Job Description

Key Duties & Responsibilities

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1 Plan, allocate and conduct routine analyses of In-process materials, Raw materials, Packing material, finished goods and stability samples within given time schedule. Responsible for the overall operational and technical efforts of QC lab, by directing the day-to-day operations in addition to execution of lab testing as per GMP.

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2 Verify all processes are conforming to established quality standards and required customer MOA.

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3 Interpret test results, compare with established specifications, and control limits, and make

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recommendations on the appropriateness of data for release.

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4 Investigate customer complaints regarding quality issues and close with proper CAPA.

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5 Communicate quality control information to all relevant organizational departments.

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6 Monitor the performance of quality control systems to ensure effectiveness and efficiency.

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7 Implement quality control training programs.

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8 Experience reviewing and approving method transfer and method validation protocols and reports

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9 Experience reviewing and approving RM, FG, PM specification and method of Analysis and Stability Protocols for final product.

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10 Experience performing oversight and audits of laboratories.

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11 To check timely Calibration of QC instruments, General Maintenance, AMC and update related history card.

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12 Responsible for NABL accreditation certificate.

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13 To ensure the quality of raw materials, packaging materials and finished products are compliant with the approved specifications

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14 To ensures that the Monitoring of the calibration program of equipment is done.

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15 To provide technical support while troubleshooting problems such as Instrument, software, data etc.

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16 Responsible for resource requirement in quality control department including Man and Machine.

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17 To respond to customer query, DMF query with documentation.

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18 Maintain a safe and healthy work workplace by following standards, procedures, and legal

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regulations.

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19 Responsible for new product method development.

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Education: B.Sc. / M.Sc. in Chemistry or Ph. D

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Experience: Min15 years in pharma quality control labs

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Competencies & Skillsets

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Functional / Technical Behavioral

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1) Planning and Execution.

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2) Quality management System (QMS)

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3) Data Integrity.

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4) External/Internal Audits.

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5) Effective team management.

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6) Analytical Method Validation.

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7) Qualification of Instruments.

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1) People Manager

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2) Flexibility

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3) Ownership

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4) Conflict management

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5) Interpersonal skill

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Looking a candidate from Local Ahmedabad (Who is ok with the Sanand location) and who know the Gujarati language as well.

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PLs share you CV on [email protected]

📌 Senior Quality Assurance Manager (Ahmedabad)
🏢 UNLOCK BUSINESS CONSULTING
📍 Ahmedabad