AM/ DM Quality (Project Quality)

Senvion; Gujarat; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Senvion in Gujarat, India seeks a senior QA/QC and compliance leader to oversee organizational and programmatic elements of quality control, assurance and regulatory functions. You will plan resources, ensure timely submissions, validation, testing and release of products, maintain internal policies and standards, and collaborate with senior management on KPIs and CAPA processes.

The role involves liaison with external regulators, internal audits, CAPA management, and driving quality

Qualifications

• Extensive experience in quality control and QA processes.
• Familiarity with ISO standards and regulatory compliance.
• Strong capability to lead audits and CAPA programs.

Responsibilities

• Plan and organize personnel and workflow to ensure timely submissions, approvals, validations and releases.
• Ensure compliance with internal and external regulations and standards for quality and regulatory status.
• Develop, implement and monitor strategic quality plans and objectives.
• Provide updates to senior management on progress of quality objectives and cross-functional goals.
• Maintain contact with vendors and industry bodies to stay current with standards.
• Represent the company in interactions with external regulatory and standards bodies.
• Ensure internal audits and CAPA development/execution are timely and global.
• Oversee validation programming for manufacturing processes and methods.
• Ensure timely product releases in line with procedures and regulatory requirements.
• Oversee labs to operate safely under OHSAS requirements.
• Provide SME support to promote products and ensure supplier quality.

Skills

QA Leadership

Regulatory Compliance

CAPA Management

Quality Systems

Job description

Oversee organizational and programmatic elements of company's quality control, quality assurance and compliance functions.

• i. Plan and organize personnel and workflow utilization in order to implement the timely submission, approval, validation, testing and release of products and processes in accordance with the FAOP and internal quality system policies, procedures and external regulations and standards that govern the products manufactured, tested, stored, promoted and/or distributed by or for the company.
• ii. Ensure compliance with applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of company operations, processes and products.
• iii. Develop, implement and monitor progress against the company's strategic quality plan, related quality objectives, projects and goals for quality department.
• iv. Provide update and recommendation to the company senior management staff with regard to the status of such objectives, projects and goals as relate to cross-functional business objectives (MRM, MIS).
• v. Maintain contact with critical vendors, professional organizations, consultants and peers in order to be abreast with current with the prevailing industry standards.
• vi. Represent as the companys primary liaison regarding affairs involving interaction with external regulatory and standards bodies (ISO assessors) when necessary to adjudicate issues with product submissions, product performance, compliance concerns and prevailing/impending regulatory requirements.
• vii. Ensure internal audit program is adequately defined and followed (inclusive of comprehensive CAPA development, approval and execution) in a manner that is both timely and global in nature.
• viii. Ensure efficient and effective validation programming and execution for manufacturing processes, test methods, facilities/equipment/utilities by employment of a comprehensive validation master plan.
• ix. Ensure product is released in a timely manner in compliance with company procedures and regulatory requirements.
• x. Ensure that all quality related laboratories (both within company as well as those that perform contract testing for company) operate in an efficient and safe manner in accordance with OHSAS requirements.
• xi. Provide organizational and subject matter expertise to support in promotion of company's products
• xii. Counsel respective SQA for development in manufacturing and inspection processes, techniques, procedures or facilities/equipment in regards to ensuring compliance with applicable quality and regulatory criteria at the supplier front.
• xiii. Recommend actions or policies that result in cost reduction, efficiencies or increased profitability to the company.
• xiv. Ensure that critical or strategic priorities at the site and corporate levels are afforded resources and sufficient quality oversight to ensure timely resolution and complete without undue concern for delay non-conformance or non-compliance.
• xv. Define and approve departmental budget and capital expenditures.