Associate Manager

Job Description:

Responsibilities

• Strong knowledge of manufacturing processes, quality control, and validation activities (process, cleaning, analytical methods, equipment, utilities)
• Advanced technical document review and approval capability
• Expertise in change control and risk assessment
• Strong knowledge of chemical and microbiological testing
• Knowledge of investigations tools and root cause analysis methodologies
• Understanding of manufacturing operations, engineering, and validation systems
• Experience in handling regulatory inspections
• Accountability: Self-driven, proactive, and responsible for quality outcomes
• Critical thinking and strong compliance mindset
• Strong time management and problem-solving abilities
• Interpersonal Skills: Builds strong cross-functional relationships and communicates effectively across all organizational levels
• Decision Making: Makes timely, independent, and risk-based quality decisions
• Leadership Skills: Provides guidance, coaching, and technical direction to team members
• Core Responsibilities:
• Quality Operations
• Review and approve QC documents (BQ, CQ), batch records, validation protocols, and reports
• Review and approve SOPs, specifications, STPs, and study protocols
• Review stability reports, APRs, and trend reports
• Ensure manufacturing quality compliance and adherence to procedures
• Participate in Site Change Review Committee (SCRC) and assess critical changes
• Provide quality oversight for manufacturing and laboratory operations
• Quality Compliance
• Ensure implementation and effectiveness of Quality Management Systems (Change Control, CAPA, Deviations)
• Lead audit and inspection readiness activities (internal, regulatory, corporate)
• Interface with regulatory agencies and support inspections (USFDA, MHRA, etc.)
• Ensure compliance with cGMP, GDP, and global regulatory requirements
• Drive quality culture and continuous compliance improvements
• Review and approve quality system documentation and risk assessments
• Quality Investigations
• Lead, review, and approve deviation investigations and CAPA
• Ensure robust root cause analysis and effective corrective/preventive actions
• Drive timely closure of investigations and escalation of critical issues
• Utilize advanced investigation tools and methodologies
• Ensure investigation quality meets regulatory expectations
• Leadership & General Responsibilities
• Provide technical guidance and mentoring to junior team members
• Coordinate with cross-functional teams for resolution of quality issues
• Present critical quality decisions to leadership
• Identify process improvement opportunities and drive efficiency initiatives
• Ensure timely closure of action items and commitments
• Report and escalate critical non-compliance issues

Qualification & Experience

• B. Pharm/M. Pharm/M.Sc.
• Master’s Degree: 4 – 5 years
• Bachelor’s Degree: 6 – 8 years of experience in Pharma / Biotech Quality Assurance / Quality Control / Compliance / Investigations of sterile dosage manufacturing facility
• Change Management process
• Risk assessments principles and tools
• Validation of lab equipment’s
• Drug Product Process validations
• Regulatory requirements
• Compendial Changes
• Knowledge on Regulatory Guidelines, Good documentation practices and good manufacturing practices.
• Adhering to Site Procedures and corporate polices