Unison Pharmaceuticals Pvt. Ltd - Urgent Openings for Quality Control / Production (Packing) / Regulatory Affairs - Apply Now

 

Opening for Quality Control – HPLC

Experience: 2-7 yrs

Key Accountabilities/ Responsibilities

1. HPLC Operation (Analyst)- Assay

• Collect worksheet and sample for analysis as per plan
• Check the instrument calibration details
• Purging the interior part of the instrument
• Take the columns as per worksheet and put in instrument
• Initiate solution preparation for analysis as per worksheet which majorly includes; Mobile Phase, Standard and sample
• Prepare HPLC sequence for analysis and get it review by reviewer
• As per the sequence initiate the analysis and online verify SSC criteria as per worksheet
• Post completion of the analysis perform documentation and send to reviewer
• Calculate final analysis result as per the standard formula mentioned in worksheet and match the result with worksheet range

2. HPLC Operation (Analyst)- Dissolution

• Collect worksheet and sample for analysis as per plan
• Check the instrument calibration details
• Purging the interior part of the instrument
• Take the columns as per worksheet and put in instrument
• Initiate dissolution solution preparation for analysis as per worksheet and also prepare dissolution medium
• Perform dissolution analysis as per the criteria mentioned in worksheet
• Post completion of the analysis perform documentation and send to reviewer
• Calculate final analysis result as per the standard formula mentioned in worksheet and match the result with worksheet range

3. HPLC Operation (Analyst)- Others

• RM- Assay, RS, IR
• In process- Assay by UV and HPLC
• PV Sample- Assay by UV and HPLC, Dissolution
• FP- Assay, Dissolution, RS, DT, Average weight, hardness, Friability, IR
• Cleaning validation

Candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements.

Opening for Production - OSD Packing

Experience: 2-5 yrs

Job Purpose:

This position provides front line leadership to direct reports in support of packing of drug products and drives a culture of compliance, ownership and continuous improvement with thorough working knowledge of equipment, processes and systems.

Key Accountabilities/ Responsibilities

1. All Packing Material and Manpower Handling

• Supervise cleaning activity of blister and strip machines.
• Provide training to technicians for machines, equipment operation and for line clearance activities.
• Cross check the readiness of area, machine, temperature, humidity, differential pressure and di -punch as per SOP before going for line clearance.

2. Tablet and Capsule Process

• Supervise the process of online machine activity of tablets and capsule with blister and strip packing.
• Ensure the tablets and capsules are packed in appropriate strip and blister as per the SOP.
• Provide training to technicians for operating tablets and capsule packing machines.
• Ensure pre availability/supply of tablets for strip and blister packing machine.

3. Sample Activity

• Checks the sample tablet availability in quarantine area.
• In BPR maintain batch registered for tablet sample as per the unit count

4. Manpower Handling

• Supervise the packing activity of tablet and ensure compliance to all GDP and GMP requirements.
• Support the team members in resolving problems related to machines and packing processes.
• Distribute the responsibilities among team members based on the planning.

5. Leak Test

• Supervise the full leak test activity and check machine temperature, strip pressure and vacuum pressure as per BPR.
• Maintain strip and blister in process variation and if any problem found at these stage inform to operator.

6. BPR Activities

• Perform blister cutting and coating, hologram activities and in process of strip packing.
• Enter leak test temperature and working condition in BPR
• Enter carton coding and line clearance activity related to previous product stereo restoring.
• Enter data of tablet and capsule process in BMR with date, release status, drums weight.

7. Others

• Any other responsibility assigned by management in the favor of organization.
• Transfer the PVC/ Alum- alum scarp of tablets and capsule to waste room.
• Enter details and perform overall process of equipment log book.

For all the positions, candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements.

Opening For Regulatory Affairs (Europe Market)

Experience: 3-6 yrs

Key Accountabilities/ Responsibilities

• Work on variety of Regulatory related submissions
• Ensure timely authoring and submission of dossiers (Module 2-5) for regulated regions such as Europe, Australia, South Africa, New Zealand and Canada in the eCTD format including familiarity with publishing activities.
• Preparation of quality responses to the deficiency letters from various agencies within agreed time frame.
• Co-ordinate with various departments to obtain essential scientific data and documents required for dossier preparation and query responses.
• Involve in review of source documents for in-house: product development report, specification (excipients, API and finished product), manufacturing batch record, analytical method, validation report, validation protocol etc.
• Actively participate in the evaluation of regulatory compliance of document/product/ process/test methods changes.
• Identification of correct change code and authoring of variation package to maintain product life cycle in a timely manner.
• Provide regulatory insights and support for contract manufacturing projects (CMO/CDMO).
• Preform gap analysis for extension of dossier to other territories as per country specific requirements.
• Identifies and communicates risks and issues impacting project progression.
• Assist in the development of Regulatory CMC strategies for assigned products and projects.
• Update/Maintenance of database with regulatory submission and approval.
• Any other regulatory activity as per the business needs.

Desired Candidate Profile

• Experience in regulated markets for IR and modified solid oral dosage form (Europe, Canada, Australia).
• Work exposure: Candidate(s) having previous exposure in EU product life cycle management/variation and Health Canada filings are preferable.
• Core competencies: Strong technical understanding of ICH/EU/Health Canada guidance, time management skills, right first time approach, work with minimal supervision.

For all the positions, candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements.

Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm

Location: Ahmedabad

Interested candidates may also email their resume to career@unisonpharmaceuticals.com