Quality Assurance Executive

Tintess S.p.A.; New Delhi; On-site; INR 1,500,000 - 2,400,000; Full time

Job summary

Tintess S.p.A. seeks a qualified Quality Assurance/Regulatory professional to oversee all QC operations in the laboratory unit and ensure compliance with Indian CDSCO, FDA, and ISO standards.

The role involves leading internal and external audits, implementing CAPAs, and developing robust QMS procedures. A graduate degree in QA/regulatory and 5–6 years of experience are preferred. Strong leadership and documentation skills are essential.

Qualifications

• Graduate degree in a related field or equivalent experience.
• 5-6 years of experience in Quality Assurance/regulatory roles.
• Strong knowledge of CDSCO, ISO 9001, FDA requirements and quality systems.

Responsibilities

• Oversee and manage quality control operations in the laboratory unit.
• Ensure regulatory compliance with India CDSCO, Pharmacopeia, FDA regulations and ISO standards.
• Lead internal audits of Quality System and supplier audits.
• Coordinate CAPA, change control, and corrective actions.
• Develop and maintain QMS procedures, training, and records.
• Supervise Quality Control Manager and Quality Control Inspector positions.

Skills

Advanced communication

MS Office

Analytical thinking

Auditing

Change management

Regulatory knowledge

Education

Graduate degree in QA/Regulatory

Tools

MS Office

QMS software

Job description

Main Purpose

The main purpose of this position is to responsible for overseeing and managing all aspects of quality control operations within the laboratory unit. The primary goal of this role is to ensure that all laboratory activities, processes, and products meet the highest standards of quality, safety,and compliance with industry regulations. This role involves overseeing testing, inspection,

auditing, and the implementation of corrective actions to ensure that quality benchmarks are consistently met.

Main Duties

Regulatory Affairs Ensure regulatory compliance India CDSCO / Pharmacopeia, FDA regulations / ISO 9000 and others as applicable

Quality Systems. Perform internal audits of Quality System according to Indian and US FDA's Quality System Requirements, ISO 9001 or any other quality standard deemed

necessary.

• Participate in external audits, including supplier audits, customer audits and inspections by Indian and FDA's agencies and ISO Notifying Body.
• Conducting periodical evaluation of Suppliers and supplier development. Prepare documents and data for different Supplier/ contractor for audits as needed
• Submit reports from internal and external audits to appropriate personnel and initiate audit follow up actions, to include Corrective and Preventive Actions where applicable.
• Provide support in development of QMS procedures, instructions and forms while ensuring continuous improvement of quality management system. Participate in implementing CAPA actions where needed
• Manage and maintain all aspects of the Quality System, including Change Control; CAPA; Customer Complaints and Compliance
• File complaints to vendors; initiate corrective action requests; assess suppliers' CAPA reports; participate in suppliers' auditing and qualification process.

Quality/Regulatory General

• Perform function of Official Correspondent in front of the FDA and other government authorities.
• Review and draft new business Quality Agreements.
• Supervise, coach, and develop all quality employees.
• Mentor, train, and recommend qualified employees for advancement.
• Perform the responsibilities of Quality Control Manager during his/her absence.
• Adhere to safety and security policies; participate in safety and security training and improvement projects
• Report unsafe or unhealthy conditions and assist with emergency or investigative situations related to areas of responsibility

