Manager / Sr. Manager - Quality Control

Job Title:  Manager / Sr. Manager, Quality Control.

Qualification: Post Graduate in Science (Organic or Analytical Chemistry ) with 12 to 15 years of experience.

Job Summary:

Plan and implement Quality Control activity adhering to Zentiva Quality Guidelines, local FDA regulations, and HSE guidelines, leading a team of subordinates with optimum utilization of resources in order to ensure consistent good quality of products to meet with the GMP standards and customers’ requirements, living the Group’s Values and Code of Ethics. Strong leadership

• Analytical ability
• Interpreting skills
• Leadership
• Knowledge of cGLP & Regulatory Guidelines
• Modern QC instrumentation Techniques
• Communication
• Interpersonal Relationship Excellent problem-solving, decision-making, and organizational skills.

KEY ACCOUNTABILITIES

Quality

• Design & Implementation of cGLP for Pharmaceutical laboratory ensuring compliance with Global Quality guidelines, local FDA (Schedule M & L) and other regulatory requirements of importing countries and Zentiva Quality standard.
• Ensure analytical method validation and transfer. Responsible for review and approval of SOPs, recording formats, test methods - specification, validation protocol / report, qualification and calibration of record of laboratory equipment, OOS/OOT/deviation investigation and re-analysis/fresh analysis decision, management of reference standards, Retained sample Management and training on GLP.
• Ensure the maintenance of laboratory premises and equipment.
• Manage Pharmaceutical laboratory activities by organizing / planning of sampling, testing, Qualification, Validation, Calibration, maintenance and related documentation.
• Participate in failure investigation, to carry out root cause analysis of failure /market complaints if any. Maintain change control, deviation & CAPA system.
• Responsible for reviewing the testing raw data, log book and related documents.

Testing

• Organize and ensure timely sampling and testing of Chemical, Microbiological and Physical analysis of RM/PM, intermediates, finished goods and other samples for Pharmaceuticals.  Also ensure timely analysis of stability samples, market complaints, process validation, cleaning validation and environmental monitoring samples.
• Ensure the monitoring of the stability of the products & stability section.
• Approval / Rejection of Raw Materials, Packaging Components and in process material.
• Extend testing support for Microbial testing & stability sample management of API / PD products / intermediates.
• Out Of Specification/ Out Of Trend Results investigations.
• Organize trending of QC analytical data as a part of Statistical Quality Control.
• To approve and monitor any contract laboratory.
• Organizing calibration / maintenance / qualification of laboratory Equipment and laboratory area.
• Organize collection and storage of Retention samples.

HSE  / IMS / GMP / GLP

• Implement the HSE and GMP norms, adherence to compliance, training and corrective actions in order to ensure that there is no deviation from the Zentiva standards and statutory HSE and GMP / GLP norms.
• Implement the system of working established as per IMS / ISO requirements in the Quality Operations department.
• Organizing and maintaining the health, safety and environmental management system.
• Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
• Reviewing pharmacopeias and change control evaluation.

Compliance

• Ensure compliance with FDA regulations; interact with local and State FDA authorities for Pharmaceuticals function requirements.
• Performing internal quality audit as well as third party GMP audit as a “Qualified Auditor” during Quality Audit abiding the audit schedule.

Training, People Management, and Industrial Relations

• Train team members for laboratory-related jobs and evaluate for individual development.
• Monitoring good industrial relations in the department.

Coordination

• Coordinate with purchase, warehouse, and production for planning and for vendor evaluation & development, for Technical Agreement Evaluation, Supplier Testing Approval, Audits of supplier- Contract Labs. Preparation and submission of laboratory documents for registration, for technical and liaison support respectively.

Other

• Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
• Organizing and planning requirements for laboratory consumables and monitoring the stock of chemical, glassware, standards, and other related items.