Section Lead - FP/ RM (Quality Control)

Unison Pharmaceuticals

1: Raw Material (RM) Lead - Quality Control

Designation : Asst. Manager/Deputy Manager

Role Objective:

Lead the planning, sampling, testing, and timely release of raw materials.

• Approve analytical reports, ensure pharmacopeial compliance (IP/BP/USP/Ph.Eur.).
• Coordinate with QA, Production, and Warehouse for material prioritization.
• Investigate and close RM-related OOS, OOT, and deviations.
• Monitor vendor quality trends and assist in vendor qualification reviews.
• Supervise testing and approval of printed/unprinted packaging materials.
• Ensure verification of dimensions, artwork, shade card, GSM, bursting strength, etc.
• Review and approve packaging specifications and COAs.
• Coordinate with QA and procurement on packaging change controls.
• Ensure timely documentation and logbook maintenance.
• Monitor equipment calibration and instrument usage (IR, UV, FTIR).
• Ensure data integrity and adherence to ALCOA+ principles.
• Support audits and implement CAPAs for RM/PM observations.
  

Qualifications:

• M.Sc. (Chemistry) / B.Pharm / M.Pharm
• 8-15 years of QC experience, particularly in RM/PM
• Strong regulatory knowledge and audit exposure
  

Key Skills:

• Analytical knowledge of RM/PM
• Compliance with pharmacopeias & specifications
• Effective coordination with warehouse, QA, and procurement
• Proficiency in ERP/SAP and LIMS systems
• Strong documentation, team handling, and troubleshooting skills
  

2: FP (Finished Product) Lead - Quality Control

Designation : Asst. Manager/Deputy Manager

Role Objective:

To lead the testing, review, and release of Finished Products (FP) ensuring adherence to regulatory standards, timely market release, and data accuracy within a GMP-compliant framework.

Finished Product QC Oversight:

• Plan and lead analysis of FP batches (Assay, Dissolution, Content Uniformity, Related Substances, etc.).
• Approve analytical reports and ensure timely batch release in collaboration with QA.
• Monitor stability testing, trending, and shelf-life management.
• Oversee FP investigations OOS/OOT/Deviations and implement CAPAs.
• Review and approve method validation/transfer protocols for FP.
• Ensure qualification, calibration, and maintenance of HPLC, GC, UV, IR, etc.
• Troubleshoot instrument/method-related challenges to avoid delays.
• Ensure compliance with regulatory guidelines (USFDA, MHRA, WHO, etc.).
• Review and approve FP-related SOPs, STPs, GTPs, and specifications.
• Maintain ALCOA+ data integrity in FP QC documentation.
• Face audits and defend QC-FP processes and documentation.
  

Qualification & Experience:

• M.Sc. (Analytical Chemistry) / M.Pharm / B.Pharm
• 1015 years of experience in QC with strong FP testing and regulatory exposure
• Good understanding of global pharmacopeias and ICH guidelines