing Materials, In-process Samples, Intermediates, Finished Products, Stability Samples, Equipment Cleaning Samples, and Analytical Method Transfer Samples as per respective STPs and protocols using HPLC/Chemical analysis.


Perform daily temperature monitoring for all stability chambers and carry out stability activities as per Stability SOP.


Review raw data related to stability sample reports, protocols, chamber inward registers, and alarm monitoring registers.


Perform alarm verification as per respective SOP.


Prepare stability compilation reports, stability worksheets, report sheets, and stability protocols in accordance with product STPs and raw data.


Ensure proper online entries in instrument usage logbooks, inward registers, and laboratory records for respective plant batches.


Handle packing and initiation of stability samples.


Coordinate with external laboratories and send samples for outside testing, if required.


Report to the Section In-Charge / Authorized Designee.

Additional Responsibilities

Support compliance activities during audits.


Maintain proper housekeeping and documentation in the laboratory.


Coordinate with cross-functional teams when required.

Qualifications & Experience

0 to 2 years of experience in a Quality Control department, preferably in an API manufacturing unit.

Education

B.Sc / M.Sc in Chemistry or related discipline.

Skills Required

Basic knowledge of HPLC and chemical analysis.


Understanding of cGMP and laboratory safety practices.


Good documentation and communication skills.


Ability to work in a team and follow instructions accurately.