Job Description

Quality Management System (QMS):

Establish, implement, and maintain an effective Quality Management System as per WHO-GMP and Schedule M.

Review, approve, and control SOPs, STPs, specifications, formats, and records.

Ensure compliance with Data Integrity (ALCOA+) principles.

Documentation & Compliance:

Review and approve Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).

Ensure timely review of deviations, change controls, OOS, OOT, and CAPA.

Ensure proper document control and archival as per regulatory requirements.

Product Release & Validation:

Responsible for final batch release of finished products.

Oversee validation activities including process validation, cleaning validation, and equipment qualification.

Ensure stability studies are conducted and reviewed as per approved protocols.

Regulatory & Audit Management:

Prepare and support regulatory inspections (WHO, CDSCO, State FDA, ISO).

Handle internal, external, and customer audits.

Ensure timely closure of audit observations with effective CAPA.

Vendor & Material Quality:

Qualification and approval of vendors and contract manufacturers.

Review and approval of raw materials, packaging materials, and finished goods specifications.

Training & Team Management:

Conduct GMP and quality-related training for QA and production staff.

Lead, guide, and develop the QA team.

Ensure training records are maintained and updated.

Continuous Improvement:

Monitor quality trends and implement continuous improvement initiatives.

Ensure reduction of deviations, complaints, and rejections.

Qualifications:

Education: B.Pharm / M.Pharm / MSc (Chemistry or related discipline)

Experience: Minimum 8-12 years of experience in Pharmaceutical Quality Assurance

(At least 3-5 years in a managerial role preferred)

Skills & Competencies:

Strong knowledge of WHO-GMP, Schedule M, and regulatory guidelines

Excellent documentation and analytical skills

Audit handling and regulatory inspection exposure

Leadership and team management skills

Good communication and problem-solving abilities

Preferred Industry:

Pharmaceutical Formulations / API / Nutraceuticals (as applicable)

Key Performance Indicators (KPIs):

Audit compliance and successful regulatory inspections

Timely batch release

CAPA effectiveness

Reduction in deviations and quality issues

Job Types: Full-time, Permanent

Pay: ?25,000.00 - ?50,000.00 per month

Ability to commute/relocate:

Udham Singh Nagar, Uttarakhand: Reliably commute or willing to relocate with an employer-provided relocation package (Preferred)
Education:

Diploma (Preferred)
Experience:

Pharma industry: 5 years (Preferred)
Work Location: In person