Quality Control Laboratory Manager

1 week ago

Valigonda Telangana, India SinterX Pharma Private Limited Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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

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