Technical / Functional :

Job Objective :

To obtain a position as a Quality Control Reviewer where high sound of analytical skills, and experience in quality control processes and compliance in Quality Control.

Job Role:

• Shall be responsible forHandling of the QMS system in department.
• Shall be responsible for the conduct laboratory investigations and to find the appropriate root cause for the occurred event.
• Shall be responsible for CAPA implementations and effectiveness verification.
• Shall be responsible for the preparation of SOP’s , STPs and protocols originating from QC department.
• Collaborate with production teams, R&D, and other departments to address quality-related issues.
• Communicate quality-related concerns effectively to the relevant teams, ensuring swift resolution.

Desired attributes :

Technical / Functional

• Sound knowledge in QC processes, industry-specific standards and regulatory guidelines.
• Proficient in fluent English, Hindi and good communications and to be interact with U.S and other clients.
• Shall be responsible for the Review of analytical documents.
• Shall be responsible for conducting training programs to all QC employees.
• Sound knowledge in HPLC,GC and wet instrumentation.
• Proficiency in using QC tools and software.

Behavioral :

• Attention to detail and strong observational skills.
• Strong understanding of quality control principles and methodologies.
• Effective communication and teamwork skills.
• Problem-solving abilities and the ability to manage corrective actions.
• Patience and good time management.
• Willingness to learn and grow.

Undertaking any other duties which may be assigned as deemed appropriate by the organization

Technical / Functional :

Job Objective :

To perform the QA activities in view of system upgradation and improvement in the existing procedures.

Job Role:

• 1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events.
• 2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable.
• 3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the Inspectors /Auditors.
• 4. Preparation & review of quality risk assessment reports of products & general systems.
• 5. Conduct on the Job Training and cGMP trainings.
• 6. Implement documentation system to develop, maintain, distribute and control of all Quality Control, Quality Assurance, Production, Maintenance and Warehouse records.
• 7. Planning & execution of internal quality audits and perform vendor audits for the KSMs and packaging materials for vendor qualification.
• 8. Co-ordination with the customer for compliance and day to day issues.
• 9. Quality agreements review and preparation.

Desired attributes :

Technical / Functional :

• Should have exhaustive knowledge on the drafting skills (E.g. Investigations, Responses & compliance).
• Should have sound command on the English with speaking and Writing.
• Sound knowledge of the production operations, QC analytical techniques & facility and maintenance functions.

Behavioral :

Team management, Leadership, Project management, Proactive, Time management and Critical thinker.

Undertaking any other duties which may be assigned as deemed appropriate by the organization

Technical / Functional :

• To perform activities related to production and monitoring the process SOPs.
• To communicate day to day process deviations and breakdowns of the equipment to concerned persons.
• Check and implement the process for cleaning of equipment as per the schedules.
• Responsible for plant house keeping and implementation of day to day cleaning of process area.
• Responsible to identify and maintenance and electrical problems and inform to shift in change and raise work order to maintenance dept.
• Responsible to maintain better relations with helpers, motivate them to handle works accordingly to systems and procedures.
• Responsible to co-ordinate with QC department for in process samples results and recording in BPRs.
• Responsible to carry out the operations as per BPR and cleaning procedure as per BCR.
• Responsible to adhere all safety practices such as using safety items as and when it is essential to handle serve the chemicals.

Undertaking any other duties which may be assigned as deemed appropriate by the organization

Technical / Functional :

• Responsible for the calibration of all the instruments in instrumental laboratory and maintaining the calibration records as per sop frequencies.
• Responsible for preparing all volumetric solutions and standardization of the same.
• Responsible for preparing all bench reagents and maintaining the records.
• Responsible for the handling of HPLC & GC Instruments.
• Responsible for perform the calibration of HPLC & GC instruments.
• Responsible for perform the analysis of raw material, water, In-process, intermediate, finished product, packaging material.
• Responsible for sampling and analysis of all raw materials and packing materials.
• Responsible for checking packing conditions, labels and storage condition before doing the sampling and preparation of the sampler report.
• Responsible for method validation and the maintenance of the analytical instruments.
• Responsible for the literature survey for the development of analytical methods.
• Responsible for the analytical method developments and validations.
• Responsible for maintaining records for all the quality checks of raw materials, intermediates and finished product.
• Responsible to review and handover the executed documents in quality control to quality assurance

Undertaking any other duties which may be assigned as deemed appropriate by the organization