Quality Control Laboratory Manager

Title : QC- Chemist

Company : Sinterx Pharma Private Limited

Location : Valigonda, Choutuppal.

Position Description :

The

QC Chemist

with

5 to 8 years of experience

is responsible for leading and executing complex analytical testing of API intermediates to ensure compliance with predefined quality standards and regulatory guidelines. This role includes conducting advanced testing, reviewing analytical data, supporting investigations, mentoring junior analysts, and contributing to continual improvement initiatives. The QC Chemist plays a key role in maintaining product quality throughout the production lifecycle by collaborating closely with Quality Assurance, Production, and R&D teams.

Educational Background :

Bachelor’s or Master’s Degree in

Chemistry ,

Pharmaceutical Sciences , or

Life Sciences

Work Experience : 5 to 8 years

of experience in

Quality Control

within the

API or API Intermediate manufacturing industry

Hands-on experience in

instrumental analysis

(HPLC, GC, UV, IR, KF, etc.) and

wet chemistry

techniques

Strong understanding of

regulatory guidelines

(GMP, ICH, FDA, etc.) and

data integrity practices

Key Responsibilities :

Perform routine and non-routine analysis of

raw materials, intermediates, and in-process samples

using validated methods and instruments.

Conduct

instrumental analysis

using

HPLC, GC, UV, FTIR, KF , and ensure proper calibration and maintenance.

Review and interpret analytical data, ensure compliance with internal specifications and regulatory standards.

Identify and investigate

deviations, OOS / OOT results , and support

CAPA

implementation in collaboration with QA.

Lead or assist in

method validation, method transfer , and

stability studies

for intermediates.

Ensure strict adherence to

GMP, GLP, and ALCOA+

principles in all documentation and laboratory practices.

Maintain and review laboratory documentation including

test records, logbooks, equipment usage logs , and

analytical reports .

Support internal and external audits by preparing necessary documentation and responding to audit findings.

Provide technical support and

training to junior analysts , ensuring adherence to safety, quality, and compliance standards.

Collaborate with

Production, QA, AR&D, and Regulatory Affairs

for continuous improvement and troubleshooting.

Required Skills :

Advanced analytical and problem-solving skills

Proficiency in handling and troubleshooting analytical instruments (HPLC, GC, etc.)

In-depth knowledge of

ICH guidelines ,

GMP regulations , and

data integrity principles

Strong documentation and reporting abilities

Ability to work independently and as part of a cross-functional team

Experience in investigation and risk assessment processes

Familiarity with LIMS, Empower, or similar laboratory data systems (preferred)

Key Attributes :

Detail-oriented with a focus on data accuracy and compliance

Good communication and interpersonal skills

Ability to handle multiple tasks and meet deadlines in a fast-paced environment

Commitment to continuous learning and process improvement

If you are Interested in the job Position, forward your resume to hr@sinterxpahrma.co