QA & QC Manager

3 days ago

Mumbai, Maharashtra, India Aquatic Remedies Pvt Ltd Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Aquatic Remedies Pvt Ltd is a pharmaceuticals company based in Mumbai, Maharashtra, India. Aquatic Remedies Pvt Ltd focuses on research, development, and manufacturing of high-quality pharmaceutical products. The company is committed to ensuring the highest standards of health and safety in their products and operations.

Role Description

We are seeking a dedicated and experienced
QA & QC Manager
to oversee quality assurance and quality control operations within our pharmaceutical manufacturing facility. The ideal candidate will ensure that all products meet the highest standards of quality, safety, and regulatory compliance. This role involves developing and maintaining quality management systems, conducting audits and inspections, managing documentation, and collaborating across departments to uphold GMP standards.

Key Responsibilities:

  • Oversee and manage all
    Quality Control (QC)
    activities related to raw materials, in-process samples, and finished product testing.
  • Ensure full compliance with
    cGMP
    ,
    NAFDAC
    , and other applicable
    regulatory guidelines
    .
  • Supervise laboratory operations, including
    stability studies
    ,
    method validation
    , and
    environmental monitoring
    .
  • Investigate
    out-of-specification (OOS)
    results and deviations, perform
    root cause analysis
    , and implement effective
    corrective and preventive actions (CAPA)
    .
  • Collaborate with
    QA, Production, R&D, and Regulatory Affairs
    teams to support product release and regulatory submissions.
  • Maintain, calibrate, and verify analytical instruments such as
    UV-Vis spectrophotometers
    and
    dissolution testers
    .
  • Prepare for and actively participate in
    regulatory inspections and internal/external audits
    .
  • Conduct
    training sessions
    for QC personnel on SOPs, safety, and compliance standards.
  • Ensure accuracy and integrity of
    Batch Manufacturing Records (BMRs)
    , laboratory data, and all quality documentation.

Qualifications & Skills:

  • Bachelor's degree in
    Pharmacy, Chemistry
    , or a related discipline.
  • Proven experience in
    Quality Assurance (QA)
    and
    Quality Control (QC)
    within the
    pharmaceutical industry
    .
  • In-depth knowledge of
    GMP regulations
    and
    regulatory compliance
    standards.
  • Strong analytical and problem-solving abilities.
  • Excellent communication, interpersonal, and team management skills.
  • Proficiency in conducting
    audits, inspections, and documentation control
    .
  • Hands-on experience with
    quality management systems (QMS)
    and related tools.
  • Experience in
    training and mentoring
    staff on quality standards and best practices.

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