26 Aug
|
Systacare Remedies
|
Bal Kalan
26 Aug
Systacare Remedies
Bal Kalan
Job Description - Department Head (Microbiology Head)
Company: Systacare Remedies
Position: Department Head - Microbiology
Location: Balkalan, Amritsar
Department: Quality Control - Microbiology
Employment Type: Full-time
Job Summary
Key Responsibilities
- Lead and manage all microbiology laboratory operations.
- Ensure compliance with GMP, GLP, and applicable regulatory guidelines.
- Oversee environmental monitoring, water system monitoring, utility monitoring, and cleanroom qualification.
- Review and approve microbiological test results, SOPs, protocols, reports, and validation documents.
- Manage sterility testing, microbial limit testing, endotoxin testing, media preparation, and culture maintenance.
- Investigate out-of-specification (OOS), out-of-trend (OOT), deviations, and contamination events, and implement effective CAPA.
- Support regulatory inspections, customer audits, and internal quality audits.
- Ensure laboratory compliance, equipment qualification, calibration, and maintenance.
- Develop, mentor,
and lead the microbiology team to achieve departmental objectives.
- Coordinate with QA,QC, Production, Engineering, and Validation teams for quality and compliance initiatives.
Qualifications:
- Master's degree in Microbiology.
Experience (mandatory)
- Minimum 7-8 years of experience in pharmaceutical microbiology.
- Minimum 3 years of hands-on experience in sterile injectable manufacturing is mandatory.
- Proven experience in leading a microbiology team or department.
Required Skills:
- Strong knowledge of microbiological testing and laboratory practices.
- In-depth understanding of sterile manufacturing processes.
- Excellent knowledge of GMP, GLP, data integrity, and regulatory requirements.
- Experience with environmental monitoring programs and contamination control strategies.
- Robust leadership, analytical, problem-solving, and decision-making skills.
- Effective communication and team management abilities.
- Experience handling regulatory
📌 Microbiology Head (Bal Kalan)
🏢 Systacare Remedies
📍 Bal Kalan