QA/QC job vacancy at Bhiwani in Rajasthan Aushdhalaya

Rajasthan Aushdhalaya

Job Details / Candidate Eligibility Criteria

Key Responsibilities
Quality Assurance (QA)

Ensure compliance with Good Manufacturing Practices (GMP), GLP, and regulatory requirements (USFDA, MHRA, WHO, CDSCO, etc.).

Review, approve, and maintain SOPs, BMRs, BPRs, and validation protocols.

Perform internal audits, vendor audits, and self-inspections to ensure adherence to quality standards.

Handle deviation management, change control, OOS (Out of Specification), OOT (Out of Trend), and CAPA implementation.

Oversee qualification and validation activities (equipment, facility, utilities, cleaning validation, process validation).

Participate in regulatory inspections and ensure timely closure of observations.

Train staff on quality systems, regulatory updates, and cGMP compliance.

Quality Control (QC)

Conduct and supervise analysis of raw materials, intermediates, in-process, and finished products as per pharmacopeia (IP, BP, USP, EP).

Operate and maintain analytical instruments like HPLC, GC, UV, FTIR, Dissolution Tester, etc.

Review and document analytical results ensuring compliance with SOPs and regulatory standards.

Implement and monitor stability studies of products.

Ensure proper calibration and maintenance of lab instruments and equipment.

Manage laboratory documentation, data integrity, and ensure ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available).
Key Skills Required

Strong knowledge of GMP, GLP, ICH, and regulatory guidelines.

Hands-on experience in QA/QC documentation, validation, and audits.

Practical knowledge of analytical techniques (HPLC, GC, UV, etc.).

Familiarity with regulatory inspections (USFDA, MHRA, WHO, etc.).

Excellent problem-solving, communication, and compliance monitoring skills.

Qualifications & Experience

Education: B.Pharm / M.Pharm / M.Sc. (Chemistry, Biotechnology, or related field).

Experience: 2–7 years (for Executive/Sr. Executive roles) in a pharmaceutical formulation/API manufacturing unit.

Preferred Background: Exposure to regulated markets and experience in handling audits.
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