Sr. Manager / Assistant General Manager Quality Assurance - Boisar

USFDA API Pharma Company

Education:

- Masters or Bachelors degree in Pharmacy or Science

(M.Sc. / B.Pharm / M.Pharm preferred)

- Certification in Regulatory Affairs can be added qualification
- Certification in Quality Management Systems (QMS) can add value to candidature

Experience:

- Total Experience: 20 to25 years in the pharmaceutical industry
- API Experience: 15 to 20 years (mandatory)
- Leadership Experience: 715 years in senior QA roles
- Proven experience in independently handling:
- USFDA inspections (minimum 3 successful inspections)
- MHRA / EDQM inspections
- Multiple global regulatory and customer audits

Role & responsibilities

Regulatory Exposure (Critical Requirement)

Must have hands-on experience with:

- USFDA inspections
- European regulatory agencies (EMA)
- WHO GMP audits
- MHRA, TGA, and PMDA inspections

Should demonstrate:

- Successful handling of at least three USFDA inspections
- Strong experience in 483 observation response management
- Leadership in regulatory strategy and compliance enhancement initiatives

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Technical Competencies (Core QA Skills)

Regulatory & Compliance Knowledge

- ICH Guidelines: Q7, Q8, Q9, Q10
- cGMP regulations (21 CFR Part 210/211)
- Understanding of DMFs and CEP dossiers

Core QA Expertise

- Cross functional procedural awareness of QC, Production, Warehouse, Engineering, etc.
- Change Control Management
- Deviation Management
- CAPA (Corrective and Preventive Actions) effectiveness
- Quality Risk Management (QRM)
- Documentation and compliance systems
- Data Integrity (ALCOA+ principles)




- SOP lifecycle management
- Audit trail review
- Trainings
- Vendor qualification
- Understanding of GMP software like QMS, LIMS, DMS, etc.

Validation Oversight

- Process validation
- Cleaning validation
- Analytical method validation
- Qualifications

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Leadership & Management Skills

- Experience in managing large QA teams (15 - 20 personnel)
- Strong cross-functional collaboration:
- QC, Production (PD), Regulatory Affairs (RA), Engineering, Warehouse
- Effective decision-making under regulatory pressure
- Ability to build and sustain a quality-driven culture
- Crisis management capability:
- OOS (Out of Specification)
- Data Integrity issues

Inspection Readiness & Audit Capability

- Lead internal and external audits
- Conduct mock audits and readiness programs
- Perform gap assessments and remediation planning
- Vendor qualification and auditing experience
- Maintain an “always inspection-ready” environment
- Strong audit defence skills

Data Integrity & Compliance Focus (Highly Critical for regulatory environment of USFDA, EUGMP, etc)

- In-depth knowledge of:
- Electronic systems: HPLC, GC, ERP, LIMS
- Audit trails and access controls
- Expertise in:
- Data integrity investigations
- Identification and mitigation of DI risks

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Behavioural Competencies

- High Ethical Standards & Integrity Demonstrates uncompromising commitment to ethics, compliance, and quality; acts as a role model for organizational values.
- Assertiveness with Diplomacy Ability to take firm, compliance-driven decisions while maintaining professional relationships with internal teams and external stakeholders.
- Robust Communication Skills (Global Interface) Excellent verbal and written communication with the ability to confidently interact with:
- Global clients
- Regulatory auditors (USFDA, MHRA, etc.)
- Senior leadership teams
- Ownership & Accountability Takes end-to-end responsibility for quality systems, regulatory outcomes, and business impact; drives closure with a results-oriented approach.
- Team building and leadership

Effective team building skills by being a team player. Motivate and educating the team members

Preferred candidate profile

- Total Experience: 20–25 years in the pharmaceutical industry
- API Experience: 15–20 years (mandatory)
- Leadership Experience: 7–15 years in senior QA roles
- Proven experience in independently handling:
- USFDA inspections
- MHRA / EDQM inspections
- Multiple global regulatory and customer audits

Perks and benefits

PF+ Gratuity+ Medical Insurance+ Annual Increment

If interested, pls share resume on [email protected]

Job Types: Full-time, Permanent

Pay: ₹900,000.00 - ₹2,000,000.00 per year

Benefits:

- Health insurance
- Life insurance
- Paid sick time
- Provident Fund

Work Location: In person

📌 Sr. Manager / Asst. General Manager - QA - Boisar (Palghar)
🏢 Ecolux Enterprises
📍 Palghar