Deputy Manager - QA Qualification & Compliance

Why This Role Matters
In sterile pharmaceutical manufacturing, Qualification and Validation are critical pillars of regulatory compliance, product quality, and patient safety. This leadership role directly supports the integrity of manufacturing systems, cleanrooms, utilities, equipment, and processes. Working in a USFDA and GMP-compliant environment, you will ensure that systems consistently operate within validated parameters, safeguarding both regulatory approvals and global market access.
This is an opportunity to contribute at a strategic level within a rapidly expanding sterile injectables facility. Your expertise will directly impact audit readiness, operational excellence, and compliance across regulated markets.

Job Description
Immaculé Lifesciences Pvt. Ltd. is seeking an experienced Assistant Manager / Deputy Manager – Qualification & Validation (Quality Assurance) for its state-of-the-art sterile manufacturing facility in Nalagarh, Himachal Pradesh. The role is ideal for a seasoned pharmaceutical professional with strong experience in equipment qualification, process validation, cleaning validation, and regulatory compliance within regulated manufacturing environments.
The selected candidate will oversee validation lifecycle activities, ensure documentation compliance, coordinate cross-functional teams, and maintain audit readiness in alignment with USFDA, WHO-GMP, and other international standards.

Key Features of the Role
• Leadership role within Quality Assurance – Validation
• Exposure to sterile injectables and lyophilized product manufacturing
• Work in a USFDA and GMP-compliant facility
• Cross-functional coordination with QA, QC, Engineering, and Production
• Strategic involvement in regulatory audits and inspections
• Opportunity to drive validation lifecycle improvements
• Competitive compensation aligned with senior-level experience
• Professional growth in a fast-expanding pharmaceutical organization

Responsibilities
• Oversee qualification of equipment, utilities, HVAC systems, cleanrooms, and water systems
• Review and approve IQ, OQ, PQ protocols and reports
• Manage process validation, cleaning validation, and revalidation activities
• Ensure compliance with current GMP, USFDA, and international regulatory guidelines
• Coordinate validation schedules with Engineering and Production departments
• Maintain validation master plans (VMP) and lifecycle documentation
• Support technology transfer and new product introduction activities
• Participate in regulatory audits and address audit observations
• Conduct risk assessments and implement CAPA for validation-related deviations
• Review change control documentation impacting validated systems
• Ensure timely closure of deviations related to qualification and validation
• Train and mentor junior QA/validation team members
• Drive continuous improvement initiatives in validation systems

Required Qualifications
• Bachelor's degree in Pharmacy (B.Pharm) (mandatory)
• 12 to 14 years of experience in pharmaceutical Quality Assurance
• Minimum 10+ years of hands-on experience in qualification and validation
• Experience in sterile injectables or regulated manufacturing preferred
• Strong knowledge of USFDA, WHO-GMP, and international regulatory standards

Educational Requirements
• Bachelor of Pharmacy (B.Pharm)
• Additional certifications in Validation, GMP, or Regulatory Affairs are advantageous

Experience and Skills
• In-depth understanding of validation lifecycle management
• Strong knowledge of sterile manufacturing practices
• Experience handling regulatory inspections and audits
• Excellent documentation and technical writing skills
• Strong leadership and cross-functional coordination abilities
• High attention to detail and compliance-driven mindset
• Proficiency in risk management and deviation handling
• Strong analytical and problem-solving capabilities

Salary Insights
• Assistant Manager/Deputy Manager level (10+ years): ₹10–18 LPA
• Performance-based incentives
• Health insurance coverage
• Provident Fund benefits
• Transport facilities (common in Nalagarh/Baddi industrial belt)
• Professional development opportunities within a regulated manufacturing environment

Company Overview
Immaculé Lifesciences Pvt. Ltd. is a growing pharmaceutical manufacturer specializing in sterile injectables and lyophilized products. Operating from its advanced facility in Nalagarh, Himachal Pradesh, the company focuses on quality-driven production for regulated international markets. With strong compliance systems and expansion plans, Immaculé provides a stable and growth-oriented environment for experienced pharmaceutical professionals.

FAQs

Q: Is sterile manufacturing experience mandatory?
A: Strongly preferred, especially for validation roles involving injectables and lyophilized products.

Q: Will the role involve audit interaction?
A: Yes, active participation in USFDA and other regulatory inspections is expected.

Q: Is relocation to Nalagarh required?
A: Yes, this is an on-site manufacturing role based in Nalagarh, Himachal Pradesh.

Q: What level of leadership is expected?
A: The role requires supervision of validation activities and mentoring junior team members.

Application Tips
• Clearly mention validation lifecycle experience (IQ/OQ/PQ) in your CV
• Highlight sterile injectables or regulated plant experience
• Include audit exposure (USFDA, WHO-GMP, etc.)
• Quantify major validation projects handled
• Mention leadership or team-handling responsibilities
• Demonstrate compliance mindset and documentation strength