DALAS BIOTECH LIMITED

(JD)

Designation: Assistant Manager Quality Control (QC)

Department: Quality Control

Location: Bhiwadi, Rajasthan

Industry: API Biotech Manufacturing

Reporting To: Quality Control Manager / Head Quality

1. Job Purpose To manage and supervise Quality Control activities, ensuring that raw materials, in-process materials, finished products and laboratory operations comply with approved specifications, applicable GMP requirements and company quality standards.

2. Key Responsibilities

A. Quality Control & Laboratory Management

- Supervise day-to-day Quality Control laboratory activities.
- Ensure testing of raw materials, packing materials, in-process samples and finished products as per approved specifications.
- Review and verify analytical test results before approval.
- Ensure proper handling, calibration and maintenance of laboratory instruments such as HPLC, UV-Visible Spectrophotometer, pH Meter and other analytical equipment.
- Monitor laboratory performance and ensure timely completion of testing activities.

B. Documentation & GMP Compliance

- Ensure compliance with applicable GMP requirements, approved SOPs and internal quality procedures.
- Maintain proper documentation, data integrity and traceability of QC activities.
- Ensure readiness for internal, customer and regulatory audits.
- Support the preparation and implementation of corrective and preventive actions (CAPA).

C. Investigation & Quality Assurance Support

- Investigate Out of Specification (OOS) and Out of Trend (OOT) results.
- Support deviation investigations, root cause analysis and CAPA implementation.
- Coordinate with Quality Assurance, Production, Engineering and other departments to resolve quality-related issues.
- Ensure proper control and documentation of laboratory incidents and non-conformities.

D. Team Management

- Supervise QC chemists,



analysts and laboratory staff.
- Allocate daily testing activities and monitor work completion.
- Provide technical guidance and on-the-job training to team members.
- Monitor team performance, discipline and adherence to safety procedures.

E. Equipment & Inventory Management

- Ensure calibration, qualification and preventive maintenance of QC laboratory instruments.
- Monitor availability of laboratory chemicals, reagents, reference standards and consumables.
- Ensure proper storage, labelling and expiry monitoring of laboratory materials.
- Maintain laboratory housekeeping and safety standards.

3. Educational Qualification

- B.Sc., M.Sc. Chemistry / Analytical Chemistry or B. Pharm / M. Pharm.
- Relevant pharmaceutical Quality Control laboratory experience is preferred.

4. Experience

- Approximately 512 years of experience in pharmaceutical Quality Control.
- Relevant experience in a supervisory or team-handling role is preferred.
- Experience in HPLC, UV spectroscopy, analytical testing and GMP documentation is desirable.

5. Required Skills

- Robust knowledge of pharmaceutical QC laboratory operations.
- Practical knowledge of HPLC and UV-Visible Spectrophotometer.
- Understanding of GMP, GLP, SOPs, OOS/OOT, deviations and CAPA.
- Analytical thinking, problem-solving and decision-making skills.
- Team management, communication and documentation skills.

6. Key Performance Indicators (KPIs)

- Timely completion of QC testing and release-related activities.
- Accuracy and reliability of analytical results.
- Compliance with GMP and approved SOPs.
- Reduction in documentation errors and repeat deviations.
- Timely closure of investigations and CAPA.
- Calibration and maintenance compliance for laboratory instruments.
- Successful completion of internal and external audits.

Contact on:- Mail ID:- [email protected] Mobail No. (phone hidden)

📌 Assistant Qc Manager (Bhiwadi)
🏢 DALAS BIOTECH
📍 Bhiwadi