Senior Quality Control Manager

Biotech Vision Care; Ahmedabad District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Biotech Vision Care is seeking a senior professional to lead Quality Control with emphasis on GMP compliance, SOP maintenance, and analytical method validation. The role includes overseeing testing of raw materials, in-process samples, and finished products, plus instrument calibration and staff training in a fast-paced environment.

You will drive AMT/AMV, ensure data integrity, and manage stability protocols while coordinating with QA and production to ensure timely reporting and regulatory

Qualifications

• Requires 12–14 years of experience in pharmaceutical QC/medical devices and GMP

Responsibilities

• Ensure Good Practices in QC and adherence to SOPs.
• Oversee sampling, testing, and analysis of materials and finished products.
• Manage AMT/AMV, standards preparation, and instrument qualification.
• Prepare monthly reports and maintain data integrity in logs.
• Provide on-the-job training and ensure deviations are investigated.

Skills

Analytical instrumentation

GMP knowledge

Method validation

SOP development

Training & mentoring

Documentation & data integrity

Education

Bachelor's or Master's in Organic Chemistry or Biochemistry

Job description

> 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 12-14 years of experience in pharmaceutical Quality Control/Medical Device, 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.

> Roles & Responsibilities:

1. Good Practices Maintenance:

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

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

2. Standard Operating Procedures (SOPs):

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

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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:

• Reports to: AGM QC.
• Team Structure: Responsible for managing a team of 7–8 members.

ImportantLinks

• Website: https://biotechhealthcare.com/
• LinkedIn: https://www.linkedin.com/company/biotechhealthcare/
• Instagram: Biotech Vision Care

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