Dishman Carbogen Amcis

3 weeks ago

Ahmedabad, Gujarat, India DISHMAN CARBOGEN AMCIS LIMITED Full time

Position Summary:

Dishman Carbogen Amcis Limited is seeking an experienced and proactive Manager - Formulation QC to oversee and manage day-to-day Quality Control operations for the formulation unit. This role is critical to ensuring compliance with GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices), supporting the company's quality standards and regulatory requirements. The candidate will also be responsible for QMS (Quality Management System) investigations, trend analysis, and leading a team of QC professionals.

Key Responsibilities:

Laboratory Operations:

- Manage and supervise all day-to-day activities in the Formulation QC Laboratory, ensuring adherence to testing schedules and timelines.

- Ensure compliance with GLP, GMP, and internal quality standards during all analytical and documentation activities.

- Oversee sampling, testing, and release of raw materials, packaging materials, in-process samples, finished products, and stability samples.

- Review and approve analytical results, test protocols, and validation reports.

Documentation & Compliance:

- Ensure accurate documentation and maintenance of laboratory records, logbooks, and electronic systems.

- Review and ensure compliance of all laboratory documentation as per regulatory requirements.

- Prepare and review SOPs related to laboratory operations and ensure periodic training of staff.

Quality Management System:

- Investigate and close QMS-related activities, including deviations, out-of-specifications (OOS), out-of-trend (OOT) results, laboratory incidents, and CAPAs.

- Participate in internal and external audits, regulatory inspections, and implement corrective actions.

- Maintain the laboratory in an inspection-ready state at all times.

Trend Analysis & Reporting:

- Monitor and analyze quality trends across batches and stability studies.

- Prepare periodic trend reports (e.g., stability trends, product quality reviews) and present to senior management.

- Identify areas of risk and recommend process improvements to enhance lab performance and compliance.

Team Leadership & Training:

- Lead, train, and mentor a team of QC analysts and junior staff.

- Ensure continual development of team skills and knowledge through structured training programs.

- Promote a culture of continuous improvement, accountability, and quality excellence within the lab.

Qualifications & Experience:

- Bachelor's or Master's degree in Pharmacy, Chemistry, or related field.

- Minimum 7-10 years of experience in a Quality Control role within a pharmaceutical formulation environment, with at least 2-3 years in a managerial capacity.

- In-depth understanding of GLP, GMP, and regulatory guidelines (e.g., USFDA, MHRA, WHO, etc.).

(ref:iimjobs.com)

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