Quality Assurance Manager in Pharmaceutical Company

ABP Empower

Urgent opening for Quality Assurance Manager in Pharmaceutical Company @ SOLAN Himachal Pradesh

Experience - 15+ Years in Quality of Pharmaceutical Tablets Manufacturing Plant

Salary - 1 Lakh per month

Job Responsibilities

Ensure strict adherence to FDA, EMA, ICH, USP, and EP.

Develop, implement, and maintain a robust QMS.

Oversee and coordinate validation and qualification activities.

Conduct risk assessments to identify potential quality risks.

Manage change control processes to ensure that any changes.

Lead investigations into deviations, out-of-specification results, and complaints.

Provide oversight and support to all quality assurance activities.

Qualify and manage vendors to ensure they meet quality standards.

Ensure accurate and timely documentation of quality-related activities.

Lead and develop a high-performing quality assurance team.

Drive a culture of continuous improvement by implementing lean methodologies.

Support regulatory submissions (., NDAs, ANDAs, variations).

Investigate and analyze market complaints.

Manage deviation and change control processes.

Oversee and coordinate stability studies to assess product quality over time.

Ensure that manufacturing areas, HVAC systems, and water systems meet quality standards.

Validate cleaning procedures to ensure effective removal of contaminants.

Oversee in-process quality assurance activities to ensure product quality throughout the manufacturing process.

Develop, review, and approve standard operating procedures (SOPs), batch manufacturing records (BMRs).

Ensure that equipment is qualified and calibrated according to appropriate standards.

Ensure the implementation of compliance with all audits and inspections.

Promote a culture of self-inspection among employees to identify and address quality issues.

Ensure that artwork and labelling for products comply with regulatory requirements and company standards.

Conduct annual product reviews to assess product quality and identify

• Experience

  15 - 25 Years

• No. of Openings

  2

• Education

  Professional Degree

• Role

  Quality Assurance Officer

• Industry Type

  Pharma / BioTech / Clinical Research

• Gender

  Male

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office

• Face interview location

  Solan H.P