AM - Quality Control

ConfidentialBharuch, India

11 days ago

Job description

Position

Assistant Manager / Deputy manager- QC

Grade : L1 / L2

Business Unit / Function

Department – Quality Control

Location

Bharuch SEZ

Reports to

QC Head

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 & compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site.

Key Responsibilities

(Performance Indicators)

Regularize the QC activities as per cGMP requirements.

Regulatory & Pharmacopeia requirement for lab compliance.

Review of hybrid & electronic data for IPQC & FG analysis.

Analytical method validation, OOS & OOT.

Knowledge about IMS system (ISO 9001 : 2015, ISO 14001 : 2015 OHSAS 18001 : 2007, and cGMP.

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

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

Resolve the trouble shooting related to QC activities.

Training to subordinate & employment of 21 CFR Part 211, 111 with data integrity (Part-11) compliance in lab.

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

No. of Reportees

2-3 numbers

Qualification & Experience

M.Sc. (Chemistry) with 8-12 yrs.

y Competencies

(Technical, Functional & Behavioral)

Responsible for implementation & compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP.

Hand-on experience as Reviewer of electronic data & hybrid system in regulatory environment (US-FDA, WHO etc.)

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

Site Quality Head

CQA & RA Head

Unit HR Head

Skills Required

Hplc, Iso9001, Cgmp, Haccp, Icp, Ftir, melting point

Quality Control • Bharuch, India