Tulip Lab Pvt. Ltd Walk-in 18th to 21st March for QA,QC

Job Summary:

The Manager Quality Assurance will be responsible for overseeing QA, QC, and Microbiology functions to ensure compliance with regulatory requirements, cGMP standards and company quality systems. The role involves managing documentation, validation activities, audits, quality investigations and coordinating with cross-functional departments to maintain product quality and regulatory compliance.

Role & responsibilities:

Department Leadership

• Lead and manage QA, QC, and Microbiology departments on a daily basis.
• Ensure all departments operate in compliance with regulatory requirements and industry standards.
• Drive continuous improvement initiatives and implement process modifications where required.
• Coordinate with Production, Stores, Engineering, and HR to ensure smooth day-to-day operations and avoid delays.

Regulatory Compliance & Audits

• Ensure compliance with regulatory requirements and current industry standards (cGMP/GLP).
• Prepare and coordinate client audits and regulatory inspections.
• Ensure readiness for audits and timely closure of audit observations.
• Fulfil all regulatory documentation and compliance requirements.

Quality Assurance Responsibilities

• Monitor and ensure effective implementation of Quality Management System (QMS).
• Oversee change control, deviation management, incident investigation, and QC incidents.
• Identify quality issues and implement Corrective and Preventive Actions (CAPA).
• Ensure training and competency development of QA/QC/Micro personnel.
• Monitor Annual Product Quality Review (APQR) activities.
• Oversee Cleaning Validation and Process Validation programs.

Quality Control Responsibilities

• Ensure proper testing and inspection of raw materials, in-process samples, and finished products.
• Supervise analytical testing and laboratory operations.
• Investigate Out-of-Specification (OOS), deviations, and laboratory incidents.
• Oversee stability studies and shelf-life determination of products.

Microbiology Department Responsibilities

• Oversee microbiological testing and analysis of products.
• Ensure microbiological testing for Oral Solid Dosage (OSD) formulations.
• Monitor environmental monitoring programs and contamination control.
• Investigate microbial contamination incidents and implement corrective actions.

Preferred candidate profile:

• Strong knowledge of cGMP, GLP, and regulatory guidelines.
• Experience handling regulatory and client audits.
• Expertise in QMS, validation, and quality investigations.
• Strong leadership and cross-functional coordination skills.
• Good analytical, documentation, and problem-solving abilities.

Quality Control-Executive & Officer

Candidates Job Summary:

The QC Executive / Officer will be responsible for performing analytical testing of raw materials, packaging materials, in-process samples, finished products, and stability samples using various analytical instruments. The role includes maintaining compliance with GMP standards and ensuring accurate documentation and calibration of laboratory equipment.

Role & responsibilities:

Instrument Handling

• Operate and handle analytical instruments such as HPLC (Empower 3.0 / Chromeleon 7.3 software).
• Perform analysis using Dissolution Tester, HPTLC, IR, UVVIS Spectrophotometer, pH Meter, KF Titrator, and Auto Titrator.

Sample Analysis

• Perform analysis of Raw Materials (RM), Packaging Materials (PM), Finished Products (FP), Validation Samples, and Stability Samples.
• Ensure testing is conducted as per approved specifications and standard test procedures.

Calibration & Maintenance

• Carry out calibration of laboratory equipment and analytical instruments as per defined schedules.
• Maintain proper documentation for instrument calibration and maintenance records.

Documentation & Compliance

• Maintain analytical records as per GMP and GLP requirements.
• Ensure proper documentation of test results and analytical reports.

Key Skills:

• Strong knowledge of analytical testing techniques.
• Hands-on experience with HPLC and laboratory analytical instruments.
• Knowledge of GMP/GLP practices and laboratory documentation.
• Good analytical and problem-solving skills.

Additional Requirements:

• Candidate should be ready to relocate if required.
• Immediate joiners will be preferred.

Preferred candidate profile:

Immediate Joiner Preferred

M.Sc. in Analytical Chemistry / Organic Chemistry from a reputed university.

Interested candidates can share the CV at prashant.b@tuliplab.com