Quality Assurance

• Maintain all controlled document files and test records in a timely and accurate manner.
• Maintain updated matrix of records; maintain backup copies of required records and archive.
• Participate in the qualification of packing processes and software validation as required.
• Coordinate associated training activities for the company: develop training matrix for every position and annual/semi-annual training plans, initiate training requests, perform trainings, and maintain training records
• Develop comprehensive Quality and Regulatory training programs for all employees.
• Make written procedures for identification, documentation, appropriate review and approval of RM, specifications, analytical methods, facilities, support systems, equipment, processing steps, labeling and packaging materials and computer software.
• Written procedures shall be established assigning responsibility for sanitation and describing the cleaning schedules, methods, equipment, and materials to be used in cleaning buildings and facilities
• Ensures written procedures for all activities carried out, are established and followed
• Ensures personnel shall practice good sanitation and health habits appropriate measures shall be established and implemented to prevent cross-contamination from personnel and materials moving from one dedicated area to another
• Ensures there are written procedures describing in detail the receipt, identification, storage, handling, sampling, testing and approval or rejection of raw material containers and closures and these procedures are followed
• Reviewing completed laboratory control records of critical process steps before release of the material.
• Reviewing and approving validation protocols and reports
• Ensuring data protection shall be established for all computerized systems
• Check records of different departments as needed for audits
• Validation of general, cleaning, analytical methods, in-process control, test procedures, computerized systems and persons responsible for design, review, approval and documentation of each validation phase
• Approving changes that potentially affect the product quality and performing below product quality reviews
• A review of all lot of raw materials failed to meet established specification(s)
• A review of all critical deviations or non-conformances and related investigations
• A review of results of the stability monitoring program
• A review of all quality-related returns, complaints and recalls
• A review of adequacy of corrective actions
• Evaluate and assess the results of the above reviews and decide whether corrective or any revalidation shall be undertaken. Documents the reasons for such corrective action and ensures agreed corrective actions is completed in a timely and effective manner
• Ensures that training shall be regularly conducted by qualified individuals and shall cover, at a minimum, the particular operations that the employee performs and as applicable to the employee's functions.
• Ensures records of all the trainings are maintained and periodically assessed
• Investigate the discrepancies established during reconciliation of labels issued, used and returned
• Ensures raw material containers and closures shall at all times be handled and stored in a manner to prevent contamination
• Verifies each container or grouping of containers for raw material or each lot of raw material shall be appropriately identified as to its status(i.e., quarantined, approved, or rejected)
• Ensures each lot of raw material shall be withheld from use/export until the lot has been sampled, tested, or examined, as appropriate, and released for use/export by QC.

Supervisory Responsibilities

This position directly supervises the Quality Control Manager and Quality Control Inspector Positions.

Work Environment

This job operates primarily in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Some responsibilities require the employee to operate in a warehouse/ production environment using standard warehouse equipment such as forklifts, hand trucks, box cutters and tape

dispensers.

Physical Demands

This is largely a desk-based role; however, some filing and other physical ability is required. This would require the ability to lift files, open filing cabinets and bend, stoop, or stand as necessary. This role also works with large machinery and electronics and requires appropriate safety equipment and practices when necessary. While performing the duties of this job, the employee is regularly required to use hands to finger, handle or feel; reach with hands and arms; and talk or hear. The employee frequently is required to stand; walk; and stoop, kneel, crouch or crawl. The employee is occasionally required to sit and climb or balance. The employee must regularly lift

and/or move objects up to 10 pounds, frequently lift and/or move objects up to 50 pounds, and occasionally lift and/or move objects that weigh more than 100 pounds utilizing forklift or pallet jack. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Knowledge, Skills and Abilities

Advanced communication skills.

Advanced multi-tasking and organization skills.

Advanced change management skills.

Ability to create and maintain highest levels of confidentiality when dealing with proprietary information and sensitive situations.

Intermediate to advanced math skills.

Ability to define problems, collect data, establish facts, and draw valid conclusions.

Intermediate to advanced knowledge of MS Office (Particularly Word and Excel).

Six Sigma and/or other quality, continuous improvement, technical writing, regulatory

knowledge.

Working knowledge of standard measuring tools and machinery.

Expert knowledge of CDSCO, ISO, FDA, and other regulatory/ quality entities that impact areas of responsibility

Education / Experience

Graduate degree in a related field or equivalent experience and

5-6 years of experience in the Quality Assurance field

Core Competencies:

Advanced business acumen

Proficiency with MS Office basic software (Outlook, Word, Excel, PowerPoint)

Advanced communication

Advanced knowledge conducting internal and external audits

Familiarity with technical documentation

Advanced knowledge of CDSCO, ISO 9001 and 21 CFR 210 & 211, and other quality/regulatory requirements

Change Control Management

Change Management

Autonomy in daily activities

Six Sigma Continuous Improvement, 5S, and/or other similar quality disciplines.

Other Duties

Other duties as may be assigned from time to time.