Qc Manager

Role & responsibilities

• Oversee and manage the Quality Control department to ensure efficient laboratory operations.
• Develop, implement, and maintain QC protocols and Standard Operating Procedures (SOPs) in compliance with GMP, FDA, MHRA, and other regulatory standards.
• Supervise and mentor QC staff, providing training and technical support to maintain high performance.
• Conduct routine and non-routine testing of raw materials, intermediates, and finished pharmaceutical products.
• Ensure timely and accurate analytical testing, stability studies, and method validations.
• Investigate and resolve out-of-specification (OOS) and out-of-trend (OOT) results, implementing corrective and preventive actions (CAPA).
• Coordinate with Production, Quality Assurance, and R&D teams to ensure smooth manufacturing and compliance processes.
• Review and approve analytical data, reports, and COAs (Certificates of Analysis).
• Ensure proper calibration, validation, and maintenance of laboratory instruments and equipment.
• Manage laboratory documentation, ensuring compliance with data integrity guidelines.
• Participate in regulatory inspections, audits, and customer visits, providing necessary documentation and responses.
• Stay updated on industry trends, regulatory changes, and advancements in analytical techniques.

Qualifications & Experience:

• Bachelor's/Masters degree in Pharmacy, Chemistry, Microbiology, or a related field.
• Minimum [X] years of experience in Quality Control within the pharmaceutical industry.
• Strong knowledge of GMP, GLP, ICH guidelines, and regulatory requirements (FDA, MHRA, WHO, etc.).
• Hands-on experience with analytical techniques such as HPLC, GC, FTIR, UV-Vis Spectrophotometry, etc.
• Experience in handling QC audits, deviations, OOS investigations, and CAPA implementation.
• Strong leadership, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills.
• Proficiency in laboratory data management systems and Microsoft Office tools.

Preferred Skills:

• Knowledge of pharmaceutical microbiology and environmental monitoring.
• Experience with LIMS (Laboratory Information Management Systems).
• Certifications in Quality Management Systems (QMS) would be an advantage.

Employment Type: Full-time

Compensation: Competitive salary based on experience and industry standardOversee and manage the Quality Control department to ensure efficient laboratory operations.

• Develop, implement, and maintain QC protocols and Standard Operating Procedures (SOPs) in compliance with GMP, FDA, MHRA, and other regulatory standards.
• Supervise and mentor QC staff, providing training and technical support to maintain high performance.
• Conduct routine and non-routine testing of raw materials, intermediates, and finished pharmaceutical products.
• Ensure timely and accurate analytical testing, stability studies, and method validations.
• Investigate and resolve out-of-specification (OOS) and out-of-trend (OOT) results, implementing corrective and preventive actions (CAPA).
• Coordinate with Production, Quality Assurance, and R&D teams to ensure smooth manufacturing and compliance processes.
• Review and approve analytical data, reports, and COAs (Certificates of Analysis).
• Ensure proper calibration, validation, and maintenance of laboratory instruments and equipment.
• Manage laboratory documentation, ensuring compliance with data integrity guidelines.
• Participate in regulatory inspections, audits, and customer visits, providing necessary documentation and responses.
• Stay updated on industry trends, regulatory changes, and advancements in analytical techniques.

Qualifications & Experience:

• Bachelor's/Master’s degree in Pharmacy, Chemistry, Microbiology, or a related field.
• Minimum [X] years of experience in Quality Control within the pharmaceutical industry.
• Strong knowledge of GMP, GLP, ICH guidelines, and regulatory requirements (FDA, MHRA, WHO, etc.).
• Hands-on experience with analytical techniques such as HPLC, GC, FTIR, UV-Vis Spectrophotometry, etc.
• Experience in handling QC audits, deviations, OOS investigations, and CAPA implementation.
• Strong leadership, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills.
• Proficiency in laboratory data management systems and Microsoft Office tools.

Preferred Skills:

• Knowledge of pharmaceutical microbiology and environmental monitoring.
• Experience with LIMS (Laboratory Information Management Systems).
• Certifications in Quality Management Systems (QMS) would be an advantag