Quality Manager/ Sr. Manager

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Evolet Pharmaceuticals is seeking a skilled Manager/Sr. Manager-Quality to oversee all aspects of quality assurance and control at our Roorkee manufacturing plant. The ideal candidate will have extensive experience in pharmaceutical quality management, ensuring compliance with regulatory standards and company objectives.

JOB DESCRIPTION

Job Title: Manager/ Sr. Manager - Quality

Location: Roorkee, Uttarakhand

Responsibilities:

• As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
• Primarily responsible for monitoring of work planning and fully responsible for supervising all quality assurance and quality control functions including but not limited to QA decision, QC decisions and compliance therein, related to developing and manufacturing of the product.
• Ensure that all activities in plant are carried out as defined in current good manufacturing practice norms.
• To guide the quality team and to provide the training related to current good manufacturing practice, current good laboratory practice.
• Leads, develops, and executes on the local quality strategy, ensuring alignment to the global vision and strategy and defining quality objectives in line with overall Contract Manufacturing quality objectives.
• To ensure timely approval or rejection of all in process product specification, raw material specification, packaging material specification, and standard testing procedure in consultation with QC department.
• To ensure timely review and approval of executed batch record for Export and Domestic market products.
• To ensure timely approval or rejection of any lot of raw materials, component, drug products.
• To monitor the retesting of raw material and packing material as per SOP.
• Review/ Approval of qualification documents of instrument/ equipment/ utility.
• Review/ approval of cleaning method, process validation and method validation document.
• Review and approval of SOPs of all departments, master documents related to QA, QC, production, warehouse, purchase, HR.
• Handling and investigation of market compliant/ customer notification.
• Conduct self-inspection as per schedule, participate in preparation and facing of internal and external audits.
• Coordinate with head QA for day-to-day activities related to IPQA, QMS, and Calibration & Validation.
• Review and approval of stability study protocol.
• Handling of narcotic and psychotropic substance related activities.
• Training to all department personnel related to quality systems, data integrity, compliance etc.
• To assist in preparation, checking, maintaining and updating documents as per current good manufacturing practice norms.
• To ensure that staff maintain proper discipline and carry out their work plan as per set standard and procedure.
• Responsible for coordinating with customers for quality/ compliance related activities.
• Leads regulatory agency interaction related to compliance to local and regional guidelines/ regulations and develops strong internal and external relationships with regulatory bodies and authorities
• Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
• Responsible and accountable for quality departmental budget
• As the management representative, ensures the quality system is implemented and its integrity maintained
• Direct and leads the facility readiness for all third party audits including notified bodies.
• Leads alignment and standardization of best practices and enterprise excellence across all sites producing Customer or owned platform devices.
• Play a role as a key contributor to Global Enterprise Quality documentation updating, including where appropriate, leading any updates
• Inspires innovation and quality excellence ensuring this culture is deeply engrained and sustained in the organization DNA
• Leads by example and sets the highest standards in employee engagement and communication.

Requirements:

• Bachelors Degree in either pharmacy, chemistry, biology or equivalent.(B.Pharma /M. Pharma/MBA.)
• Significant experience (15+ years) in pharmaceutical manufacturing, quality assurance, regulatory affairs, or a related field.
• A strong background in pharmaceutical quality management, having worked with at least two reputed companies for a significant tenure.
• Extensive experience in handling international regulatory audits as well as major Indian MNC audits.
• Expertise in quality systems, process validation, compliance, and regulatory affairs within a manufacturing environment.
• English communication verbal and written skills
• Strong proficiency in computer applications, including MS Office (Excel, Word, PowerPoint) and other relevant software used for quality management and regulatory documentation.
• Proven track record of implementing process improvements and ensuring compliance with regulatory standards.

Preferred Knowledge, Skills and Abilities:

• Regulatory Skills: In-depth knowledge of pharmaceutical regulations and guidelines, including cGMP, ICH guidelines, and other relevant regulatory requirements.
• Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
• Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
• Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
• Ethical Standards: Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
• Self-motivated with a proactive attitude and the ability to work effectively.

Interested are welcome to share their resumes at vacancy@evolet.in