Quality Control Manager

Job Title:Quality Control Manager

Location:Daman

Job Summary:

The Quality Control Manager is a senior leadership position responsible for directing all laboratory operations related to the testing of raw materials, packaging materials, in-process materials, and finished pharmaceutical products. This role ensures that all quality control activities are conducted in strict compliance with current Good Laboratory Practices (GLP), and all applicable national and international regulatory standards . The successful candidate will drive the strategic direction of the QC function, ensuring high-quality, timely analytical support for manufacturing and product release.

Responsibilities:

1.Analytical Testing:

Perform routine and non-routine analytical testing of raw materials, in-process samples, finished products, stability samples, and packaging materials using various analytical techniques (e.g., HPLC, KF, Dissolution, Titration, Physical testing).

Ensure all testing is conducted in accordance with approved pharmacopoeial methods and in-house specifications.

Operate, calibrate, and maintain analytical instruments, ensuring their optimal performance and readiness for testing.

2.Data Review & Documentation:

Thoroughly review analytical data, raw data, and laboratory notebooks for accuracy, completeness, and compliance with established procedures and regulatory requirements.

Prepare and review Certificates of Analysis (COAs) and other relevant quality documents.

Ensure timely and accurate documentation of all testing activities, results, and observations.

Maintain detailed and organized laboratory records.

3.Investigations & Deviations:

Participate in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, identifying root causes and recommending corrective and preventive actions (CAPAs).

Document and investigate laboratory deviations, ensuring adherence to established procedures.

Support the implementation and verification of CAPAs.

4.Method Development & Validation Support:

Assist in the development, transfer, and validation of analytical methods as per regulatory guidelines.

Conduct feasibility studies and provide technical input for method optimization.

5.Compliance & Audits:

Ensure strict adherence to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and other applicable regulatory guidelines

Participate in internal and external audits (e.g., regulatory inspections, customer audits) by providing necessary documentation and technical support.

Address audit observations and implement corrective actions.

6.Training & Mentorship:

Train junior QC analysts on analytical techniques, instrument operation, and laboratory procedures.

Serve as a technical resource for other team members.

7.Safety & Housekeeping:

Comply with all laboratory safety procedures and guidelines.

Maintain a clean, organized, and safe working environment.

Manage laboratory waste in accordance with environmental regulations.

8.Continuous Improvement:

Identify opportunities for process improvements and efficiency enhancements within the QC laboratory.

Contribute to the revision and creation of Standard Operating Procedures (SOPs) and other quality documents.

9.Strategic Leadership & Management

• Establish Strategic Direction:Develop and execute the long-term strategy for the QC department, aligning it with the company's overall business and quality objectives.
• Team Leadership:Lead, mentor, and manage the QC team, fostering a culture of quality, compliance, and continuous improvement. Manage department budget, resources, and personnel development.
• Laboratory Oversight:Oversee the daily operations of the QC laboratory, including scheduling, resource allocation, and maintaining laboratory infrastructure, instrumentation, and environment.

10.Regulatory Compliance & Quality Systems

• Compliance Assurance:Ensure all QC testing, documentation, investigations, and releases comply with cGMP, GLP, Pharmacopoeial requirements (e.g., USP, EP, JP), and regulatory filings.
• Audit Management:Serve as the primary QC representative during regulatory inspections (e.g., FDA, MHRA, EMA) and internal/external audits. Ensure timely and effective closure of all QC-related audit observations and CAPAs.
• Documentation Control:Review and approve critical QC documentation, including Standard Operating Procedures (SOPs), test methods, specifications, method validation/transfer protocols and reports, and stability protocols.

11.Analytical Operations & Data Integrity

• Testing & Release:Direct the accurate and timely testing of all materials (Raw, In-Process, Finished Product, Stability) and authorize the release or rejection of products based on analytical results.
• Investigations:Oversee and approve all QC investigations, including Out-of-Specification (OOS), Out-of-Trend (OOT), and deviation reports, ensuring thorough root cause analysis and effective corrective and preventive actions (CAPA).
• Method Life Cycle Management:Direct the development, validation, transfer, and routine monitoring of analytical test methods to ensure they are phase-appropriate and robust.
• Data Integrity:Champion data integrity practices within the QC laboratory, ensuring all electronic and paper records are accurate, complete, and attributable.

12.Cross-functional Collaboration

• Internal Partnering:Collaborate closely with Manufacturing, Quality Assurance (QA), Regulatory Affairs, and Research & Development (R&D) to resolve quality issues, support process improvements, and meet production deadlines.
• Supplier Quality:Coordinate with QA to evaluate and monitor the quality of materials received from suppliers.

Qualifications:

Education:Bachelor's or Master's degree in Analytical Chemistry, Organic Chemistry

Experience:3-6 years of progressive experience in Quality Control within a pharmaceutical manufacturing environment.

Skills & Competencies:

Proficient in operating and troubleshooting a wide range of analytical instruments (HPLC, GC, UV-Vis, FTIR, KF, Dissolution apparatus, etc.).

Strong understanding of analytical method validation and transfer principles.

Experience with LIMS (Laboratory Information Management System) is highly desirable.

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

In-depth knowledge of cGMP, GLP, and regulatory requirements (e.g., ICH guidelines).

Excellent analytical, problem-solving, and critical thinking skills.

Strong attention to detail and accuracy.

Ability to work independently and as part of a team in a fast-paced environment.

Excellent written and verbal communication skills.

Strong organizational and time management skills.

Experience with specific pharmaceutical dosage forms (e.g., tablets, capsules, injectables, liquids).

Familiarity with Data Integrity principles.

Certification in Six Sigma or Lean Manufacturing is a plus.