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Manager Quality Control

3 months ago

Ahmedabad, India Biotech Healthcare Full time

Role Objective:

A key objective of this role is to oversee and ensure the implementation of Good Practices within the Quality Control Department. They will be responsible for maintaining standard operating procedures (SOPs), conducting testing in adherence to written procedures and managing the analysis of various samples. Additionally, they will play a crucial role in method validation, calibration of instruments, training of personnel, and ensuring compliance with regulatory standards.


Desired Candidate Profile:

  • Bachelor's or master's degree in Organic Chemistry or Biochemistry, with a focus on analytical chemistry with minimum 10 years of experience in pharmaceutical Quality Control, with expertise on comprehensive understanding of analytical instrumentation and Good Manufacturing Practices (GMP).
  • Strong problem-solving abilities, excellent communication skills, and the capacity to work independently under pressure are essential qualities for this role.


Role Requirements:

Good Practices Maintenance:

  • Ensure adherence to Good Practices in the Quality Control (QC) department.

Standard Operating Procedures (SOPs):

  • Develop, implement, and follow SOPs in the QC department.

Ensure all testing procedures comply with written protocols or compendial methods.

Sample Management:

  • Plan and manage the daily analysis of samples, including raw materials, packaging materials, finished products, intermediates, in-process samples, stability samples, and routine analysis.

Perform sampling, analysis, and report results as required.

Oversee the proper destruction of leftover samples post-analysis.

Analytical Methodology:

  • Conduct Analytical Method Transfer (AMT) and Analytical Method Validation & Verification (AMV) as needed.

Prepare and maintain working standards, reference standards, and ensure their qualification.

System Registration and Reporting:

  • Ensure timely registration of samples in the system and prepare monthly reports.

Record raw data and analytical results accurately in analytical logs.

Training and Compliance:

  • Provide on-the-job training to new QC team members.

Ensure lab incidents, out-of-specification (OOS) results, out-of-trend (OOT) events, and any deviations are reported and logged for further investigation.

Instrument Calibration and Maintenance:

  • Ensure all lab instruments are calibrated before their due dates.

Prepare and review master calibration and preventive maintenance plans, as well as training schedules.

Stability Studies:

  • Prepare and review Stability Study Protocols, Hold Time Study Protocols, and Qualification Protocols as per defined procedures.

Manage stability chambers, sample loading, and analyze stability and hold time study samples.

Prepare stability summary reports.

Quality Assurance:

  • Review and ensure the adequacy and integrity of analytical and raw data.

Establish systems for the release or rejection of raw materials, intermediates, and packaging materials.

Software and System Qualifications:

  • Ensure all software and applications used in the QC department are qualified.

Participate in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.

Perform Audit Trail Reviews in the system.


Functional Skills:

  • Thorough knowledge of analytical instrumentation.
  • Comprehensive understanding of Good Manufacturing Practices (GMP).
  • Proficiency in method validation and analytical techniques.
  • Strong organizational and planning skills.
  • Excellent written, verbal, and interpersonal communication skills.
  • Demonstrated ability to work independently and efficiently manage multiple deadlines.


Behavioral Skills Required:

  • Strong problem-solving abilities.
  • Effective leadership and team management skills.
  • Attention to detail and accuracy in work.
  • Adaptability to changing priorities and environments.
  • Commitment to quality and compliance standards.


Team Size to be Manage:

  • Responsible for managing a team comprising 5 to 6 members, with the position reporting directly to the General Manager - Quality Control.


Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.