Sr Exec - Quality Control

Position

Executive / Sr. Executive- QC

Grade : A3 A4

Business Unit / Function

Department - Quality Control

Location

Bharuch; SEZ;;;;

Reports to

Lab In charge-QC;

Summary of Job

(Purpose/ objective of the job Department Organogram to be enclosed)

• candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site.

Key Responsibilities

(Performance Indicators)

• Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP, USFDA, FSSC - 22000, NABL.

• Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc.

• Regularize the QC activities as per cGMP requirements.

• RM, PKG, In-process and FG sampling and Analysis.

• Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches.

• Day to day monitoring and execution online all IPQC and FG analysis activities.

• Resolve the trouble shooting related to QC activities.;

• Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11)

• Awareness about responsible care (Environment, Health, Safety and Security)

No. of Reportees

Qualification and Experience

• M.Sc. (Chemistry) with 2 - 6 yrs.

Key Competencies;

(Technical, Functional and Behavioral)

• Handling, Calibration and Hand-on experience of all QC instruments.

• Compliance of 21 CFR Part-11.

• Troubleshooting related to QC analytical instrument