Manager, QA Validation

Department: QA Validation

Location: Monroe, NC

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Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules - both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.

Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil.

Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research-based pharmaceutical company.

POSITION SUMMARY :

The Manager, QA Validation is responsible for providing leadership and strategic direction to the establishment of the validation/qualification programs (including the Qualification/PM/Calibration of instruments, equipment, and facilities) ensuring alignment with corporate standards and regulatory guidance. This position will be responsible for ensuring successful implementation of validation standards as they apply to facilities, utilities, equipment, computer systems, cleaning and processes. Additionally, person in this role is responsible for the support of facility start-up activities, technical transfers, requalification-s and routine activities as they pertain to Laboratories, Manufacturing, Maintenance and Warehouse functions.

Responsibilities:

• Preparation of Revenue and Capex Budget. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site

• Maintain quality system controls to ensure no critical and major market complaints

• Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency.

• Manage the validation system from a Quality Assurance perspective to ensure quality and compliance requirements are met in an efficient and effective manner, and in support of corporate objectives

• Act as the quality / validation SME for Change Controls supporting GMP/GLP systems.

• Ensure required Standard Operating Procedures and systems are implemented to support internal and external validation programs.

• Quality oversight and approval of software, equipment/facility qualification, IQ/OQ/PQ protocols and reports and associated change control systems.

• Ensure Site Validation Master Plan and CSVMP are followed at site level.

• Quality oversight and approval of internal and external process characterization project plans, protocols and report.

• Report validation/qualification quality issues and trends to management.

• Provide leadership and guidance to staff on qualification/validation issues.

• Review of executed calibrations and preventive maintenance (PM) plans in addition to review of calibration/PM program updates.

• Review and revise SOPs for consistency and compliance with regulatory requirements

• Providing oversight to analytical labs for instrument qualifications.

• Providing training to team personnel and managing to meet goals established

• Support regulatory inspections by FDA and foreign regulatory agencies

• Participates in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit and stakeholder feedback, and corrective/preventative actions.

• Participate in cross-functional risk assessments and process parameter classification

• Provide hands-on review and subject matter expertise of Validation lifecycle documentation including Process Design Documents, Process Control Strategy, Master Plans, Protocols and Reports

• Provide quality oversight and support for process, cleaning, shipping, computer system, equipment and instrument qualification and validation activities

• Participate on interdepartmental project / program teams to meet company / site milestones and objectives

• Stay abreast of industry and affiliated publications, memberships, and technologies to ensure organizational goals are met. Actively seek out new, cutting edge technology to further Quality Operations initiatives and build efficiencies

• Ensure compliance with current U.S. and EU cGMP regulations and industry standards

• Apply risk based methodologies in the oversight of validation efforts and CSV activities

Education :

A minimum of a Bachelor-s degree in Science or Engineering or associated fields is required

Experience :

• A 6-10 years of experience in Quality Assurance or Design Assurance in the Pharmaceutical, Biotech, medical device industry (or related industry), or experience in related engineering areas, e.g. R&D or Manufacturing

• Advanced degrees may be used to reduce required experience

Knowledge and Skills :

• Extensive knowledge of quality tools:

• CGMP

• Validations and Qualifications

• Regulatory guidelines

• US Pharmacopoeias

• Internal auditing

• Handling of regulatory Inspections

• Well acquainted with QMS and CSV

• Well versed with Change control/deviations and market compliant management system.

• Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (QDP); and ICH Q8, Q8, and Q10 procedures

• Proficiency with Microsoft Word, Microsoft Excel, and Power Point is required. Strong documentation skills are required.

• Experience with comparative Statistical techniques, sampling plans, GR&R, hypothesis testing, ANOVA, parametric and non-parametric analysis are also desired.

• The ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required.

• This candidate must be a technical expert and have excellent written and oral communication and interpersonal relationship skills.

• Certified Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE) strongly desired

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