Quality Control Laboratory Manager

Title:QC- Chemist

Company: Sinterx Pharma Private Limited

Location: Valigonda, Choutuppal.

Position Description:

QC Chemist

Educational Background:

Chemistry

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